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Mineral trioxide aggregate as a pulpotomy medicament: an evidence-based assessment.

Abstract

Aim: The principles of evidence-based dentistry were used to compare mineral trioxide aggregate (MTA), formocresol (FC), ferric sulphate (FS) and calcium hydroxide (CH) as primary molar pulpotomy medicaments. Methods: Electronic databases were searched and sieved for relevant papers by examining titles, abstracts and finally full texts. Included were randomized clinical trials (RCTs) and clinical trials (CTs) comparing the clinical and radiographic successes of MTA, FC, FS and CH pulpotomies. Data were extracted and common odds ratios (CORs) were derived by fixed effects meta-analysis (direct or indirect MA). Mean clinical and radiographic success rates from relevant study arms were examined. Results: Eighteen RCTs and 10 CTs (total 1,260 molars) were identified to compare MTA and FC. Direct MAs found MTA was significantly more successful clinically (COR=3.11; 95%CI=1.09-8.85) and radiographically (COR=4.50; CI=1.78--11.42) than FC, and clinical and radiographic data confirmed this. Fourteen RCTs and 4 CTs (total 959 molars) were identified to compare MTA and FS. Indirect MAs found no statistically significant difference in clinical successes, but a statistically significant difference in the radiographic successes of MTA and FS (COR=4.69; CI=1.70--12.95). Clinical and radiographic data showed MTA was significantly more successful than FS. Nine RCTs and 7 CTs (total 531 molars) were identified to compare MTA and CH. Indirect MAs found statistically significant differences in the clinical (COR=6.48; CI=1.75-24.0) and radiographic (COR=10.47; CI=3.35-32.76) successes of MTA and CH. Clinical and radiographic data confirmed MTA was significantly more successful than CH. Conclusion: Currently-available evidence suggests MTA compared with FC, FS and CH as a pulpotomy medicament resulted in significantly higher clinical and radiographic successes in all time periods up to exfoliation.

Key words: Evidence-based dentistry, mineral trioxide aggregate, formocresol, ferric sulphate, calcium hydroxide

Introduction

Conservative pulp therapy for primary teeth aims to maintain pulp vitality, reduce the need for a pulpectomy, and promote the integrity and retention of such teeth until appropriate exfoliation. A pulpotomy is usually performed for carious exposures of primary teeth with normal pulp or reversible coronal pulpitis, or primary teeth pulpally exposed by trauma. Clinicians are reluctant to directly cap cariously-exposed primary pulps with calcium hydroxide (CH) since internal resorption (IR) may be stimulated [Ranly and Garcia-Godoy, 2000]. Unlike permanent teeth, success rates for direct pulp capping in primary teeth are lower than for indirect pulp capping and pulpotomy [Kopel, 1992]. This is attributed to procedural considerations and the higher cellular content of primary pulp, where undifferentiated mesenchymal cells may differentiate into odontoclasts in response to caries or the pulp medicament, leading to IR [Kennedy and Kapala, 1985; Kopel, 1992]. A pulpotomy requires healthy radicular pulp capable of healing after amputation of inflamed or infected coronal pulp [Fuks and Eidelman, 1991]. Pulpotomy procedures may be classified by treatment objectives: devitalization, preservation or regeneration [Ranly, 1994].

Despite concerns of toxicity, mutagenicity and carcinogenicity [Swenberg et al., 1980; Goldmacher and Thilly, 1983; Ranly and Horn, 1987], formocresol (FC) remains a commonly-used primary tooth pulpotomy medicament [Hingston et al., 2007]. Various clinical and radiographic success rates (59-100%) have been reported [Mejare, 1979; Naik and Hegde, 2005], attributed to intra-patient variations, clinician and assessor factors, FC concentrations and application times, coronal seal, and study durations. Caries control measures and a hermetic coronal seal can improve success rates [Holan et al., 2002; Vij et al., 2004]. Histologic findings in pulps treated with FC range from total necrosis to vital pulp with inflammation [Rolling and Lambjerg-Hansen, 1978]. Typically, a zone of necrosis is followed by a zone of fixation; beneath this the inflammatory infiltrate leads to normal pulp [Alacam, 1989] Healing without inflammation is not seen [Alacam, 1989], and although clinical success has been attributed to the antimicrobial characteristics of FC [Hill et al., 1991], success rates decline in the long term [Rolling and Thylstrup, 1975]. Formaldehyde has been classified as a human carcinogen [IARC, 2004]. Although FC is unlikely to pose a cancer risk if used judiciously [Milnes, 2006], it is prudent for the profession to pursue alternative medicaments.

FS was first investigated as a pulpotomy medicament to arrest bleeding prior to CH placement over amputated monkey pulps [Landau and Johnsen, 1988]. FS agglutinates blood proteins and a ferric ion-protein complex seals severed blood vessels mechanically. Once pulp haemorrhage is controlled, chronic inflammation and IR associated with clot formation may be prevented [Schroder and Granath, 1971]. Animal histological studies have shown FS and FC produce similar pulpal responses [Cotes et al., 1997; Fuks et al., 1997a].

Calcium hydroxide (CH) promotes pulp healing with dentine regeneration and calcific bridge formation [Zander, 1939; Doyle et al, 1962]. Reported success rates vary widely (50-100%), due to the wide range of CH preparations used and variations in study durations and sample sizes [Schroder, 1978; Heilig et al., 1984; Huth et al., 2005; Markovic et al., 2005]. As a pulpotomy medicament, CH is more technique-sensitive than FC, relying on pulpal healing with or without a calcific barrier, and extensive IR may follow [Doyle et al., 1962; Schroder, 1978]. The IR may be related to the residual clot prior to CH application [Schroder, 1973], previous chronic inflammation of radicular pulp [Schroder, 1978], or the inability of CH to provide a long term seal [Cox et al., 1996], resulting in bacterial microleakage and pulp inflammation.

Mineral trioxide aggregate (MTA) was first used as a root-end filling. Marketed as ProRoot[TM] (Dentsply Tulsa Dental, Tulsa, OK, USA) and Angelus[R] (Industria de Produtos Odontologicos Ltda, Londrina, Brazil), MTA contains fine hydrophilic particles of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. Powder hydration forms a colloidal gel that sets in about 3 hours. White MTA was developed by excluding iron compounds [Camilleri et al., 2005]. Although MTA is essentially CH in a silicate matrix [Camilleri et al., 2005], MTA appears more biocompatible with pulp than CH [Aeinehchi et al., 2002], has excellent sealing ability [Al-Hezaimi et al., 2005], and can stimulate cytokine expression and cell adhesion [Mitchell et al., 1999; Huang et al., 2005]. Used for pulp capping and pulpotomy in humans, MTA preserves normal pulpal architecture and induces thick dentine bridges with little or no signs of inflammation [Aeinehchi et al., 2002; Agamy et al., 2004]. As a root-end filling or furcation-repair material in animals, MTA exhibits excellent biocompatibility, consistently regenerating cementum and bone [Torabinejad et al., 1997; Yildirim et al., 2005].

Evidence-based dentistry (EBD) can aid dentists in decision-making, by selecting currently-available knowledge and summarizing it in a clinically-useful manner. Research using the principles of EBD utilizes an acronym 'PICOT' to construct a question with a practical outcome, where 'P' represents the population of interest, 'I' represents the intervention, 'C' represents the comparison, 'O' represents the outcome, and 'T' represents time.

The aim of this study was to use the principles of EBD to answer a PICOT question relating to the efficacy of MTA, FC, FS and CH as primary molar pulpotomy medicaments. The two specific objectives were to:

* Compare the clinical and radiographic successes of mineral trioxide aggregate, with formocresol, ferric sulphate and calcium hydroxide as pulpotomy medicaments in human primary molars, and

* Develop recommendations on medicament selection for clinicians.

Methods

The PICOT question was: (P) In human carious primary molars with reversible coronal pulpitis, (I) does MTA as a pulpotomy medicament, (C) compared with FC, FS and CH, (O) result in clinical and radiographic success, (T) in all time periods up to exfoliation?

Literature search. A systematic search identified and sieved relevant papers for inclusion, using previously-described steps and procedures [Loh et al., 2004]. Four electronic databases [Ovid Medline, ISI Web of Knowledge-Science Citation Index, Ovid EBM Reviews-Cochrane Central Register of Controlled Trials, Ovid EBM Reviews-Cochrane Database of Systematic Reviews] were searched (1966 to October 2005), using key words and Boolean operators for citations relevant to the PICOT question (Figure 1). The search strings used were:

* Primary teeth and pulp therapy,

* Primary molars and pulp therapy,

* Deciduous molars and pulp therapy,

* Primary teeth and pulps,

* Primary molars and pulps,

* Deciduous molars and pulps,

* Pulpotomy or pulp therapy,

* Mineral trioxide aggregate,

* Formocresol,

* Ferric sulphate or ferric sulfate, and

* Calcium hydroxide and pulp.

Limiting to human studies written in English and removing all duplications, papers relevant to MTA pulpotomy ([MTA.sub.P]) and/ or FC pulpotomy ([FC.sub.P]; n = 1,245), [MTA.sub.P] and/or FS pulpotomy ([FS.sub.P]; n = 1,225) and [MTA.sub.P] and/or CH pulpotomy ([CH.sub.P]; n = 1,576) were identified (Figure 1).

Preliminary sieve by title and secondary sieve by abstract. Paper titles were assessed for relevance to the PICOT question and those deemed relevant to [MTA.sub.P] and/or [FC.sub.P] (n = 398), [MTA.sub.P] and/or [FS.sub.P] (n = 371), and [MTA.sub.P] and/or [CH.sub.P] (n = 556), were submitted to secondary sieving, where available abstracts were examined, limiting the search to actual clinical trials (Figure 1). Papers relevant to [MTA.sub.P] and/or [FC.sub.P] (n = 117), [MTA.sub.P] and/or [FS.sub.P] (n = 68), and [MAT.sub.P] and/or [CH.sub.P] (n = 82), remained for ranking of evidence.

Appraisal and ranking of evidence. Evidence categories were assigned to papers based on titles and abstracts and ranked hierarchically as: (1) systematic reviews (SRs) and meta-analyses (MAs), (2) experimental studies, (3) cohort studies, (4) case-control studies, (5) cross-sectional studies, (6) case reports and (7) undetermined studies due to inadequate information. Full texts of experimental studies and undetermined studies were sought and classified by title, abstract, methodology, and relevance. Irretrievable papers were deemed grey literature Full texts of the remaining papers were further appraised and ranked hierarchically as (1) SRs and MAs, (2) randomized clinical trials (RCTs), (3) CTs, (4) cohort studies, (5) case-control studies, (6) cross-sectional studies and (7) case-reports [Sutherland, 2001]. Manual checking references from retrieved articles and searching Google[R] yielded additional relevant titles which were screened by abstracts and their full texts were appraised and ranked. Relevant RCTs and CTs pertinent to [MTA.sub.P] and/or [FC.sub.P] (20 + 36 = 56), [MTA.sub.P] and/or [FS.sub.P] (15 + 18 = 33), and [MTA.sub.P] and/or [CH.sub.P] (17 + 14 = 31) were sieved by inclusion/exclusion criteria (tertiary sieve; Figure 1). Data from the relevant papers remaining were extracted for MA.

[FIGURE 1 OMITTED]

Inclusion and exclusion criteria. Included were studies on healthy subjects reporting clinical or radiographic outcomes, and using no additional interventions other than the medicament of interest. Only studies of restorable carious primary molars with reversible pulpitis and free of clinical or radiographic signs of pulp pathology were included. Excluded were retrospective studies, and studies of teeth other than primary molars, or primary molars with clinical or radiographic signs of pathology.

Application of meta-analysis. The meta-analyses (MAs) included direct (DMA), naive indirect (NMA) and adjusted indirect (AMA) techniques [Loh et al, 2004; Higgins and Green, 2005]. In DMA, teeth in one group were compared with teeth in another group within the same trial. A fixed effects MA was used, assuming the treatment effect was similar in all study populations and differences were due only to within-study variation [Higgins and Green, 2005]. Study populations were examined for heterogeneity using the [integral]2 and I2 tests of heterogeneity [Higgins and Green, 2005].The statistic I2 was computed as the c2 test is poor at detecting true heterogeneity and a non-significant result cannot be taken as evidence of homogeneity [Higgins et al., 2003]. The [chi square] test has low power where trials have small sample sizes or are few in number [Higgins et al., 2003]. The I2 statistic quantifies the effect of heterogeneity, providing a measure of inconsistency in the studies' results [Higgins et al., 2003].

Treatment effects were measured using odds ratios (ORs) [Loh et al., 2004]. The 95% confidence intervals (95% CI) and standard error (SE) of the logarithm of the OR for each paper were calculated [RevMan analyses]. The common odds ratio (COR) was calculated using Mantel-Haenszel (MH) weights to combine individual ORs [RevMan analyses]. A COR value exceeding 1 indicated the 'test' therapy was more successful than the 'control' therapy and a COR less than 1 indicated the 'control' therapy was more successful than the 'test' therapy [Loh et al., 2004]. The RevMan 4.2 program was used to pool individual ORs, producing the COR and a forest plot [RevMan Analyses].

In NMA, data were extracted from relevant arms only of all papers meeting the inclusion criteria of the tertiary sieve [Loh et al., 2004]. Percentage success rates were extracted from the papers or calculated from available data [Loh et al., 2004]. Mean percentage success rates ([+ or -] SD) for each arm were compared using the Student's t test and alpha set at p < 0.05.

In AMA, indirect comparisons of two pulpotomy medicaments were made by analysing RCTs which directly compared one of the two medicaments of interest with a common comparator (in order to preserve the randomization of the original groups) [Bucher et al., 1997]. The [FC.sub.P] was denoted the common comparator as historically [FC.sub.P] has been reported widely. Papers meeting the inclusion criteria of the tertiary sieve were subjected to an additional inclusion criterion for AMA; only RCTs using [FC.sub.P] were eligible. Three CORs were calculated from DMAs of trials directly comparing [MTA.sub.P] and [FC.sub.P] ([COR.sub.1]), [FS.sub.P] and [FC.sub.P] ([COR.sub.2]), and [CH.sub.P] and [FC.sub.P] ([COR.sub.3]). The adjusted indirect comparisons for [MTA.sub.P] and [FS.sub.P], and [MTA.sub.P] and [CH.sub.P] were the differences between [COR.sub.1] and [COR.sub.2], and [COR.sub.1] and [COR.sub.3], respectively [Bucher et al., 1997].

Results

Meta-analysis comparing mineral trioxide aggregate and formocresol. Five RCTs (total 299 molars: 147 [FC.sub.P], 152 [MTA.sub.P]) were analyzed by DMA (Table 1). Of 147 molars treated by [FC.sub.P], 134 were clinically successful (91%) and 125 were radiographically successful (85%). Of 152 molars treated by [MTA.sub.P], 148 were clinically successful (97%) and 147 were radiographically successful (97%). The mean clinical success rates for the 5 papers reporting [MTA.sub.P] were 97.6% ([+ or -] 2.5), and 90.8% ([+ or -] 5.1) for the 5 papers reporting [FC.sub.P]. The mean radiographic success rates for the 5 papers reporting [MTA.sub.P] were 96.8% ([+ or -] 3.3), and 85.4% ([+ or -] 5.7) for the 5 papers reporting [FC.sub.P].

The forest plot (Figure 2a) shows the ORs and CI for the clinical success of [MTA.sub.P] and [FC.sub.P] in the 5 papers that were subjected to meta-analysis. In the centre of this and subsequent plots, the OR for each paper is represented by a square and the CI by a horizontal line. The square size represents the MH weight % for the paper in the MA (calculated by dividing the paper weight by the summed weights of all papers, multiplied by 100%). At the base of the plot, the diamond centre denotes the COR; the horizontal width located entirely to the right of the vertical line (of no statistical significance), indicates [MTA.sub.P] was significantly more successful (3.11 times) than [FC.sub.P]. The clinical data were deemed homogenous (c2 = 1.21; d.f. = 4; p = 0.88; I2 = 0). The individual ORs for clinical data were calculated and pooled, indicating [MTA.sub.P] was significantly more successful clinically (3.11 times; p = 0.03) than [FC.sub.P] ([COR.sub.1] = 3.11; SE. = 0.53; CI = 1.09 - 8.85). The diamond in Figure 2b is located entirely to the right of the vertical line, indicating [MTA.sub.P] was significantly more successful radiographically (4.50 times) than [FC.sub.P]. The radiographic data were deemed homogenous (c2 = 1.93; d.f. = 4; p = 0.75; I2 = 0). The ORs for radiographic data were calculated and pooled, indicating [MTA.sub.P] was significantly more successful radiographically (4.50 times; p = 0.002) than [FC.sub.P] (COR1 = 4.50; SE. = 0.47; CI = 1.78 - 11.42).

In total, 1,260 molars (1,059 [FC.sub.P], 201 [MTA.sub.P]) from 28 studies were analysed by NMA (Table 2). The mean clinical success rate for the 8 papers reporting [MTA.sub.P] was significantly higher than for the 26 papers reporting [FC.sub.P] (98.5% [+ or -] 2.3; CI = 92.85 - 104.2 vs 91.7% [+ or -] 8.8; CI = 88.60 - 94.87; p = 0.041). The mean radiographic success rate for the 8 papers reporting [MTA.sub.P] was significantly higher than for the 26 papers reporting [FC.sub.P] (98.0% [+ or -] 3.0; CI = 92.38 - 103.6 vs 85.7% [+ or -] 8.7; CI = 82.54 - 88.77; p = 0.000).

Meta-analysis comparing mineral trioxide aggregate and ferric sulphate. A total of 18 papers (14 RCTs, 4 CTs) were analysed by NMA; 12 of the RCTs were analysed by AMA also. The total sample from the 18 studies was 603 molars (402 [FS.sub.P], 201 [MTA.sub.P]); 588 molars (387 [FS.sub.P], 201 [MAT.sub.P]) were used to calculate overall clinical success rates (Table 3). The mean clinical success rate for the 8 papers reporting [MAT.sub.P] was significantly higher than for the 9 papers reporting [FS.sub.P] (98.5% [+ or -] 2.3; CI = 95.81 - 101.2 vs 93.8% [+ or -] 4.4; CI = 91.24 - 96.32; p = 0.016). The mean radiographic success rate for the 8 papers reporting [MAT.sub.P] was significantly higher than for the 10 papers reporting [FS.sub.P] (98.0% [+ or -] 3.0; CI = 91.97 - 104.0 vs 80.1% [+ or -] 10.4; CI = 74.71 - 85.49; p = 0.000). To compare [MAT.sub.P] and [FS.sub.P] by AMA, ORs from 7RCTs directly comparing [FS.sub.P] and [FC.sub.P] were meta-analysed (lower panel, Table 4). Collectively, the 7 RCTs contained 660 molars (309 [FC.sub.P], 351 [FS.sub.P]). Of 309 molars treated by [FC.sub.P], 290 were clinically successful (94%) and 261 were radiographically successful (84%). Of 351 molars treated by [FS.sub.P], 330 were clinically successful (94%) and 292 were radiographically successful (83%) Clinical success rates were higher than radiographic success rates. The mean clinical success rates for the 7 papers reporting [FS.sub.P] (93.7% [+ or -] 5.1) and the 7 papers reporting [FC.sub.P] (92.7% [+ or -] 5.2) were similar. The mean radiographic success rates for the 7 papers reporting [FS.sub.P] (84.1% [+ or -] 8.4) and the 7 papers reporting [FC.sub.P] (83.0% [+ or -] 7.2) were similar.

[FIGURE 2 OMITTED]

In Figure 3a, the diamond crosses the vertical line, indicating no significant difference in clinical successes for [FS.sub.P] and [FC.sub.P]. The clinical data were deemed homogenous (c2 = 5.45; d.f. = 6; p = 0.49; I2 = 0). The individual ORs for clinical data were pooled, indicating [FS.sub.P] was clinically more successful than [FC.sub.P] but without statistical significance (COR2 = 1.08; s.e. = 0.33; CI = 0.57 - 2.02; p = 0.81). In Figure 3b, the diamond crosses the vertical line, indicating no significant difference in radiographic successes for [FS.sub.P] and [FC.sub.P]. The radiographic data were deemed homogenous (c2 = 3.85; d.f. = 6; p = 0.70; I2 = 0). The individual ORs for radiographic data were pooled, indicating [FS.sub.P] was radiographically less successful than [FC.sub.P] but without statistical significance (COR2= 0.96; SE. = 0.21; CI = 0.63 - 1.46; p = 0.84).

The adjusted indirect comparisons for [MAT.sub.P] and [FS.sub.P] were calculated from 12 RCTs (5 + 7) comprising 660 molars (Table 4). Results indicated [MAT.sub.P] was 2.88 times more likely to produce clinical success than [FS.sub.P] but without statistical significance (COR = 2.88; SE = 0.63; CI = 0.84 - 9.87; p = 0.09). Radiographically, [MAT.sub.P] was significantly more likely (4.69 times) to produce success than [FS.sub.P] (COR = 4.69; SE. = 0.52; CI = 1.70 - 12.95; p = 0.003).

Meta-analysis comparing mineral trioxide aggregate and calcium hydroxide. A total of 16 papers (9 RCTs, 7 CTs) were analysed by NMA; 8 RCTs were analysed by AMA also. Direct MA was not performed as only 1 paper directly compared [MAT.sub.P] and [CH.sub.P] [Rocha et al., 1999]. The total sample was 495 molars (294 [CH.sub.P], 201 [MAT.sub.P]; Table 5).The mean clinical success rate for the 8 papers reporting [MAT.sub.P] was significantly higher than for 9 papers reporting [CH.sub.P] (98.5% [+ or -] 2.3; CI = 90.28 - 106.7 vs 83.8% [+ or -] 14.8; CI = 76.03 - 91.53; p = 0.014). The mean radiographic success rate for the 8 papers reporting [MAT.sub.P] was significantly higher than for the 9 papers reporting [CH.sub.P] (98.0% [+ or -] 3.0; CI = 90.17 - 105.8 vs 78.8% [+ or -] 13.9; CI = 71.40 - 86.16; p = 0.002).

To compare [MAT.sub.P] and [CH.sub.P] by AMA, Ors from 3 RCTs directly comparing [CH.sub.P] and [FC.sub.P] were meta-analysed (lower panel, Table 6). The 3 RCTs contained 232 molars (125 [FC.sub.P], 107 [CH.sub.P]). Of 125 molars treated by [FC.sub.P], 113 were clinically successful (90%) and 108 were radiographically successful (86%). Of 107 molars treated by [CH.sub.P], 88 were clinically successful (82%) and 78 were radiographically successful (73%). The mean clinical success rate for the 3 papers reporting [CH.sub.P] was lower (82.0% [+ or -] 5.0) than that for the 3 papers reporting [FC.sub.P] (90.3% [+ or -] 6.0). The mean radiographic success rate for the 3 papers reporting [CH.sub.P] was lower (73.0% [+ or -] 6.1) than that for the 3 papers reporting [FC.sub.P] (86.3% [+ or -] 3.2). Similar SDs of the mean percentage success rates for [CH.sub.P] and [FC.sub.P] indicated similar data distributions.

[FIGURE 3 OMITTED]

In Figure 4a, the diamond just crosses the vertical line, indicating no significant difference in clinical successes for [CH.sub.P] and [FC.sub.P]. The clinical data were deemed homogenous (c2 = 0.60; d.f. = 2; p = 0.74; I2 = 0). The individual ORs for clinical data were pooled, indicating [CH.sub.P] was less successful clinically than [FC.sub.P] but without statistical significance (COR3 = 0.48; s.e. = 0.40; CI = 0.22 - 1.06; p = 0.07). In Figure 4b, the diamond location entirely to the left of the vertical line indicates [FC.sub.P] was significantly more successful radiographically than [CH.sub.P]. The radiographic data were deemed homogenous (c2 = 1.95; d.f. = 2; p = 0.38; I2 = 0). The individual ORs for radiographic data were pooled, indicating [CH.sub.P] was significantly less successful radiographically than [FC.sub.P] (COR3 = 0.43; s.e. = 0.34; CI = 0.22 - 0.83; p = 0.01).

Adjusted indirect comparisons for [MAT.sub.P] and [CH.sub.P] were calculated from 8 RCTs (5 + 3) comprising 531 molars (Table 6). Results indicated [MAT.sub.P] was significantly more likely (6.48 times) to produce clinical success than [CH.sub.P] (COR = 6.48; s.e. = 0.67; CI = 1.75 - 24.0; p = 0.005). Radiographically, [MAT.sub.P] was significantly more likely (10.47 times) to produce success than [CH.sub.P] (COR = 10.47; s.e. = 0.58; CI =3.35 - 32.76; p = 0.000).

[FIGURE 4 OMITTED]

Discussion

The EBD process identified 5 suitable RCTs for DMA to compare [MAT.sub.P] and [FC.sub.P], 12 RCTs for AMA to compare [MAT.sub.P] and [FS.sub.P], and 8 RCTs for AMA to compare [MAT.sub.P] and [CH.sub.P]. As statistical tests of heterogeneity deemed the clinical and radiographic data to be homogenous, fixed effects MA was a valid technique to estimate the common (pooled) treatment effect. A similar selection of studies was identified in a systematic review performing DMA on 6 RCTs to compare [MAT.sub.P] and [FC.sub.P] Peng et al., 2006]. Two RCTs were not included in the present MA since one was a preliminary report of the population reported in a later publication included for MA [Eidelman et al., 2001], and ORs could not be calculated for a second paper due to no failures in either group [Naik et al., 2005].

Individually, the 5 RCTs analysed by DMA in the present study showed no statistically significant differences in clinical and radiographic successes, but DMA of the pooled data showed the clinical (p = 0.03) and radiographic successes (p = 0.002) for [MAT.sub.P] were significantly higher than for [FC.sub.P]. The 95% CI for the CORs were narrower than the values for individual ORs, indicating higher precision for the COR value. Although findings from the 5 pooled RCTs were consistent, appearing generalizable across the study groups, the strength of the present analysis is limited by heterogeneity of the primary studies. While the randomization method was described in 3 of the RCTs, none concealed group allocations, allowing possible exaggeration of treatment effects [Schulz et al., 1995]. Different FC concentrations may have contributed to heterogeneity between studies. Assessor 'blinding' was reported in 4 of the RCTs and assessor calibration in 1 RCT, so outcome scoring may have differed between assessors in the same trial and between trials. Sample sizes ranged from 24 to 60 molars per group but no RCTs reported power calculations for sample size determination. Three RCTs accounted for all dropouts; high dropout rates can introduce bias as the impact of missing data is unknown.

Meta-analysis showed [MAT.sub.P] had significantly higher mean percentage clinical and radiographic success rates than and [CH.sub.P]. Due to a lack of comparability between subjects in different trials, AMA was used as supplementary evidence [Song et al., 2003]. Seven RCTs directly comparing [FS.sub.P] and [FC.sub.P] were subjected to meta-analysis, contributing to the adjusted indirect comparison for [MAT.sub.P] and [FS.sub.P]. No statistically significant difference was found in the clinical (p = 0.81) and radiographic successes (p = 0.84) for [FS.sub.P] and [FC.sub.P], confirming an earlier meta-analysis [Loh et al., 2004]. Adjusted indirect MA showed radiographic successes for [MAT.sub.P] were significantly higher than for [FS.sub.P] (p = 0.003). No statistically significant difference was found in the clinical successes for [MAT.sub.P] and [FS.sub.P] (p = 0.09), perhaps reflecting no true differences, or a sample size (959 molars) too small to detect a difference. As the lower 95% CI for COR was close to 1, a few additional trials could show a statistically significant difference. Even if a larger trial was conducted, there would be only a 2.5% chance an OR less than 0.84 would be found (95% certainty the true value is within the 95% CI). The wider 95% CI may explain why significant differences seen in NMA were now non-significant [Bucher et al., 1997; Song et al., 2002].

Three RCTs directly comparing [CH.sub.P] and [FC.sub.P] were subjected to meta-analysis, contributing to the adjusted indirect comparison for [MAT.sub.P] and [CH.sub.P]. This analysis found no statistically significant difference in the clinical successes for [CH.sub.P] and [FC.sub.P] (p = 0.07), which may reflect true similarity between the two medicaments, or a sample size (232 molars) too small to demonstrate a difference. As the upper 95% CI for COR was just over 1, a few additional studies could show a statistically significant difference. The radiographic successes for [CH.sub.P] were significantly less than for [FC.sub.P] (p = 0.01), although two studies included reporting on [CH.sub.P] showed radiographic evidence of intrapulpal calcifications and dentine bridges respectively [Waterhouse et al., 2000; Markovic et al., 2005].

Bridge formation represents the pulpal healing response and may not imply clinical success. Multiple tunnel defects in dentine bridges of mechanically-exposed pulps have been observed histologically, putatively allowing bacterial microleakage when exposed to the oral environment [Cox et al., 1996]. Radiographic failures of [CH.sub.P] molars were also reported as furcal and apical bony resorption, altered integrity of the lamina dura, and internal and external root resorption [Huth et al., 2005; Markovic et al., 2005]. Meta-analysis showed the clinical (p = 0.005) and radiographic successes (p = 0.000) for [MAT.sub.P] were significantly higher than for [CH.sub.P], perhaps reflecting the biocompatibility and pulpal regenerative abilities of MTA.

Although indirect comparisons suggest success rates for [MAT.sub.P] exceed those for [FS.sub.P] and [CH.sub.P], results must be interpreted cautiously as no RCTs directly compared [MAT.sub.P] with [FS.sub.P], or [MAT.sub.P] with [CH.sub.P]. The RCT is considered the highest level of evidence for clinical studies as randomization ensures baseline comparability between groups [Sutherland, 2001]. Wide confidence intervals suggest low precision [Song et al., 2003]. Pulpotomy outcomes are affected by therapeutic and host factors, including baseline pulpal status. In meta-analysis, comparability of primary studies is limited by clinical and methodological heterogeneity arising from differing inclusion criteria; differing diagnostic, pulpotomy and isolation techniques; and unequal exclusion of patients after randomisation. In the present study, results were pooled from papers regardless of study duration, biasing findings as pulpotomy success rates generally decline over time [Rolling et al., 1975]. Although primary molars may be required to function for up to 9 years before exfoliation, the length of follow-up for molars included in the present study ranged widely: up to 74 months for [MAT.sub.P] and [FC.sub.P], to 49.7 months for [FS.sub.P], and only 38.5 months for [CH.sub.P]. Of note, 2 RCTs with study durations of 24 months and up to 74 months respectively suggest MTA's ability to promote pulp healing and regeneration accounts for stable high success rates (no new failures) after 12 months [Farsi et al., 2005; Holan et al., 2005].

Although c2 and I2 tests of heterogeneity were performed in assembling studies, non-significant results may not indicate complete absence of heterogeneity [Higgins and Green, 2005]. Publication bias may also exist as the present study was limited to papers written in English and available online or through accessible libraries. Quality assessments were not performed in the present study. Meta-analyses pooling both high and low quality studies tend to be more supportive of an intervention than meta-analyses limited to high quality studies, so the lack of quality assessments could reduce the strength of the present findings [Schulz et al., 1995; Moher et al., 1998]. Further RCTs and MAs are needed to confirm the superiority of MTA as a pulpotomy medicament.

Answer to the PICOT question

The answer to the PICOT question is: (P) In human carious primary molars with reversible coronal pulpitis, (I) the use of MTA, (C) compared with FC, FS and CH, (O) resulted in significantly higher clinical and radiographic successes, (T) in all time periods up to exfoliation.

Conclusions

This series of evidence-based assessments of four pulpotomy medicaments for treatment of human carious primary molars with reversible coronal pulpitis draws three conclusions:

* In comparison with formocresol, ferric sulphate and calcium hydroxide, mineral trioxide aggregate resulted in significantly higher clinical and radiographic successes in all time periods up to exfoliation.

* Direct comparisons of mineral trioxide aggregate with ferric sulphate, and mineral trioxide aggregate with calcium hydroxide in randomized clinical trials were lacking.

* Mineral trioxide aggregate appears to be a superior pulpotomy medicament based on statistical analysis of the clinical and radiographic performance of four pulpotomy medicaments.

Acknowledgements

This study was supported by a grant from The University of Melbourne School of Dental Science Research Committee.

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F. K. Ng and L. B. Messer

Dept. Paediatric Dentistry, School of Dental Science, The University of Melbourne, Melbourne, Australia.

Postal address: Prof. L. Brearley Messer , Paediatric Dentistry, School of Dental Science, The University of Melbourne, 720 Swanston St, Carlton, Victoria 3010, Australia. Email: ljbm@unimelb.edu.au
Table 1: Chronological distribution of 5 papers examined by direct
meta-analysis comparing clinical and radiographic successes of
mineral trioxide aggregate and formocresol as primary molar
pulpotomy medicaments.

 Clinical data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Formocresol:
[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] * 36 35 (97)
[Holan et al., 2005] 29 24 (83)
Mean success rate (%)
 ([+ or -]SD) 90.8 [+ or -] 5.1
Subtotal teeth (% success) 147 134 (91)

Mineral trioxide aggregate:
[Cuisia et al., 2001] * 30 29 (97)
[Agamy et al., 2004] *
 ([double dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
Mean success rate (%)
 ([+ or -]SD) 97.6 [+ or -] 2.5
Subtotal teeth (% success) 152 148 (97)
Total teeth 299 282

 Radiographic data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Formocresol:
[Cuisia et al., 2001] * 30 23 (77)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] * 36 31 (86)
[Holan et al., 2005] 29 24 (83)
Mean success rate (%)
 ([+ or -]SD) 85.4 [+ or -] 5.7
Subtotal teeth (% success) 147 125 (85)

Mineral trioxide aggregate:
[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] *
 ([double dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
Mean success rate (%)
 ([+ or -]SD) 96.8 [+ or -] 3.3
Subtotal teeth (% success) 152 147 (97)
Total teeth 299 272

 Follow-up
Pulpotomy medicament period
and paper (months)

Formocresol:
[Cuisia et al., 2001] * 6
[Agamy et al., 2004] * 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([dagger])
Mean success rate (%)
 ([+ or -]SD)
Subtotal teeth (% success)

Mineral trioxide aggregate:
[Cuisia et al., 2001] * 6
[Agamy et al., 2004] *
 ([double dagger]) 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([dagger])
Mean success rate (%)
 ([+ or -]SD)
Subtotal teeth (% success)
Total teeth

* Percentage success rates derived from data reported in papers;
([dagger]) Teeth with less than 12 months follow-up were excluded from
this study unless a failure was detected during the first
post-operative year. One tooth failure in the formocresol group was
detected after 4 month; ([double dagger]) Data extracted from the
grey mineral trioxide aggregate group only.

Table 2. Chronological distribution of 28 papers examined by naive
indirect meta-analysis comparing clinical and radiographic
successes of mineral trioxide aggregate and formocresol as primary
molar pulpotomy medicaments.

 Clinical data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Formocresol:
[Redig, 1968] * 20 17 (85)
[Morawa et al., 1975] * 125 123 (98)
[Mejare, 1979] 29 17 (59)
[Alacam, 1989] 23 21 (91)
[Prakash et al., 1989] * 22 20 (91)
[Fei et al., 1991] 27 26 (96)
[Punwani and Fadavi, 1993] 40 34 (85)
[Roberts, 1996] * 142 141 (99)
[Aktoren and Gencay, 1997] 30 27 (90)
[Fuks, Holan et al., 1997] *
 ([dagger]) 37 31 (84)
[Aktoren and Gencay, 2000] 24 21 (88)
[Waterhouse et al., 2000] 44 37 (84)
[Cuisia et al., 2001] * 30 28 (93)
[Ram et al., 2001] * 16 16 (100)
[Dean et al., 2002] 25 25 (100)
[Papagiannoulis, 2002]
 ([double dagger]) 60 58 (97)
[Ibricevic and Al-Jame, 2003] 80 78 (97)
[Rivera et al., 2003] * 40 40 (100)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] 36 35 (97)
[Holan et al., 2005] 29 24 (83)
[Huth et al., 2005] 48 46 (96)
[Markovic et al., 2005] 33 30 (91)
[Naik and Hegde, 2005] 23 23 (100)
[Saltzman et al., 2005] * 24 24 (100)
Mean success rate (%)([+ or -]SD) 91.7 [+ or -] 8.8
Subtotal teeth (% success) 1,059 989 (93)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 5 5 (100)
[Cuisia et al., 2001] * 30 29 (97)
[Agamy et al., 2004] * [pi] 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
[Maroto et al., 2005] [yen] 20 20 (100)
[Naik and Hegde., 2005] 24 24 (100)
Mean success rate (%)([+ or -] SD) 98.5 [+ or -] 2.3
Subtotal teeth (% success) 201 197 (98)
Total teeth 1,260 1,186

 Radiographic data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Formocresol:
[Redig, 1968] * 20 17 (85)
[Morawa et al., 1975] * 125 123 (98)
[Mejare, 1979] 29 17 (59)
[Alacam, 1989] 23 19 (83)
[Prakash et al., 1989] * 22 20 (91)
[Fei et al., 1991] 27 22 (81)
[Punwani and Fadavi, 1993] 40 34 (85)
[Roberts, 1996] * 142 141 (99)
[Aktoren and Gencay, 1997] 30 25 (83)
[Fuks, Holan et al., 1997] *
 ([dagger]) 37 27 (73)
[Aktoren and Gencay, 2000] 24 19 (80)
[Waterhouse et al., 2000] 44 37 (84)
[Cuisia et al., 2001] * 30 23 (77)
[Ram et al., 2001] * 16 13 (81)
[Dean et al., 2002] 25 23 (92)
[Papagiannoulis, 2002]
 ([double dagger]) 60 47 (78)
[Ibricevic and Al-Jame, 2003] 80 75 (94)
[Rivera et al., 2003] * 40 37 (92)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] 36 31 (86)
[Holan et al., 2005] 29 24 (83)
[Huth et al., 2005] 48 43 (90)
[Markovic et al., 2005] 33 28 (85)
[Naik and Hegde, 2005] 23 23 (100)
[Saltzman et al., 2005] * 24 21 (87)
Mean success rate (%)([+ or -]SD) 85.7 [+ or -] 8.7
Subtotal teeth (% success) 1,059 936 (88)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 5 5 (100)
[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] * [pi] 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
[Maroto et al., 2005] [yen] 20 20 (100)
[Naik and Hegde., 2005] 24 24 (100)
Mean success rate (%)([+ or -] SD) 98.0 [+ or -] 3.0
Subtotal teeth (% success) 201 196 (98)
Total teeth 1,260 1,132

Pulpotomy medicament Follow-up
and paper period (months)

Formocresol:
[Redig, 1968] * 18
[Morawa et al., 1975] * To exfol
[Mejare, 1979] 12-30
[Alacam, 1989] 12
[Prakash et al., 1989] * 6
[Fei et al., 1991] 12
[Punwani and Fadavi, 1993] 12
[Roberts, 1996] * 6-91
[Aktoren and Gencay, 1997] 9
[Fuks, Holan et al., 1997] *
 ([dagger]) 6-34
[Aktoren and Gencay, 2000] 24
[Waterhouse et al., 2000] 1.3-38.5
[Cuisia et al., 2001] * 6
[Ram et al., 2001] * 6-17
[Dean et al., 2002] 5-25
[Papagiannoulis, 2002]
 ([double dagger]) 36
[Ibricevic and Al-Jame, 2003] 42-48
[Rivera et al., 2003] * 6
[Agamy et al., 2004] * 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] 24
[Holan et al., 2005] 4-74 ([section])
[Huth et al., 2005] 24
[Markovic et al., 2005] 18
[Naik and Hegde, 2005] 6
[Saltzman et al., 2005] * 12.7-18.7
Mean success rate (%)([+ or -]SD)
Subtotal teeth (% success)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 12
[Cuisia et al., 2001] * 6
[Agamy et al., 2004] * [pi] 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([section])
[Maroto et al., 2005] [yen] 6
[Naik and Hegde., 2005] 6
Mean success rate (%)([+ or -] SD)
Subtotal teeth (% success)
Total teeth

* Percentage success rates derived from data reported in papers;
([dagger]) Radiographic data extracted from findings at the last
recall examination where only molars with normal pulps were considered
radiographically successful; ([double dagger]) Radiographic data
extracted from percentage success rates reported in the paper;
reclassified data considering as failures only molars with progressive
or entensive internal resorption were not included; ([section]) Teeth
with less than 12 months follow-up were excluded from this study unless
a failure was detected during the first post-operative year. One tooth
failure in the formocresol group was detected after 4 months;
([pi]) Data extracted from the grey mineral trioxide aggregate group
only; ([yen]) Data extracted from primary molars only.

Table 3. Chronological distribution of 18 papers examined by
naive indirect meta-analysis comparing clinical and radiographic
successes of mineral trioxide aggregate and ferric sulphate as
primary molar pulpotomy medicaments.

 Clinical data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Ferric sulphate:
[Fei et al., 1991] 29 29 (100)
[Fuks, Holan et al., 1997] *
 ([dagger]) 55 51 (93)
[Aktoren and Gencay, 2000] 24 21 (88)
[Ram et al., 2001] * 14 13 (93)
[Papagiannoulis, 2002]
 ([double dagger]) 73 66 (90)
[Ibricevic and Al-Jame, 2003] 84 81 (96)
[Casas et al., 2004] * ([section]) -- --
[Huth et al., 2005] 49 49 (100)
[Markovic et al., 2005] 37 33 (89)
[Mohamed, 2006] 22 21 (95)
Mean success rate (%) ([+ or -] SD) 93.8 [+ or -] 4.4
Subtotal teeth (% success) 387 364 (94)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 5 5 (100)
[Cuisia et al., 2001] * 30 29 (97)
[Agamy et al., 2004] * ([pi]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
[Maroto et al., 2005] ([PHI]) 20 20 (100)
[Naik and Hegde, 2005] 24 24 (100)
Mean success rate (%) ([+ or -]SD) 98.5 [+ or -] 2.3
Subtotal teeth (% success) 201 197 (98)
Total teeth 588 561

 Radiographic data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Ferric sulphate:
[Fei et al., 1991] 29 28 (97)
[Fuks, Holan et al., 1997] *
 ([dagger]) 55 41 (75)
[Aktoren and Gencay, 2000] 24 20 (84)
[Ram et al., 2001] * 14 9 (64)
[Papagiannoulis, 2002]
 ([double dagger]) 73 54 (74)
[Ibricevic and Al-Jame, 2003] 84 77 992)
[Casas et al., 2004] * ([section]) 15 10 (67)
[Huth et al., 2005] 49 42 (86)
[Markovic et al., 2005] 37 30 (81)
[Mohamed, 2006] 22 18 (81)
Mean success rate (%) ([+ or -] SD) 80.1 [+ or -] 10.4
Subtotal teeth (% success) 402 329 (82)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 5 5 (100)
[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] * ([pi]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
[Maroto et al., 2005] ([PHI]) 20 20 (100)
[Naik and Hegde, 2005] 24 24 (100)
Mean success rate (%) ([+ or -]SD) 98.0 [+ or -] 3.0
Subtotal teeth (% success) 201 196 (98)
Total teeth 603 525

Pulpotomy medicament Follow-up period
and paper (months)

Ferric sulphate:
[Fei et al., 1991] 12
[Fuks, Holan et al., 1997] *
 ([dagger]) 6-34
[Aktoren and Gencay, 2000] 24
[Ram et al., 2001] * 6-17
[Papagiannoulis, 2002]
 ([double dagger]) 36
[Ibricevic and Al-Jame, 2003] 42-48
[Casas et al., 2004] * ([section]) 43.7-49.7
[Huth et al., 2005] 24
[Markovic et al., 2005] 18
[Mohamed, 2006] 6
Mean success rate (%) ([+ or -] SD)
Subtotal teeth (% success)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 12
[Cuisia et al., 2001] * 6
[Agamy et al., 2004] * ([pi]) 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 y
[Maroto et al., 2005] ([PHI]) 6
[Naik and Hegde, 2005] 6
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)
Total teeth

* Percentage success rates derived from data reported in papers;
([dagger]) Radiographic data extracted from findings at the last
recall examination where only molars with normal pulps were
considered radiographically successful;
([double dagger]) Radiographic data extracted from percentage success
rates reported in the paper; reclassified data considering as
failures only molars with progressive or extensive internal
resorption were not included; ([section]) Only molars classified as
having pathologic change recommended for immediate extraction were
considered radiographic failures; ([pi]) Data extracted from the grey
mineral trioxide aggregate group only; ([yen]) Teeth with less than
12 months follow-up were excluded from this study unless a failure was
detected during the first post-operative year. One tooth failure in
the formocresol group was detected after 4 months;
([PHI] Data extracted from primary molars only.

Table 4. Chronological distribution of 12 papers examined by adjusted
indirect meta-analysis comparing clinical and radiographic successes
of mineral trioxide aggregate, formocresol- and ferric sulphate as
primary molar pulpotomy medicaments.

 Clinical data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

5 papers directly comparing mineral trioxide
aggregate and ferric sulphate

Ferric sulphate:

[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] * 36 35 (97)
[Holan et al., 2005] 29 24 (83)
Mean success rate (%) ([+ or -]SD) 90.8 [+ or -] 5.1
Subtotal teeth (% success) 147 134 (91)

Mineral trioxide aggregate:

[Cuisia et al., 2001 ] * 30 29 (97)
[Agamy et al., 2004] *
 ([double dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
Mean success rate (%) ([+ or -]SD) 97.6 [+ or -] 2.5
Subtotal teeth (% success) 152 148 (97)
Total teeth 299 282

7 papers directly comparing ferric sulphate and formocresol

Formocresol:

[Fei et al., 1991] 27 26 (96)
[Fuks, Holan et al., 1997] *
 ([section]) 37 31 (84)
[Aktoren and Gencay, 2000] 24 21 (88)
[Papagiannoulis, 2002] ([pi]) 60 58 (97)
[Ibricevic and Al-Jame, 2003] 80 78 (97)
[Huth et al., 2005] 48 46 (96)
[Markovic et al., 2005] 33 30 (91)
Mean success rate (%)([+ or -]SD) 92.7 [+ or -] 5.2
Subtotal teeth (% success) 309 290 (94)
Ferric sulphate:
[Fei et al., 1991] 29 29 (100)
[Fuks, Holan et al., 1997] *
 ([section]) 55 51 (93)
[Aktoren and Gencay, 2000] 24 21 (88)
[Papagiannoulis, 2002] ([pi]) 73 66 (90)
[Ibricevic and Al-Jame, 2003] 84 81 (96)
[Huth et al., 2005] 49 49 (100)
[Markovic et al., 2005] 37 33 (89)
Mean success rate (%)([+ or -]SD) 93.7 [+ or -] 5.1
Subtotal teeth (% success) 351 330 (94)
Total teeth 660 620

 Radiographic data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

5 papers directly comparing mineral trioxide
aggregate and ferric sulphate

Ferric sulphate:

[Cuisia et al., 2001] * 30 23 (77)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] * 36 31 (86)
[Holan et al., 2005] 29 24 (83)
Mean success rate (%) ([+ or -]SD) 85.4 [+ or -] 5.7
Subtotal teeth (% success) 147 125 (85)

Mineral trioxide aggregate:

[Cuisia et al., 2001 ] * 30 28 (93)
[Agamy et al., 2004] *
 ([double dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
Mean success rate (%) ([+ or -]SD) 96.8 [+ or -] 3.3
Subtotal teeth (% success) 152 147 (97)
Total teeth 299 272

7 papers directly comparing ferric sulphate and formocresol

Formocresol:

[Fei et al., 1991] 27 22 (81)
[Fuks, Holan et al., 1997] *
 ([section]) 37 27 (73)
[Aktoren and Gencay, 2000] 24 19 (80)
[Papagiannoulis, 2002] ([pi]) 60 47 (78)
[Ibricevic and Al-Jame, 2003] 80 75 (94)
[Huth et al., 2005] 48 43 (90)
[Markovic et al., 2005] 33 28 (85)
Mean success rate (%)([+ or -]SD) 83.0 [+ or -] 7.2
Subtotal teeth (% success) 309 261 (84)
Ferric sulphate:
[Fei et al., 1991] 29 28 (97)
[Fuks, Holan et al., 1997] *
 ([section]) 55 41 (75)
[Aktoren and Gencay, 2000] 24 20 (84)
[Papagiannoulis, 2002] ([pi]) 73 54 (74)
[Ibricevic and Al-Jame, 2003] 84 77 (92)
[Huth et al., 2005] 49 42 (86)
[Markovic et al., 2005] 37 30 (81)
Mean success rate (%)([+ or -]SD) 84.1 [+ or -] 8.4
Subtotal teeth (% success) 351 292 (83)
Total teeth 660 553

Pulpotomy medicament Follow-up
and paper period (months)

5 papers directly comparing mineral trioxide
aggregate and ferric sulphate

Ferric sulphate:

[Cuisia et al., 2001] * 6
[Agamy et al., 2004] * 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([dagger])
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)

Mineral trioxide aggregate:

[Cuisia et al., 2001 ] * 6
[Agamy et al., 2004] *
 ([double dagger]) 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([dagger])
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)
Total teeth

7 papers directly comparing ferric
sulphate and formocresol

Formocresol:

[Fei et al., 1991] 12
[Fuks, Holan et al., 1997] *
 ([section]) 6-34
[Aktoren and Gencay, 2000] 24
[Papagiannoulis, 2002] ([pi]) 36
[Ibricevic and Al-Jame, 2003] 42-48
[Huth et al., 2005] 24
[Markovic et al., 2005] 18
Mean success rate (%)([+ or -]SD)
Subtotal teeth (% success)
Ferric sulphate:
[Fei et al., 1991] 12
[Fuks, Holan et al., 1997] *
 ([section]) 6-34
[Aktoren and Gencay, 2000] 24
[Papagiannoulis, 2002] ([pi]) 36
[Ibricevic and Al-Jame, 2003] 42-48
[Huth et al., 2005] 24
[Markovic et al., 2005] 18
Mean success rate (%)([+ or -]SD)
Subtotal teeth (% success)
Total teeth

* Percentage success rates derived from data reported in papers;
([dagger]) Teeth with less than 12 months follow-up were excluded
from this study unless a failure was detected; during the first
post-operative year. One tooth failure from the formocresol group
was detected after 4 months; ([double dagger]) Data extracted from
the grey mineral trioxide aggregate group only;
([section]) Radiographic data extracted from findings at the last
recall examination where only molars with normal pulps were
considered radiographically successful; [pi] Radiographic data
extracted from percentage success rates reported in the paper;
reclassified data considering as failures only molars with progressive
or extensive internal resorption were not included.

Table 5. Chronological distribution of 16 papers examined by naive
indirect meta-analysis comparing clinical and radiographic successes
of mineral trioxide aggregate and calcium hydroxide as primary molar
pulpotomy medicaments.

 Clinical data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Calcium hydroxide:
[Schroder, 1978] * 24 12 (50)
[Heilig et al., 1984] * 17 17 (100)
[Gruythuysen and Weerheijm, 1997] 92 74 (80)
[Rocha et al., 1999] * 9 8 (88)
[Waterhouse et al., 2000] 35 27 (77)
[Sasaki et al., 2002] 17 16 (94)
[Kalaskar and Damle, 2004] * 28 27 (96)
[Huth et al., 2005] 38 33 (87)
[Markovic et al., 2005] 34 28 (82)
Mean success rate (%) ([+ or -]SD) 83.8 [+ or -] 14.8
Subtotal teeth (% success) 294 242 (82)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 5 5 (100)
[Cuisia et al., 2001] * 30 29 (97)
[Agamy et al., 2004] * ([dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
[Maroto et al., 2005] ([section]) 20 20 (100)
[Naik and Hegde, 2005] 24 24 (100)
Mean success rate (%) ([+ or -]SD) 98.5 [+ or -] 2.3
Subtotal teeth (% success) 201 197 (98)
Total teeth 495 439

 Radiographic data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

Calcium hydroxide:
[Schroder, 1978] * 24 12 (50)
[Heilig et al., 1984] * 17 15 (88)
[Gruythuysen and Weerheijm, 1997] 92 74 (80)
[Rocha et al., 1999] * 9 8 (88)
[Waterhouse et al., 2000] 35 27 (77)
[Sasaki et al., 2002] 17 15 (88)
[Kalaskar and Damle, 2004] * 28 27 (96)
[Huth et al., 2005] 38 25 (66)
[Markovic et al., 2005] 34 26 (76)
Mean success rate (%) ([+ or -]SD) 78.8 [+ or -] 13.9
Subtotal teeth (% success) 294 229 (78)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 5 5 (100)
[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] * ([dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
[Maroto et al., 2005] ([section]) 20 20 (100)
[Naik and Hegde, 2005] 24 24 (100)
Mean success rate (%) ([+ or -]SD) 98.0 [+ or -] 3.0
Subtotal teeth (% success) 201 196 (98)
Total teeth 495 425

Pulpotomy medicament Follow-up
and paper period (months)

Calcium hydroxide:
[Schroder, 1978] * 24
[Heilig et al., 1984] * 9
[Gruythuysen and Weerheijm, 1997] 24
[Rocha et al., 1999] * 12
[Waterhouse et al., 2000] 1.3-38.5
[Sasaki et al., 2002] 6-34
[Kalaskar and Damle, 2004] * 6
[Huth et al., 2005] 24
[Markovic et al., 2005] 18
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)

Mineral Trioxide Aggregate:

[Rocha et al., 1999] * 12
[Cuisia et al., 2001] * 6
[Agamy et al., 2004] * ([dagger]) 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([double dagger])
[Maroto et al., 2005] ([section]) 6
[Naik and Hegde, 2005] 6
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)
Total teeth

* Percentage success rates derived from data reported in papers;
([dagger]) Data extracted from the grey mineral trioxide aggregate
group only; ([double dagger]) Teeth with less than 12 months
follow-up were excluded from this study unless a failure was
detected during the first post-operative year. One tooth failure
in the formocresol group was detected after 4 months;
([section]) Data extracted from primary molars only.

Table 6. Chronological distribution of 8 papers examined by adjusted
indirect meta-analysis comparing clinical and radiographic successes
of mineral trioxide aggregate, formocresol and calcium hydroxide as
primary molar pulpotomy medicaments.

 Clinical data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

5 papers directly comparing mineral trioxide aggregate and formocresol

Formocresol:
[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] * 36 35 (97)
[Holan et al., 2005] 29 24 (83)
Mean success rate (%) ([+ or -] SD) 90.8 [+ or -] 5.1
Subtotal teeth (% success) 147 134 (91)

Mineral trioxide aggregate:

[Cuisia et al., 2001] * 30 29 (97)
[Agamy et al., 2004] *
 ([double dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
Mean success rate (%) ([+ or -]SD) 97.6 [+ or -] 2.5
Subtotal teeth (% success) 152 148 (97)
Total teeth 299 282

3 papers directly comparing calcium hydroxide and formocresol

Formocresol:
[Waterhouse et al., 2000] 44 37 (84)
[Huth et al., 2005] 48 46 (96)
[Markovic et al., 2005] 33 30 (91)
Mean success rate (%) ([+ or -]SD) 90.3 [+ or -] 6.0
Subtotal teeth (% success) 125 113 (90)

Calcium hydroxide:
[Waterhouse et al., 2000] 35 27 (77)
[Huth et al., 2005] 38 33 (87)
[Markovic et al., 2005] 34 28 (82)
Mean success rate (%) ([+ or -]SD) 82.0 [+ or -] 5.0
Subtotal teeth (% success) 107 88 (82)
Total teeth 232 201

 Radiographic data

Pulpotomy medicament No. primary No. successful
and paper molars molars (%)

5 papers directly comparing mineral trioxide aggregate and formocresol

Formocresol:
[Cuisia et al., 2001] * 30 23 (77)
[Agamy et al., 2004] * 20 18 (90)
[Jabbarifar et al., 2004] 32 29 (91)
[Farsi et al., 2005] * 36 31 (86)
[Holan et al., 2005] 29 24 (83)
Mean success rate (%) ([+ or -] SD) 85.4 [+ or -] 5.7
Subtotal teeth (% success) 147 125 (85)

Mineral trioxide aggregate:

[Cuisia et al., 2001] * 30 28 (93)
[Agamy et al., 2004] *
 ([double dagger]) 19 19 (100)
[Jabbarifar et al., 2004] 32 30 (94)
[Farsi et al., 2005] * 38 38 (100)
[Holan et al., 2005] 33 32 (97)
Mean success rate (%) ([+ or -]SD) 96.8 [+ or -] 3.3
Subtotal teeth (% success) 152 147 (97)
Total teeth 299 272

3 papers directly comparing calcium hydroxide and formocresol

Formocresol:
[Waterhouse et al., 2000] 44 37 (84)
[Huth et al., 2005] 48 43 (90)
[Markovic et al., 2005] 33 28 (85)
Mean success rate (%) ([+ or -]SD) 86.3 [+ or -] 3.2
Subtotal teeth (% success) 125 108 (86)

Calcium hydroxide:
[Waterhouse et al., 2000] 35 27 (77)
[Huth et al., 2005] 38 25 (66)
[Markovic et al., 2005] 34 26 (76)
Mean success rate (%) ([+ or -]SD) 73.0 [+ or -] 6.1
Subtotal teeth (% success) 107 78 (73)
Total teeth 232 186

Pulpotomy medicament Follow-up
and paper period (months)

5 papers directly comparing mineral trioxide
aggregate and formocresol

Formocresol:
[Cuisia et al., 2001] * 6
[Agamy et al., 2004] * 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([dagger])
Mean success rate (%) ([+ or -] SD)
Subtotal teeth (% success)

Mineral trioxide aggregate:

[Cuisia et al., 2001] * 6
[Agamy et al., 2004] *
 ([double dagger]) 12
[Jabbarifar et al., 2004] 12
[Farsi et al., 2005] * 24
[Holan et al., 2005] 4-74 ([dagger])
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)
Total teeth

3 papers directly comparing calcium
hydroxide and formocresol

Formocresol:
[Waterhouse et al., 2000] 1.3-38.5
[Huth et al., 2005] 24
[Markovic et al., 2005] 18
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)

Calcium hydroxide:
[Waterhouse et al., 2000] 1.3-38.5
[Huth et al., 2005] 24
[Markovic et al., 2005] 18
Mean success rate (%) ([+ or -]SD)
Subtotal teeth (% success)
Total teeth

* Percentage success rates derived from data reported in papers;
([dagger]) Teeth with less than 12 months follow-up were excluded
from this study unless a failure was detected during the first
post-operative year. One tooth failure in the formocresol group
was detected after 4 months; ([double dagger]) Data extracted from
the grey mineral trioxide aggregate group only.
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Author:Ng, F.K.; Messer, L.B.
Publication:European Archives of Paediatric Dentistry
Geographic Code:8AUST
Date:Jun 1, 2008
Words:11562
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