Biological Specifications for Denture Designs - Tabular View

Tracking Information
First Received Date ^ICMJE	July 3, 2001
Last Updated Date	January 20, 2009
Start Date ^ICMJE	October 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00018512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Biological Specifications for Denture Designs
Official Title ^ICMJE	Biological Specifications for Denture Designs
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Tooth Loss
Intervention ^ICMJE	Procedure: Implant-supported denture
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	September 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	35 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00018512
Responsible Party
Study ID Numbers ^ICMJE	SURG-030-99S
Study Sponsor ^ICMJE	Department of Veterans Affairs
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Department of Veterans Affairs
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP