Cost-effectiveness of Implant Treatment for the Edentulous Mandible

NCT ID: NCT03056976

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-implant mandibular overdenture

A single midline implant and an O'ring/ball attachment to retain a mandibular overdenture

Group Type: EXPERIMENTAL

Single-implant mandibular overdenture

Intervention Type: DEVICE

Complete mandibular denture retained by a single midline implant

Two-implant mandibular overdenture

Two implants in the canine region and two O'ring/ball attachments to retain a mandibular overdenture

Group Type: EXPERIMENTAL

Two-implant mandibular overdenture

Intervention Type: DEVICE

Complete mandibular denture retained by two implants in the canine region

Fixed mandibular denture

A fixed four-implant mandibular denture

Group Type: EXPERIMENTAL

Fixed mandibular denture

Intervention Type: DEVICE

A fixed mandibular denture retained by four implants

Interventions

Single-implant mandibular overdenture

Complete mandibular denture retained by a single midline implant

Intervention Type: DEVICE

Two-implant mandibular overdenture

Complete mandibular denture retained by two implants in the canine region

Intervention Type: DEVICE

Fixed mandibular denture

A fixed mandibular denture retained by four implants

Intervention Type: DEVICE

Other Intervention Names

Single-implant overdenture; 2-implant overdenture; Full-arch mandibular prothesis

Eligibility Criteria

Inclusion Criteria

• No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
• Present enough bone volume in the mandible for implant placement without the need of bone augmentation procedures.
• Be able to understand and answer the questionnaires used in the study
• Agree to participate by providing a written informed consent.

Exclusion Criteria

• Noncompliant participants
• Individuals who do not agree to be randomly allocated to the treatment study group
• Presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Goias

OTHER

Sponsor Role: lead

Responsible Party

Cláudio Rodrigues Leles

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enilza Paiva, PhD

Role: STUDY_CHAIR

Dean of the Dental School, Federal University of Goias

References

Nogueira TE, Esfandiari S, Leles CR. Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial. Trials. 2016 Nov 4;17(1):533. doi: 10.1186/s13063-016-1646-0.

Reference Type: BACKGROUND

PMID: 27814749 (View on PubMed)

Other Identifiers

UFG_SAP_41429

Identifier Type: -

Identifier Source: org_study_id