Completed

SIOverEffectiveness of the Single Implant-retained Mandibular Overdenture Treatment: Radiographic Evaluations, Patient's Satisfaction, and Oral-health-related Quality of Life

What is being tested

Single implant-retained mandibular overdenture

+ Single implant-retained mandibular overdenture

Procedure

Who is being recruted

Stomatognathic Diseases+1

+ Mouth Diseases

+ Tooth Diseases

Over 45 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: April 2013

See protocol details

Summary

Principal SponsorUniversidade Federal de Goias

Last updated: March 16, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01801566

Principal SponsorUniversidade Federal de Goias

Last updated: March 16, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesTooth DiseasesMouth, Edentulous

Criteria

4 inclusion criteria required to participate

Fully edentulous patients

Need of replacement of the mandibular denture or patient without mandibular denture

Patients with good general health

Patients with poor adaptation to the mandibular denture

5 exclusion criteria prevent from participating

Patients who choose other treatment modalities not covered by the study

Patients who refuse to receive a conventional dentures opposed to a mandibular overdenture retained by a single implant

Patients with alcoholism or other severe behavioral disorders that compromise their participation in the study

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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Single implant-retained mandibular overdenture

Group II

Experimental

Single implant-retained mandibular overdenture

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

School of Dentistry, Federal University of Goias

Goiânia, BrazilOpen School of Dentistry, Federal University of Goias in Google Maps

CompletedOne Study Center