NCT03056976

Cost-effectiveness of Implant Treatment for the Edentulous Mandible

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Universidade Federal de Goias · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants and the mandibular fixed prosthesis retained by four implants, based on a randomized clinical trial.

Detailed description

This randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. Participants will receive conventional complete denture treatment and will be randomized into three groups: single-implant mandibular overdenture group, mandibular overdenture retained by two implants, and fixed mandibular prosthodontics retained by four implants. CBCT and panoramic radiographs will be obtained to assess if bone sites in three-dimensional terms have a minimum volume for receiving implants of at least 3.75 x 9 mm. All patients will receive Titamax IT Cortical implants (Neodent, Curitiba, Brasil) and correspondent prosthodontic components - O'ring/ball abutments for overdentures. Satisfaction with the dentures and oral health-related quality of life impacts will be considered the measures of effectiveness for the three interventions. Cost assessment and cost-effectiveness analysis will be performed from the healthcare provider perspective. Further analysis will be performed using the patient's perspective, in which the costs will be estimated according to the reference price of dental procedures and treatments of the Brazilian Dental Association (Hierarchical Brazilian Classification of Dental Procedures - CBHPO) and the gross costs will be obtained from a panel of experts. Quantification and costing of the resources will be carried out in three steps: identification of the relevant costs to the assessment; measurement of the resources used; and valuation of the resources. The costs will be calculated in Brazilian currency for each patient until one year after treatment. Incremental cost-effectiveness ratios will be calculated to assess the incremental cost for each unit of effectiveness.

Conditions

• Edentulous Mouth

Interventions

Type	Name	Description
DEVICE	Single-implant mandibular overdenture	Complete mandibular denture retained by a single midline implant
DEVICE	Two-implant mandibular overdenture	Complete mandibular denture retained by two implants in the canine region
DEVICE	Fixed mandibular denture	A fixed mandibular denture retained by four implants

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2017-02-17
• Last updated: 2020-04-16