Biological Specifications for Denture Designs

Tooth Loss Clinical Trial

Official title:

Biological Specifications for Denture Designs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018512
• Other study ID #: SURG-030-99S
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: October 1999
• Est. completion date: September 2004

Study information

• Verified date: December 2004
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The primary term goal of these research efforts has been to enhance the functional status, comfort and quality of life of edentulous patients by evaluating clinical procedures, denture designs and adjunctive therapies based upon a clear understanding of: (1) oral functional impairments caused by the loss of teeth and subsequent tissue changes; (2) neurophysiological mechanisms associated with oral functions; (3) metabolism of oral tissues; and (4) interactions between biological and psychological processes and denture characteristics. The primary purpose of the proposed clinical outcome study is to compare the relative efficacies of three different combinations of implant-supported maxillary and mandibular prostheses with traditional complete dentures for edentulous patients. Completion of this study will determine the relative cost-effectiveness of the implant-supported denture treatments for use in the general population of edentulous patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion criteria:

• Completely edentulous veterans with clinically acceptable conventional dentures.

• Both male and female applicants will be accepted and the prospective participants will be from 35 to 80 years of age.

• Patients who have been completely edentulous for at least two years and have clinically acceptable conventional dentures, which have been worn for at least 6 months.

Exclusion criteria:

• Verified history of medical conditions such as connective tissue disorders, blood dyscrasias, uncontrolled endocrine disorders, active tuberculosis, AIDS, leukemias, Hodgkins, liver disfunction, osteoporosis, chronic nephritis, any chronic condition with life expectancy of less than five years as well as patients on long-term steroids, anticoagulants, and radiation therapy.

• Extremely poor oral hygiene. Oral hygiene condition will be assessed from the amount of food debris, plaque and calculus in their present dentures.

• Insufficient mandibular or maxillary bone height to accommodate 10 mm long implants in potential implant sites.

• Presence of temporomandibular joint dysfunction and evidence of severe bruxism.

• Physician determines a contraindication for oral surgery.

• Candidate expresses reservations about participating for at least three years.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Procedure:
• Implant-supported denture

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,