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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-10

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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

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Mouth, Edentulous Complete Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-implant mandibular overdenture

Participants allocated to this group will have a dental implant placed in the mandibular midline followed by the immediately insertion of a ball attachment and the incorporation of a retention matrix to the mandibular denture.

Group Type EXPERIMENTAL

Mandibular overdenture

Intervention Type PROCEDURE

Placement of an implant in the mandibular midline.

Mandibular complete denture

Participants allocated to this group will not receive any additional treatment besides the new set of conventional complete dentures. When needed, retreatment or any adjustment/repair in the dentures will be performed accordingly. Participants will receive regular maintenance for their dentures, including adjustments for the elimination of sore areas, denture relining and repair of fractures, when needed, until the end of the follow-up period.

Group Type ACTIVE_COMPARATOR

Mandibular complete denture

Intervention Type OTHER

No intervention.

Interventions

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Mandibular overdenture

Placement of an implant in the mandibular midline.

Intervention Type PROCEDURE

Mandibular complete denture

No intervention.

Intervention Type OTHER

Other Intervention Names

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Dental Implant (Straumann StandardPlus SLActive® RN implant) Complete denture

Eligibility Criteria

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Inclusion Criteria

* To present favorable general health and the need to be rehabilitated with a new set of complete dentures
* To agree to be randomly assigned to one of the two study groups
* To be able to comprehend and answer the data collection instruments.

Exclusion Criteria

* Presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type II diabetes mellitus or uncontrolled cardiovascular conditions)
* Insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm
* Presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders
* Inability to attend to the scheduled appointments and follow-up visits

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes