NCT03463174

Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture

A Randomized Controlled Clinical Trial Alongside a Cost-effectiveness Analysis of the Mandibular Conventional Complete Denture Versus Single-implant Mandibular Overdenture

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Universidade Federal de Goias · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture.

Detailed description

This randomized clinical trial alongside a cost-effectiveness analysis will include edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. Each participant allocated to the overdenture group will then receive an implant (Titamax TI cortical - Neodent, Brazil) in the mandibular midline followed by the immediate connection of an O-Ring/ball attachment with intra-oral incorporation of the retention system in the mandibular denture. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. 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.

Conditions

• Mouth, Edentulous
• Complete Edentulism

Interventions

Type	Name	Description
PROCEDURE	Mandibular overdenture	Placement of an implant in the mandibular midline.
OTHER	Mandibular complete denture	No intervention.

Timeline

• Start date: 2015-03-10
• Primary completion: 2017-09-20
• Completion: 2017-10-31
• First posted: 2018-03-13
• Last updated: 2018-03-13

Locations

1 site across 1 country: Brazil