Biological Specifications for Denture Designs

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018512
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: December 2004
  Purpose

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.


Condition Intervention Phase
Tooth Loss
Procedure: Implant-supported denture
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biological Specifications for Denture Designs

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Study Start Date: October 1999
Estimated Study Completion Date: September 2004
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018512

Locations
United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00018512     History of Changes
Other Study ID Numbers: SURG-030-99S
Study First Received: July 3, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
dental implant

Additional relevant MeSH terms:
Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 23, 2014