Frédéric Courson

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

BackgroundSplit-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.MethodsWe 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.ResultsWe 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 (28 split-mouth and 28 parallel-arm RCTs). 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).ConclusionsOur 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.

Familial hypophosphatemic vitamin D–resistant rickets—prevention of spontaneous dental abscesses on primary teeth: A case report

Familial hypophosphatemic vitamin D-resistant rickets is a hereditary disease generally transmitted as an X-linked dominant trait and characterized by distinctive general clinical signs. Dental features include spontaneous dental abscesses that occur in the absence of a history of trauma or dental decay. The challenge for the dentist is to prevent and treat these lesions. This report describes the case of a young hypophosphatemic boy with abscesses. In this case, the application of fluid resin composites with a self-etching primer bonding system to all primary teeth prevented abscess formation for more than 1 year and thus avoided endodontic treatment or extraction. This constitutes a new approach to the prevention of spontaneous abscesses on primary teeth in children with familial hypophosphatemic rickets.

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.

Claudin-16 Deficiency Impairs Tight Junction Function in Ameloblasts, Leading to Abnormal Enamel Formation.

Claudin-16 protein (CLDN16) is a component of tight junctions (TJ) with a restrictive distribution so far demonstrated mainly in the kidney. Here, we demonstrate the expression of CLDN16 also in the tooth germ and show that claudin-16 gene (CLDN16) mutations result in amelogenesis imperfecta (AI) in the 5 studied patients with familial hypomagnesemia with hypercalciuria and nephrocalcinosis (FHHNC). To investigate the role of CLDN16 in tooth formation, we studied a murine model of FHHNC and showed that CLDN16 deficiency led to altered secretory ameloblast TJ structure, lowering of extracellular pH in the forming enamel matrix, and abnormal enamel matrix protein processing, resulting in an enamel phenotype closely resembling human AI. This study unravels an association of FHHNC owing to CLDN16 mutations with AI, which is directly related to the loss of function of CLDN16 during amelogenesis. Overall, this study indicates for the first time the importance of a TJ protein in tooth formation and underlines the need to establish a specific dental follow-up for these patients.

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

BackgroundTo 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.MethodsWe 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).ResultsWe 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.ConclusionsCochrane 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.

Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial

Introduction Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the computerised QuickSleeper system, in children and adolescents. Methods and analysis Inclusion criteria are patients 7–15 years old with at least 2 first permanent molars belonging to the same dental arch (for the split-mouth RCT) or with a first permanent molar (for the parallel-arm RCT) requiring conservative or endodontic treatment limited to pulpotomy. The setting of this study is the Department of Paediatric Dentistry at 3 University dental hospitals in France. The primary outcome measure will be pain reported by the patient on a visual analogue scale concerning the insertion of the needle and the injection/infiltration. Secondary outcomes are latency, need for additional anaesthesia during the treatment and pain felt during the treatment. We will use a computer-generated permuted-block randomisation sequence for allocation to anaesthesia groups. The random sequences will be stratified by centre (and by dental arch for the parallel-arm RCT). Only participants will be blinded to group assignment. Data will be analysed by the intent-to-treat principle. In all, 160 patients will be included (30 in the split-mouth RCT, 130 in the parallel-arm RCT). Ethics and dissemination This protocol has been approved by the French ethics committee for the protection of people (Comité de Protection des Personnes, Ile de France I) and will be conducted in full accordance with accepted ethical principles. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants. Trial registration number ClinicalTrials.gov NCT02084433.

Effectiveness of Resin-Based Sealants with and without Fluoride Placed in a High Caries Risk Population: Multicentric 2-Year Randomized Clinical Trial

A split-mouth randomized clinical trial was carried out to assess the effectiveness of sealants in preventing carious ICDAS (International Caries Detection and Assessment System) 3–6 lesions within a 2-year follow-up. We evaluated the effectiveness of 2 types of resin-based sealants, with and without fluoride, their retention rates, and the caries risk factors related to their outcomes. The study included 663 tooth pairs in 400 children (aged 5–15 years) considered to be at high individual caries risk (ICR) and presenting permanent molars free of caries or affected by ICDAS 1–2 lesions. In the first randomization, molars were either randomized to the treatment group receiving a dental sealant or the control group (nontreatment), and in the second randomization the sealant material to be used in the intervention group was selected. Uni- and multivariate Cox proportional hazard models were employed. At the 2-year follow-up, 483 tooth pairs were assessed: sealed molars had 83% (adjusted HR = 0.17; 95% CI: 0.15–0.20) less risk of developing ICDAS 3–6 lesions than molars without sealant. The magnitude of the protective effect was lower among teeth with ICDAS 1–2 lesions or with occlusal deep fissures than without. If the total retention rate of sealants was 70% at 2 years, sealant loss was not associated with the risk of caries (HR = 1.29, 95% CI: 0.92–1.79, p = 0.14). Sealants allow the prevention of new ICDAS 3–6 lesions or progression of noncavitated carious lesions in children at high ICR, and the effect of the sealant was similar regardless of whether it contained fluoride or not.

Management of non-syndromic double tooth affecting permanent maxillary central incisors: a systematic review

To assess management of non-syndromic double tooth affecting permanent maxillary central incisors, we performed a systematic review and also present 2 case reports. We searched MEDLINE via PubMed and the reference lists of included reports. Eligible studies were any type of clinical studies describing the management of non-syndromic double tooth affecting the crown of a permanent maxillary central incisor. We included 68 studies corresponding to 72 relevant case reports. Therapeutic options in descending order of priority were restorative dentistry (35%), hemisection (33%), abstention (17%) or extraction (15%). Orthodontic management resulted in 57% of cases. We report an 11-year-old boy with bilateral fusion of the two maxillary central incisors and a 9-year-old boy with a double left central incisor and a supernumerary lateral right incisor. A multidisciplinary approach is key to management of permanent maxillary central incisors affected by coronary anomalies.

Management of non-syndromic dens evaginatus affecting permanent maxillary central incisors: a systematic review.

To assess management of non-syndromic dens evaginatus affecting permanent maxillary central incisor, we performed a systematic review and also present a case report. We searched PubMed via MEDLINE and the reference lists of included reports. Eligible studies were any type of clinical studies describing the management of non-syndromic dens evaginatus affecting the crown of a permanent maxillary central incisor. We included 31 studies corresponding to 34 relevant case reports. Therapeutic options were complete reduction of the talon cusp in a single appointment (56%), periodic and gradual reduction of the cusp (26%), abstention (13%) or extraction (5%). We report an 8-year-old girl with unusual two-talon cusp, labial and lingual, on a right maxillary double central incisor. A multidisciplinary approach is key to management of permanent maxillary central incisors affected by coronary anomalies.

Assessment and management of chronic orofacial pain associated with a disease in children: a multidisciplinary approach

To summarize the diversity of assessment and management for chronic orofacial pain associated with a disease (COFPAD) in children. We performed a review of the literature up to May 2012. Hetero‐evaluation and self‐assessment are used according to age of children. Strict management of the cause is not sufficient for children with COFPAD without a multidisciplinary approach combining pharmacotherapy, psychology and physiotherapy.