Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-09

Study Completion Date

2019-07-30

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, based on a randomized clinical trial.

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Detailed Description

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This randomized clinical trial alongside a cost-effectiveness analysis will include 48 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: mandibular overdenture retained by two implants group or single-implant mandibular overdenture group. Each participant allocated to the single-implant mandibular overdenture group will then receive a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline, and the mandibular overdenture retained by two implants group will receive two implants of the same specification, in the interphoramen region. A healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. Then, a 3.4mm retentive titanium anchor abutment (Straumann 048.439, Institute Straumann AG, Basel, Switzerland) will be connected and tightened to 35 N.cm with a torque wrench. The matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. Outcomes (satisfaction with the dentures and oral health-related quality of life) will be measured at baseline and at the 6- and 12-month follow-up. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Conditions

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Edentulous Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparative effectiveness of two competing strategies for the edentulous mandible using implants

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

To avoid selection bias and ensure adequate allocation concealment, their treatment group will only be revealed for each participant after the assessment of the baseline outcomes, which will occur after the delivery and regular use of the new set of conventional dentures. Since full blinding for the two interventions is not possible for those involved with treatment management and collection of data, only those collecting and analyzing clinical data from masticatory performance tests will be unaware of the assigned treatment.

Study Groups

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Single-implant mandibular overdenture

Participants allocated to this group will have an implant placed in the mandibular midline and after 3 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture.

Group Type EXPERIMENTAL

Mandibular Overdenture

Intervention Type PROCEDURE

Placement of 1 or 2 implants in the anterior region of the edentulous mandible.

Two-implant mandibular overdenture

Participants allocated to this group will have two implants placed in the inter-foraminal region after 3 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture.

Group Type ACTIVE_COMPARATOR

Mandibular Overdenture

Intervention Type PROCEDURE

Placement of 1 or 2 implants in the anterior region of the edentulous mandible.

Interventions

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Mandibular Overdenture

Placement of 1 or 2 implants in the anterior region of the edentulous mandible.

Intervention Type PROCEDURE

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 mandibular midline area 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

Yes