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CompletedNCT00018512Updated Jan 21, 2009

Biological Specifications for Denture Designs

A Phase 2 interventional study of Implant-supported denture in Tooth Loss, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 35 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-21.

Sponsored by US Department of Veterans Affairs · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Non-randomized
Ages
35 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth Loss

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Keywords

  • dental implant
03

In context

Tooth Loss

224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.

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Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • ProcedureImplant-supported denture
06

Study locations

1 site
  • VA Greater Los Angeles Healthcare System
    Los Angeles, California 90073, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00018512
Lead sponsor
US Department of Veterans Affairs
First posted
Jul 5, 2001
Start date
Oct 1999
Completion
Sep 2004
Last update
Jan 21, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2004. You cannot join it, but the record below documents what was studied.

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