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

ABSTRACT: 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.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.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.ClinicalTrials.gov Identifier: NCT02710357 , registered on 11 March 2016.

SUBMITTER: Nogueira TE

PROVIDER: S-EPMC5097429 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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

Nogueira Túlio Eduardo TE Esfandiari Shahrokh S Leles Cláudio Rodrigues CR

Trials 20161104 1

<h4>Background</h4>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 facin ...[more]

PMID: 27814749

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Project description:ObjectivesSingle denture rehabilitated patients have negative appraisals regarding oral function, mostly associated by stability and retention issues regarding mandibular prosthetics. Therefore, this study assessed patients' occlusal equilibration, muscle activity, and oral health-related quality of life (OHRQoL) receiving milled removable or fixed mandibular implant retained prostheses.Materials and methodsTwenty-two edentulous mandibular ridges patients were randomly distributed into two groups based on the definitive prosthesis received. Group I: Removable mandibular implant-supported overdenture, Group II: Implant retained fixed prosthesis. Occlusal equilibration was evaluated utilizing Occlusense, muscle activity via Electromyograph (EMG) at delivery, after one, and three months. The OHRQoL was evaluated by Oral Health Impact Profile questionnaire (OHIP-19) before delivery and after follow-ups. Data were collected, tabulated, and analyzed, utilizing independent t-test and One-way ANOVA followed Tukey`s post-hoc test. Significance level set at P ≤ 0.05.ResultsGroups I &II showed significant improvement in occlusal equilibration, muscle activity and OHRQoL. Group II demonstrated significantly higher improvement than group I in occlusal equilibration associated with muscle activity after 1 month, and in functional limitations domain in OHRQoL questionnaire after 3 months.ConclusionImplant retained mandibular prosthesis showed improvement in occlusal equilibration, muscle activity, and OHRQoL regardless of prosthesis type employed. Fixed implant-supported prosthesis revealed better outcomes than removable mandibular implant-supported overdenture concerning occlusal equilibration, muscle activity, and OHRQoL regarding functional limitations.Clinical relevanceImplant retained mandibular prosthesis is one of best treatment options for single mandibular completely edentulous patients, as dental implants improved occlusal equilibration, muscle activity, and OHRQoL.

Project description:To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate, posterior, and panuveitis.Randomized, controlled, clinical trial.Patients with active or recently active intermediate, posterior, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment Trial.Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals. Analyses were stratified by disease laterality at randomization (31 unilateral vs 224 bilateral) because of the large upfront cost of the implant.The primary outcome was the incremental cost-effectiveness ratio (ICER) over 3 years: the ratio of the difference in cost (in United States dollars) to the difference in quality-adjusted life-years (QALYs). Costs of medications, surgeries, hospitalizations, and regular procedures (e.g., laboratory monitoring for systemic therapy) were included. We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up.The ICER at 3 years was $297,800/QALY for bilateral disease, driven by the high cost of implant therapy (difference implant - systemic [?]: $16,900; P < 0.001) and the modest gains in QALYs (? = 0.057; P = 0.22). The probability of the ICER being cost-effective at thresholds of $50,000/QALY and $100,000/QALY was 0.003 and 0.04, respectively. The ICER for unilateral disease was more favorable, namely, $41,200/QALY at 3 years, because of a smaller difference in cost between the 2 therapies (? = $5300; P = 0.44) and a larger benefit in QALYs with the implant (? = 0.130; P = 0.12). The probability of the ICER being cost-effective at thresholds of $50,000/QALY and $100,000/QALY was 0.53 and 0.74, respectively.Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate, posterior, or panuveitis but not for those with bilateral disease. These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated. Should the duration of implant effect prove to be substantially >3 years or should large changes in therapy pricing occur, the cost-effectiveness of implant versus systemic therapy would need to be reevaluated.

Dataset Information

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

Publications

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

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