Cost-effectiveness of Implant Treatment for the Edentulous Mandible (CEAIMPLANT)

Universidade Federal de Goias

Status: Completed

Conditions: Edentulous Mouth

Treatments: Device: Fixed mandibular denture; Device: Single-implant mandibular overdenture; Device: Two-implant mandibular overdenture

Study type: Interventional

Funder types: Other

Identifiers

NCT03056976

UFG_SAP_41429

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 3 patient groups

Single-implant mandibular overdenture

Experimental group

Description:

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

Treatment:

Device: Single-implant mandibular overdenture

Two-implant mandibular overdenture

Experimental group

Description:

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

Treatment:

Device: Two-implant mandibular overdenture

Fixed mandibular denture

Experimental group

Description:

A fixed four-implant mandibular denture

Treatment:

Device: Fixed mandibular denture