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

University of Sao Paulo1 site in 1 country120 target enrollmentSeptember 2011

ConditionsEdentulous Mouth Edentulous Jaw

Overview

Phase: N/A
Intervention: Not specified
Conditions: Edentulous Mouth
Sponsor: University of Sao Paulo
Enrollment: 120
Locations: 1
Primary Endpoint: Oral health-related quality of life
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

April 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Sao Paulo

Responsible Party

Principal Investigator

Raphael Freitas de Souza

Associate Professor

University of Sao Paulo

Eligibility Criteria

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.