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Biological Specifications for Denture Designs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018512
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biological Specifications for Denture Designs

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018512


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

ClinicalTrials.gov Identifier: NCT00018512     History of Changes
Other Study ID Numbers: SURG-030-99S
First Submitted: July 3, 2001
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
Last Verified: December 2004

Keywords provided by VA Office of Research and Development:
dental implant

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