Cost-effectiveness of Implant Treatment for the Edentulous Mandible

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cost-effectiveness of Implant Treatment for the Edentulous Mandible

Conditions
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Edentulous Mouth

Intervention / Treatment
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* Device: Single-implant mandibular overdenture
* Device: Two-implant mandibular overdenture
* Device: Fixed mandibular denture


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative effectiveness of thre competing strategies for the edentulous mandible using implants
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-implant mandibular overdenture<br>A single midline implant and an O'ring/ball attachment to retain a mandibular overdenture | Device: Single-implant mandibular overdenture<br>* Complete mandibular denture retained by a single midline implant<br>* Other names: Single-implant overdenture;|
| Experimental: Two-implant mandibular overdenture<br>Two implants in the canine region and two O'ring/ball attachments to retain a mandibular overdenture | Device: Two-implant mandibular overdenture<br>* Complete mandibular denture retained by two implants in the canine region<br>* Other names: 2-implant overdenture;|
| Experimental: Fixed mandibular denture<br>A fixed four-implant mandibular denture | Device: Fixed mandibular denture<br>* A fixed mandibular denture retained by four implants<br>* Other names: Full-arch mandibular prothesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the dentures | A 10 cm uninterrupted visual analogue scale will be used in order to assess the participants' ratings of their satisfaction with the upper and lower dentures in relation to the parameters general satisfaction, comfort, stability, aesthetics, ability to speak and ability to chew. | 1-year | 
| Oral health-related quality of life impacts | Oral Health Impact Profile Instrument for edentulous subjects (OHIP-EDENT) in order to assess the impact of oral health conditions on quality of life of participants. | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Masticatory efficiency | Masticatory efficiency will be assessed as a secondary outcome using a two-colored chewing gum test and a qualitative and quantitative colourimetric method to measure the color-mixing ability. | 1-year | 
| Cost | Direct and indirect treatment costs | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overdenture, Dental implant, Complete denture, Cost analysis