Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Oral health-related quality of life
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
4 mini dental implants
Retention of an overdenture by means of 4 mini implants.
Intervention: Implant-retained mandibular overdenture (Device)
2 mini dental implants
Retention of an overdenture by means of 2 mini implants.
Intervention: Implant-retained mandibular overdenture (Device)
2 conventional dental implants
Retention of an overdenture by means of 2 conventional implants associated to ball attachments.
Intervention: Implant-retained mandibular overdenture (Device)
Outcomes
Primary Outcomes
Oral health-related quality of life
Time Frame: 2 years
To be assessed by means of the Brazilian version of the OHIP-EDENT.
Denture satisfaction
Time Frame: 2 years
To be assessed by specific questionnaires
Secondary Outcomes
- Post-surgical discomfort(7 days)
- Success rate of implant-retained mandibular overdentures(2 years)
- Denture quality(2 years)
- Treatment costs(2 years)
Investigators
Raphael Freitas de Souza
Associate Professor
University of Sao Paulo