Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

BACKGROUND: Preliminary clinical studies on the single-implant mandibular overdenture (SIMO) have reported favorable results as an alternative to the conventional complete dentures for rehabilitation of the edentulous mandible. Clinical and patient-reported outcomes were assessed but no evidence is available with respect to the cost-effectiveness of this treatment, which is particularly important to test whether the incremental cost associated with the implant treatment is justified facing the benefits from the intervention. Thus, the aim of this study is to assess the cost-effectiveness of single-implant mandibular overdentures. METHODS/DESIGN: This randomized clinical trial will include edentulous individuals who meet eligibility criteria. Participants will be randomized into one of the treatment groups: a conventional complete denture group or a single-implant mandibular overdenture group. Direct costs related to therapies in both groups will be identified, measured and valuated for 1 year after treatment. Oral health-related quality of life and satisfaction with the dentures will be the primary outcome variables. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model. DISCUSSION: This is the first trial-based cost-effectiveness study on single-implant mandibular overdentures. Specific challenges in designing the protocol are considered. The expected results are of high clinical relevance and may contribute to the decision-making process when choosing between different alternatives for the rehabilitation of the edentulous mandible. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02710357, registered on 11 March 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1646-0) contains supplementary material, which is available to authorized users.