Pulp treatment for extensive decay in primary teeth.

BACKGROUND: In children, dental caries (tooth decay) is among the most prevalent chronic diseases worldwide. Pulp interventions are indicated for extensive tooth decay. Depending on the severity of the disease, three pulp treatment techniques are available: direct pulp capping, pulpotomy and pulpectomy. After treatment, the cavity is filled with a medicament. Materials commonly used include mineral trioxide aggregate (MTA), calcium hydroxide, formocresol or ferric sulphate.This is an update of a Cochrane Review published in 2014 when insufficient evidence was found to clearly identify one superior pulpotomy medicament and technique. OBJECTIVES: To assess the effects of different pulp treatment techniques and associated medicaments for the treatment of extensive decay in primary teeth. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the Cochrane Oral Health Group's Trials Register (to 10 August 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2017, Issue 7), MEDLINE Ovid (1946 to 10 August 2017), Embase Ovid (1980 to 10 August 2017) and the Web of Science (1945 to 10 August 2017). OpenGrey was searched for grey literature. The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing interventions that combined a pulp treatment technique with a medicament or device in children with extensive decay in the dental pulp of their primary teeth. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed 'Risk of bias'. We contacted authors of RCTs for additional information when necessary. The primary outcomes were clinical failure and radiological failure, as defined in trials, at six, 12 and 24 months. We performed data synthesis with pair-wise meta-analyses using fixed-effect models. We assessed statistical heterogeneity by using I² coefficients. MAIN RESULTS: We included 40 new trials bringing the total to 87 included trials (7140 randomised teeth) for this update. All were small, single-centre trials (median number of randomised teeth = 68). All trials were assessed at unclear or high risk of bias.The 87 trials examined 125 different comparisons: 75 comparisons of different medicaments or techniques for pulpotomy; 25 comparisons of different medicaments for pulpectomy; four comparisons of pulpotomy and pulpectomy; and 21 comparisons of different medicaments for direct pulp capping.The proportion of clinical failures and radiological failures was low in all trials. In many trials, there were either no clinical failures or no radiographic failures in either study arm.For pulpotomy, we assessed three comparisons as providing moderate-quality evidence. Compared with formocresol, MTA reduced both clinical and radiological failures, with a statistically significant difference at 12 months for clinical failure and at six, 12 and 24 months for radiological failure (12 trials, 740 participants). Compared with calcium hydroxide, MTA reduced both clinical and radiological failures, with statistically significant differences for clinical failure at 12 and 24 months. MTA also appeared to reduce radiological failure at six, 12 and 24 months (four trials, 150 participants) (low-quality evidence). When comparing calcium hydroxide with formocresol, there was a statistically significant difference in favour of formocresol for clinical failure at six and 12 months and radiological failure at six, 12 and 24 months (six trials (one with no failures), 332 participants).Regarding pulpectomy, we found moderate-quality evidence for two comparisons. The comparison between Metapex and zinc oxide and eugenol (ZOE) paste was inconclusive, with no clear evidence of a difference between the interventions for failure at 6 or 12 months (two trials, 62 participants). Similarly inconclusive, there was no clear evidence of a difference in failure between Endoflas and ZOE (outcomes measured at 6 months; two trials, 80 participants). There was low-quality evidence of a difference in failure at 12 months that suggested ZOE paste may be better than Vitapex (calcium hydroxide/iodoform) paste (two trials, 161 participants).Regarding direct pulp capping, the small number of studies undertaking the same comparison limits any interpretation. We assessed the quality of the evidence as low or very low for all comparisons. One trial appeared to favour formocresol over calcium hydroxide; however, there are safety concerns about formocresol. AUTHORS' CONCLUSIONS: Pulp treatment for extensive decay in primary teeth is generally successful. Many included trials had no clinical or radiological failures in either trial arm, and the overall proportion of failures was low. Any future trials in this area would require a very large sample size and follow up of a minimum of one year.The evidence suggests MTA may be the most efficacious medicament to heal the root pulp after pulpotomy of a deciduous tooth. As MTA is relatively expensive, future research could be undertaken to confirm if Biodentine, enamel matrix derivative, laser treatment or Ankaferd Blood Stopper are acceptable second choices, and whether, where none of these treatments can be used, application of sodium hypochlorite is the safest option. Formocresol, though effective, has known concerns about toxicity.Regarding pulpectomy, there is no conclusive evidence that one medicament or technique is superior to another, and so the choice of medicament remains at the clinician's discretion. Research could be undertaken to confirm if ZOE paste is more effective than Vitapex and to evaluate other alternatives.Regarding direct pulp capping, the small number of studies and low quality of the evidence limited interpretation. Formocresol may be more successful than calcium hydroxide; however, given its toxicity, any future research should focus on alternatives.

Bisphenol A Release: Survey of the Composition of Dental Composite Resins.

BACKGROUND: Bisphenol A (BPA) is an endocrine disruptor with potential toxicity. Composite resins may not contain pure BPA, but its derivatives are widely used. Several studies found doses of BPA or its derivatives in saliva or urine of patients after composite resin placement. OBJECTIVE: The aims of this study were to establish an exhaustive list of composite resins marketed in Europe and their composition, and to assess the extent of BPA derivatives used. METHODS: A research on manufacturers' websites was performed to reference all composite resins marketed in Europe, then their composition was determined from both material safety data sheets and a standardized questionnaire sent to manufacturers. Manufacturers had to indicate whether their product contained the monomers listed, add other monomers if necessary, or indicate "not disclosed". RESULTS: 160 composite resins were identified from 31 manufacturers and 23 manufacturers (74.2%) responded to the survey. From the survey and websites, the composition of 130 composite resins (81.2%) was: 112 (86.2%) based on BPA derivatives, 97 (74.7%) on bis-GMA, 17 (13.1%) without monomer derived from BPA (UDMA, sometimes with TEGDMA) and 6 (4.6%) with UDMA (only); 1 (0.8%) did not contain a BPA derivative or UDMA or TEGDMA. Pure BPA was never reported. CONCLUSION: This work has established a list of 18 composite resins that contain no BPA derivative. Manufacturers should be required to report the exact composition of their products as it often remains unclear or incomplete.

One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial.

BACKGROUND: Current concepts in conservative dentistry advocate minimally invasive dentistry and pulp vitality preservation. Moreover, complete removal of carious dentin in deep carious lesions often leads to pulp exposure and root canal treatment, despite the absence of irreversible pulp inflammation. For years, partial caries removal has been performed on primary teeth, but little evidence supports its effectiveness for permanent teeth. Furthermore, the recent development of new antibacterial adhesive systems could be interesting in the treatment of such lesions. The objectives of this study are to compare the effectiveness of partial versus complete carious dentin removal in deep lesions (primary objective) and the use of an antibacterial versus a traditional two-step self-etch adhesive system (main secondary objective). METHODS/DESIGN: The DEep CAries Treatment (DECAT) study protocol is a multicenter, randomized, controlled superiority trial comparing partial versus complete caries removal followed by adhesive restoration. The minimum sample size required is 464 patients. Two successive randomizations will be performed (allocation ratio 1:1): the first for the type of excavation (partial versus complete) and the second (if no root canal treatment is required) for the type of adhesive (antibacterial versus traditional). For the two objectives, the outcome is the success of the treatment after 1 year, measured according to a composite outcome of five FDI criteria: material fracture and retention, marginal adaptation, radiographic examination (including apical pathologies), postoperative sensitivity and tooth vitality, and carious lesion recurrence. DISCUSSION: The study will investigate the interest of a conservative approach for the management of deep carious lesions in terms of dentin excavation and bioactive adhesive systems. The results may help practitioners achieve the most efficient restorative procedure to maintain pulp vitality and increase the restoration longevity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02286388 . Registered in November 2014.

Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.

BACKGROUND: Bone preservation is an essential issue in the context of last teeth extraction and complete edentulism. The intended treatment, whether a complete denture or an implant placement, is facilitated with a voluminous residual ridge. Bone resorption after multiple extractions has not been as well studied as the bone resorption that occurs after the extraction of a single tooth. Recent advances in bone substitute materials have revived this issue. The purpose of this study is to evaluate the interest in using bone substitute material to fill the socket after last teeth extraction in a maxillary immediate complete denture procedure compared with the conventional protocol without socket filling. METHODS/DESIGN: A randomized, controlled, clinical trial was designed. The 34 participants eligible for maxillary immediate complete denture were divided into two groups. Complete dentures were prepared despite persistence of the last anterior teeth. The control group received a conventional treatment including denture placement immediately after extractions. In the experimental group, in addition to the immediate denture placement, a xenograft bone-substitute material (Bio-Oss Collagen®) was placed in the fresh sockets. The primary outcome of the study is to compare mean bone ridge height loss 1 year after maxillary immediate complete denture placement, with or without bone-substitute material, in incisor and canine sockets. The secondary outcomes are to compare the average bone ridge height and width loss for each extraction site. An original quantitative evaluation method using cone beam computed tomography was designed for reproducible measurements, with a radio-opaque denture duplicate. Two independent operators perform the radiologic measurements. DISCUSSION: The immediate complete denture technique limits bone resorption in multiple extraction situations and thus allows better denture retention and better options for implant placement. To compare the benefit of using any bone socket-filling material, we proposed a quantitative evaluation protocol of resorption in the specific case of the last anterior maxillary teeth extraction with immediate denture placement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02120053 . Registered on 18 April 2014.

Understanding dental CAD/CAM for restorations--accuracy from a mechanical engineering viewpoint.

As is the case in the field of medicine, as well as in most areas of daily life, digital technology is increasingly being introduced into dental practice. Computer-aided design/ computer-aided manufacturing (CAD/CAM) solutions are available not only for chairside practice but also for creating inlays, crowns, fixed partial dentures (FPDs), implant abutments, and other dental prostheses. CAD/CAM dental practice can be considered as the handling of devices and software processing for the almost automatic design and creation of dental restorations. However, dentists who want to use dental CAD/CAM systems often do not have enough information to understand the variations offered by such technology practice. Knowledge of the random and systematic errors in accuracy with CAD/CAM systems can help to achieve successful restorations with this technology, and help with the purchasing of a CAD/CAM system that meets the clinical needs of restoration. This article provides a mechanical engineering viewpoint of the accuracy of CAD/ CAM systems, to help dentists understand the impact of this technology on restoration accuracy.

Pulp treatment for extensive decay in primary teeth.

BACKGROUND: In children, dental caries is among the most prevalent chronic diseases worldwide. Pulp interventions are indicated for extensive tooth decay. Depending on the severity of the disease, three pulp treatment techniques are available: direct pulp capping, pulpotomy and pulpectomy. After treatment, the cavity is filled with a medicament.This is an update of a Cochrane review first published in 2003. The previous review found insufficient evidence regarding the relative efficacy of these interventions, combining one pulp treatment technique and one medicament. OBJECTIVES: To assess the effects of different pulp treatment techniques and associated medicaments for the treatment of extensive decay in primary teeth. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 25 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), MEDLINE via OVID (1946 to 25 October 2013), EMBASE via OVID (1980 to 25 October 2013) and the Web of Science (1945 to 25 October 2013). We searched OpenGrey for grey literature and the US National Institutes of Health Trials Register and the World Health Organization (WHO) Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Eligible studies were randomised controlled trials comparing different pulp interventions combining a pulp treatment technique and a medicament in children with extensive decay involving dental pulp in primary teeth. DATA COLLECTION AND ANALYSIS: Two review authors independently carried out data extraction and risk of bias assessment in duplicate. We contacted authors of randomised controlled trials for additional information if necessary. The primary outcomes were clinical failure and radiological failure, as defined in trials, at six, 12 and 24 months. We performed data synthesis with pairwise meta-analyses using fixed-effect models. We assessed statistical heterogeneity using by I(2) coefficients. MAIN RESULTS: We included 47 trials (3910 randomised teeth) compared to three trials in the previous version of the review published in 2003. All trials were single centre and small sized (median number of randomised teeth 68). Overall, the risk of bias was low in only one trial with all other trials being at unclear or high risk of bias. The overall quality of the evidence was low. The 47 trials examined 53 different comparisons: 25 comparisons between different medicaments/techniques for pulpotomy, 13 comparisons between different medicaments for pulpectomy, 13 comparisons between different medicaments for direct pulp capping and two comparisons between pulpotomy and pulpectomy. Regarding pulpotomy, 14 trials compared mineral trioxide aggregate (MTA) with formocresol (FC). MTA reduced both clinical and radiological failures at six, 12 and 24 months, although the difference was not statistically significant. MTA also showed favourable results for all secondary outcomes measured, although again, differences between MTA and FC were not statistically significant (with the exception of pathological root resorption at 24 months and dentine bridge formation at six months). MTA showed favourable results compared with calcium hydroxide (CH) (two trials) for all outcomes measured, but the differences were not statistically significant (with the exception of radiological failure at 12 months). When comparing MTA with ferric sulphate (FS) (three trials), MTA had statistically significantly fewer clinical, radiological and overall failures at 24 months. This difference was not shown at six or 12 months.FC was compared with CH in seven trials and with FS in seven trials. There was a statistically significant difference in favour of FC for clinical failure at six and 12 months, and radiological failure at six, 12 and 24 months. FC also showed favourable results for all secondary outcomes measured, although differences between FC and CH were not consistently statistically significant across time points. The comparisons between FC and FS showed no statistically significantly difference between the two medicaments for any outcome at any time point.For all other comparisons of medicaments used during pulpotomies, pulpectomies or direct pulp capping, the small numbers of studies and the inconsistency in results limits any interpretation. AUTHORS' CONCLUSIONS: We found no evidence to identify one superior pulpotomy medicament and technique clearly. Two medicaments may be preferable: MTA or FS. The cost of MTA may preclude its clinical use and therefore FS could be used in such situations. Regarding other comparisons for pulpectomies or direct pulp capping, the small numbers of studies undertaking the same comparison limits any interpretation.

Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study.

BACKGROUND: Split-mouth randomized controlled trials (RCTs) are popular in oral health research. Meta-analyses frequently include trials of both split-mouth and parallel-arm designs to derive combined intervention effects. However, carry-over effects may induce bias in split- mouth RCTs. We aimed to assess whether intervention effect estimates differ between split- mouth and parallel-arm RCTs investigating the same questions. METHODS: We performed a meta-epidemiological study. We systematically reviewed meta- analyses including both split-mouth and parallel-arm RCTs with binary or continuous outcomes published up to February 2013. Two independent authors selected studies and extracted data. We used a two-step approach to quantify the differences between split-mouth and parallel-arm RCTs: for each meta-analysis. First, we derived ratios of odds ratios (ROR) for dichotomous data and differences in standardized mean differences (∆SMD) for continuous data; second, we pooled RORs or ∆SMDs across meta-analyses by random-effects meta-analysis models. RESULTS: We selected 18 systematic reviews, for 15 meta-analyses with binary outcomes (28 split-mouth and 28 parallel-arm RCTs) and 19 meta-analyses with continuous outcomes (45 split-mouth and 48 parallel-arm RCTs). [corrected]. Effect estimates did not differ between split-mouth and parallel-arm RCTs (mean ROR, 0.96, 95% confidence interval 0.52-1.80; mean ∆SMD, 0.08, -0.14-0.30). CONCLUSIONS: Our study did not provide sufficient evidence for a difference in intervention effect estimates derived from split-mouth and parallel-arm RCTs. Authors should consider including split-mouth RCTs in their meta-analyses with suitable and appropriate analysis.

Methodological quality and implications for practice of systematic Cochrane reviews in pediatric oral health: a critical assessment.

BACKGROUND: To ensure evidence-based decision-making in pediatric oral health, Cochrane systematic reviews that address topics pertinent to this field are necessary. We aimed to identify all systematic reviews of paediatric dentistry and oral health by the Cochrane Oral Health Group (COHG), summarize their characteristics and assess their methodological quality. Our second objective was to assess implications for practice in the review conclusions and provide an overview of clinical implications about the usefulness of paediatric oral health interventions in practice. METHODS: We conducted a methodological survey including all paediatric dentistry reviews from the COHG. We extracted data on characteristics of included reviews, then assessed the methodological quality using a validated 11-item quality assessment tool (AMSTAR). Finally, we coded each review to indicate whether its authors concluded that an intervention should be implemented in practice, was not supported or was refuted by the evidence, or should be used only in research (inconclusive evidence). RESULTS: We selected 37 reviews; most concerned the prevention of caries. The methodological quality was high, except for the assessment of reporting bias. In 7 reviews (19%), the research showed that benefits outweighed harms; in 1, the experimental intervention was found ineffective; and in 29 (78%), evidence was insufficient to assess benefits and harms. In the 7 reviews, topical fluoride treatments (with toothpaste, gel or varnish) were found effective for permanent and deciduous teeth in children and adolescents, and sealants for occlusal tooth surfaces of permanent molars. CONCLUSIONS: Cochrane reviews of paediatric dentistry were of high quality. They provided strong evidence that topical fluoride treatments and sealants are effective for children and adolescents and thus should be implemented in practice. However, a substantial number of reviews yielded inconclusive evidence.

Laypersons' esthetic perception of various computer-generated diastemas: a pilot study.

STATEMENT OF PROBLEM: Managing excess anterior spacing is a common problem in dental practice. During orthodontic or restorative treatment planning, clinicians must decide how to distribute this space. However, few reports are available in the dental literature about the attractiveness and esthetic impact of anterior spaces other than midline diastemas. PURPOSE: The purpose of this study was to compare the esthetic perception of 4 different anterior diastemas, including simian diastemas (symmetrical diastemas between lateral incisor and canine), diastemas suggested by Frush and Fisher (asymmetrical diastemas between lateral incisor and canine and between central and lateral incisor), and by Lombardi (slight midline diastema and 2 larger diastemas between central and lateral incisors), and a midline diastema. MATERIAL AND METHODS: A picture of a young woman's smiling face was modified by using photoediting software to create the 4 previously mentioned diastemas. The resulting pictures were presented to laypersons questioned in French public places. The participants were asked to rank the pictures from most to least attractive, then to rate them with a mark from 1 to 10. RESULTS: One hundred and five participants completed the questionnaire. The median ranks and scores attributed to the pictures from most to least attractive were as follows: simian diastemas, 1 and 8; Frush and Fisher diastemas, 2 and 7; Lombardi diastemas, 3 and 5; and midline diastemas, 4 and 4, respectively. The hierarchy (simian diastemas>Frush and Fisher diastemas>Lombardi diastemas>midline diastemas) could be established statistically for the scores (P=.03, P<.001, and P<.001, respectively) but not for the ranks when adjusting on subjects' sex and age (P=.11, P=.03, and P=.06, respectively). CONCLUSIONS: The results showed an esthetic hierarchy of anterior diastemas. The negative perception of anterior diastemas seems to mainly be related to the presence and width of a midline diastema. These results can guide clinical decisions for patients with excess anterior spacing.

Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

OBJECTIVES: Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. MATERIALS AND METHODS: The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. RESULTS: Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. CONCLUSIONS: A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. CLINICAL RELEVANCE: This software will help investigators choose the appropriate randomization method in future two-arm trials.

Clinical efficacy of composite versus ceramic inlays and onlays: a systematic review.

OBJECTIVES: Large tooth substance losses are frequent in posterior teeth because of primary caries or aging restorations. Inlays and onlays are often the minimal invasive solution in such cases, but the efficacy of the composite and ceramic materials used is unknown. We performed a systematic review of randomized controlled trials comparing the efficacy of composite and ceramic inlays or onlays. DATA SOURCES: MEDLINE, Embase and the Cochrane Central Register of Controlled Trials were searched without any restriction on date or language, as were references of eligible studies and ClinicalTrials.gov. STUDY SELECTION: Eligible studies were randomized trials comparing the clinical efficacy of composite to ceramic inlays or onlays in adults with any clinical outcome for at least 6 months. From 172 records identified, we examined reports of 2 randomized controlled trials involving 138 inlays (no onlays evaluated) in 80 patients and exhibiting a high-risk of bias. Outcomes were clinical scores and major failures. The 3-year overall failure risk ratio was 2 [0.38-10.55] in favor of ceramic inlays although not statistically significant. The reported clinical scores (United States Public Health Services and Californian Dental Association) showed considerable heterogeneity between trials and could not be combined. CONCLUSIONS: We have very limited evidence that ceramics perform better than composite material for inlays in the short term. However, this result may not be valid in the long term, and other trials are needed. Trials should follow Fédération dentaire internationale recommendations and enhance their methodology. Trials comparing composite and ceramic onlays are needed.

Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial.

BACKGROUND: Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis. METHODS: The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument's items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials. DISCUSSION: For clinicians, the CECOIA trial results may help with evidence-based recommendations concerning the choice of materials for inlay/onlay restoration. For patients, the results may lead to improvement in long-term restoration. For researchers, the results may provide ideas for further research concerning inlay/onlay materials and prognosis.This trial is funded by a grant from the French Ministry of Health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01724827.

Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children.

OBJECTIVES: Evidence-based comparisons of interventions can be challenging because of the diversity of outcomes in randomized controlled trials (RCTs). We aimed to describe outcomes in RCTs assessing pulp treatments for primary teeth and to develop a core set of component outcomes to be part of composite outcome defining the failure of a pulp treatment. METHODS: We systematically reviewed articles of RCTs comparing pulp treatments for primary molars published up to February 2012. We abstracted all outcomes assessed in each trial, then used a small-group consensus process to group similar outcomes, which were reduced to a composite outcome of failure of a pulp treatment by a 3-round Delphi process involving expert authors and dentists. RESULTS: We included 47 reports of RCTs in the review, for 83 reported outcomes (median 11 outcomes per RCT). These outcomes were grouped into 24 overarching outcome categories. We contacted 210 experts for the Delphi process and 25% to 30% participated. The process identified the following 5 component outcomes as part of a composite outcome of failure of a pulp treatment: soft-tissue pathology, pain, pathologic mobility, pathologic radiolucency and pathologic root resorption. CONCLUSIONS: RCTs of pulp treatments for primary teeth investigate diverse outcomes. Our consensus process, involving clinicians but no patient, allowed for compiling a core set of component outcomes to define the composite outcome failure of a pulp treatment for primary teeth.