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Clinical Investigation of Mandibular Implant Overdenture

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ClinicalTrials.gov Identifier: NCT00066014
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : February 22, 2012
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
Nobel Biocare
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dental Implantation Procedure: Implant Overdenture Treatment Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of Mandibular Implant Overdenture
Study Start Date : November 1998
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes [ Time Frame: 6 month and 12 month ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00066014


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond,, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Dental and Craniofacial Research (NIDCR)
Nobel Biocare
Investigators
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Principal Investigator: David R Burns Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00066014    
Obsolete Identifiers: NCT00000366
Other Study ID Numbers: NIDCR-12204
R01DE012204 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: January 2010
Keywords provided by Virginia Commonwealth University:
Dental Implantation-Osseointegrated
Dentures
Dental Prostheses
Denture, Implant-Supported