Abstract
ObjectivesEvidence-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.MethodsWe 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.ResultsWe 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.ConclusionsRCTs 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.
Highlights
In children, extensive tooth decay is the most common disease of primary teeth; 42% of children aged 2 to 11 have dental caries in their primary teeth, with an average of 1.6 decayed teeth per child [1]
We systematically reviewed randomized controlled trials (RCTs) assessing the effectiveness of pulp treatment techniques in primary molars to identify the diversity of outcomes in general and component outcomes that were part of a composite outcome defining the success or failure of a pulp treatment
Our systematic review of 47 reports of RCTs assessing the effectiveness of pulp treatments in primary teeth revealed great diversity in outcomes, the component outcomes of a composite outcome defining success or failure of a pulp treatment
Summary
Extensive tooth decay is the most common disease of primary teeth; 42% of children aged 2 to 11 have dental caries in their primary teeth, with an average of 1.6 decayed teeth per child [1]. Depending on the severity of the disease, 3 pulp treatments are available: direct pulp capping, pulpotomy and pulpectomy [2]. A large number of biomaterials are available to fill the cavity after treatment. The efficacy of these interventions, combining 1 pulp treatment and 1 biomaterial, needs assessment and many randomized controlled trials (RCTs) have been conducted to compare interventions. Consensus is lacking regarding the most relevant outcomes, especially for the definition of success or failure. All these outcomes are frequently assessed at different times within and across trials
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