Effectiveness of the Single Implant-retained 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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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

This study aims to evaluate the treatment with single implant overdenture for the edentulous mandible. The investigators hypothesize that treatment with lower overdenture retained by a single implant appears to have satisfactory effectiveness as a treatment for patients with specific conditions (such as maladaptive patients), with the advantages of simplicity and greater immediate benefits when compared to the conventional full denture, improving the retention and stability of the denture and better oral-related quality of life.

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

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

NCT03691285

Edentulous Mouth

COMPLETED NA

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

NCT02710357

Mouth, Edentulous

COMPLETED NA

Mandibular Overdentures Retained by Conventional or Mini Implants

NCT01411683

Edentulous Mouth Edentulous Jaw

COMPLETED NA

Detailed Description

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

This study is a longitudinal evaluation of clinical and patient-reported outcomes related to the single-implant mandibular overdenture treatment. Sixty completely edentulous individuals will be included. First, new complete dentures will be fabricated for all of them. Panoramic radiographs and conventional tomograms of the mandibular midline region will be obtained in order to plan the implant placement surgery. After the adaptation period related to the use of the new dentures, a single implant (Titamax IT Cortical, Neodent, Curitiba, Brazil) will be installed in the mandibular midline of all participants. According to the primary stability obtained in the implant placement patients will be treated with an immediate loading protocol when achieving torque of at least 30 Ncm and implant stability quotient (ISQ) of at least 60. In cases of values below cited, conventional loading protocol will be adopted. Ball O-ring will be used as the attachment system for the mandibular overdenture. Clinical and patient-reported outcomes will be collected after 1, 3, 6 and 12 months after the installation of the overdentures.

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.

Conventional implant loading protocol

Single implant-retained mandibular overdenture

Group Type ACTIVE_COMPARATOR

Single implant-retained mandibular overdenture

Intervention Type PROCEDURE

60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment.

Immediate loading implant protocol

Single implant-retained mandibular overdenture

Group Type EXPERIMENTAL

Single implant-retained mandibular overdenture

Intervention Type PROCEDURE

60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment.

Interventions

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

Single implant-retained mandibular overdenture

60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Fully edentulous patients
* Need of replacement of the mandibular denture or patient without mandibular denture
* Patients with poor adaptation to the mandibular denture
* Patients with good general health

Exclusion Criteria

* Patients who refuse to receive a conventional dentures opposed to a mandibular overdenture retained by a single implant
* Patients with local intraoral diseases that influence denture stability, retention and adaptation of the lower denture (such as changes or anatomical deformations of the jaws, mucosal changes caused by fungi and bacteria, tumor changes and absolute xerostomia)
* Patients with systemic, psychological or neurological diseases that preclude or hinder oral movements of the patient for clinical care and/or clinical follow-up in all stages of the research
* Patients who choose other treatment modalities not covered by the study
* Patients with alcoholism or other severe behavioral disorders that compromise their participation in the study

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No