Mandibular Overdentures Retained by Conventional or Mini Implants

April 13, 2017 updated by: Raphael Freitas de Souza, University of Sao Paulo

Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial

This study aims to compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. We will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14040-904
        • Ribeirão Preto Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete edentulism;
  • Request of implant stabilization of the existing lower conventional denture;
  • Clinically acceptable maxillary and mandibular complete dentures;
  • Adequate space in the anterior mandible for the placement of four mini implants and two conventional implants (regular diameter);
  • Ability to maintain adequate oral hygiene and clean dentures;
  • Systemic health status that permits minor surgical procedures;
  • Adequate understanding of written and spoken Portuguese;
  • Capacity of giving written informed consent.

Exclusion Criteria:

  • Lack of minimum vertical mandibular bone height of 11mm in the interforaminal region;
  • Acute or chronic symptoms of parafunctional disorders;
  • History of radiation therapy to the orofacial region;
  • Specific conditions that may jeopardize the treatment, i.e. alcoholism and smoking;
  • Severe/serious illness that requires frequent hospitalization;
  • Impaired cognitive function;
  • Impossibility to return for evaluations/study recalls.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4 mini dental implants
Retention of an overdenture by means of 4 mini implants.
Device: Implant-retained mandibular overdenture
Insertion of implants in the lower arch in order to retain existing complete dentures. Tested implants are approved by the Brazilian National Health Surveillance Agency for clinical use.
Other Names:
  • - Mini-implant overdenture.
Experimental: 2 mini dental implants
Retention of an overdenture by means of 2 mini implants.
Device: Implant-retained mandibular overdenture
Insertion of implants in the lower arch in order to retain existing complete dentures. Tested implants are approved by the Brazilian National Health Surveillance Agency for clinical use.
Other Names:
  • - Mini-implant overdenture.
Active Comparator: 2 conventional dental implants
Retention of an overdenture by means of 2 conventional implants associated to ball attachments.
Device: Implant-retained mandibular overdenture
Insertion of implants in the lower arch in order to retain existing complete dentures. Tested implants are approved by the Brazilian National Health Surveillance Agency for clinical use.
Other Names:
  • - Mini-implant overdenture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Denture satisfaction
Time Frame: 2 years
To be assessed by specific questionnaires
2 years
Oral health-related quality of life
Time Frame: 2 years
To be assessed by means of the Brazilian version of the OHIP-EDENT.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical discomfort
Time Frame: 7 days
Pain and discomfort following the insertion of dental implants, as assessed by a specific questionnaire.
7 days
Success rate of implant-retained mandibular overdentures
Time Frame: 2 years
Survival of implant-retained overdentures.
2 years
Denture quality
Time Frame: 2 years
Functional aspects of mandibular overdentures, as assessed by a dentist.
2 years
Treatment costs
Time Frame: 2 years

This outcome will be measured by means of specific forms, according to 2 components:

  • Direct costs: cost of labor, materials, radiographs and medications;
  • Indirect costs: patient's time and transportation expenses.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORP-PT-004
  • 2011.1.197.58.3 (Other Identifier: Institutional Review Board (FORP-USP))
  • 2011/00688-7 (Other Grant/Funding Number: FAPESP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Edentulous Jaw

Clinical Trials on Implant-retained mandibular overdenture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe