A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture Treatment

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by a single implant. The study hypothesis is that SIMO is more effective but more costly than the conventional denture, though this incremental cost is relatively low for the offered effectiveness in terms of clinical and patient-reported outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cost-effectiveness of Implant Treatment for the Edentulous Mandible

NCT03056976

Edentulous Mouth

COMPLETED NA

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

NCT03463174

Mouth, Edentulous Complete Edentulism

COMPLETED NA

Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment

NCT01801566

Mouth, Edentulous

COMPLETED NA

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

NCT03691285

Edentulous Mouth

COMPLETED NA

3D Printing for the Fabrication of Mandibular Implant Overdentures

NCT06155630

Edentulous Mouth Edentulous Jaw

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This randomized clinical trial alongside a cost-effectiveness analysis will include twenty-eight 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 a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline. 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. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Mouth, Edentulous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mandibular complete denture

Participants allocated to this group will not receive any additional treatment. 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 PROCEDURE

No intervention. Maintenance of the dentures will be done when needed.

Single-implant mandibular overdenture

Participants allocated to this group will have an implant placed in the mandibular midline and after 4 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 an implant in the mandibular midline.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mandibular Overdenture

Placement of an implant in the mandibular midline.

Intervention Type PROCEDURE

Mandibular complete denture

No intervention. Maintenance of the dentures will be done when needed.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dental Implant (Straumann Standard Plus SLActive® RN implant

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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