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Clinical Investigation of Mandibular Implant Overdenture

This study has been completed.
Sponsor:
Collaborators:
Nobel Biocare
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00066014
First received: August 1, 2003
Last updated: February 21, 2012
Last verified: January 2010
  Purpose

The purpose of this study is to compare the effectiveness of three variable dental implant attachment methodologies in conjunction with lower dental-implant retained/supported complete overdenture treatment. These three methods are all presently used by dental practitioners, but vary significantly in terms of added treatment cost and complexity. The study tests the hypothesis that the least complex and costly method provides an equivalent treatment outcome to other more complex and costly methods.


Condition Intervention Phase
Dental Implantation
Procedure: Implant Overdenture Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of Mandibular Implant Overdenture

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 1998
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment modalities changed for comparison
All subjects experienced all treatment modalities being studied.
Procedure: Implant Overdenture Treatment
All overdenture treatment modalities were provided to each subject using a crossover design.

Detailed Description:

This project utilizes 30 subjects in a prospective, randomly assigned clinical study that uses a four-period, six sequence, three treatment crossover design to test the hypothesis that defined outcomes of variable implant overdenture treatments are equivalent. The project tests three overdenture treatment modalities, (1) four-implant, bar/clip-attached treatment, (2) two-implant, bar/clip-attached treatment, and (3) two-implant independently attached (O-ring) treatment. Each subject has four dental implants placed into the anterior mandible and new dentures are fabricated. After successful implant integration, subjects are randomly assigned to one of six sequences of treatment. Each treatment is followed for data collection for at least twelve months before the mandibular denture is modified to incorporate the next treatment in the sequence. Equivalence is measured in terms of prosthesis retention, stability, supporting and peri-implant tissue response, patient satisfaction/preference and treatment complications/failures.

Information from this study will assist dental practitioners during treatment planning in selecting appropriate and cost effective treatment choices. There is an inverse relationship between edentulism in the U.S. population and socioeconomic status. If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costly/complex methods, these simplified treatments can be used to treat a larger percentage of the edentulous population.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Adult patient;
  • Male or female;
  • At least one year of previous conventional complete denture treatment history;
  • Willing to accept the conditions of the study and informed consent freely given;
  • Ability to participate for 6 years;
  • Able to understand and respond to self-reporting measurement scales used in the study;
  • Minimum 20-mm interarch distance at the estimated vertical dimension of occlusion;
  • Adequate bone quality;
  • Adequate bone quantity to accommodate minimally four 3.75-mm diameter by 7-mm long Brånemark implants.

Exclusion:

  • Administrative or physical considerations which would seriously affect the surgical procedure or construe a hindrance for a six-year involvement;
  • History of drug or alcohol abuse;
  • Excessive smoking (1+ pack/day);
  • Uncontrolled systemic disease;
  • Inability to undergo minor oral surgery because of health or personal reasons;
  • Irradiated surgical site;
  • Unrealistic expectations of the prosthodontic treatment outcome;
  • Psychological or psychiatric conditions that could influence the subject's reaction to treatment;
  • Acute or chronic TMD problems;
  • pregnancy;
  • Class II jaw relationship;
  • Conventional dental treatment the treatment of choice.
  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: NCT00066014

Locations
United States, Virginia
Virginia Commonwealth University
Richmond,, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Nobel Biocare
Investigators
Principal Investigator: David R Burns Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00066014     History of Changes
Obsolete Identifiers: NCT00000366
Other Study ID Numbers: NIDCR-12204, R01DE012204
Study First Received: August 1, 2003
Last Updated: February 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
Dental Implantation-Osseointegrated
Dentures
Dental Prostheses
Denture, Implant-Supported

ClinicalTrials.gov processed this record on November 25, 2014