Clinical Investigation of Mandibular Implant Overdenture

NCT00066014 | Completed Phase 2 DMC

• 2 other identifiers: NIDCR-12204R01DE012204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implantation

Keywords

Dental Implantation-Osseointegrated; Dentures; Dental Prostheses; Denture, Implant-Supported

Outcome Measures

Primary Outcomes (1)

• Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes

  6 month and 12 month

Study Arms (1)

treatment modalities changed for comparison

ACTIVE COMPARATOR

All subjects experienced all treatment modalities being studied.

Procedure: Implant Overdenture Treatment

Interventions

Implant Overdenture Treatment PROCEDURE

All overdenture treatment modalities were provided to each subject using a crossover design.

treatment modalities changed for comparison

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• Nobel Biocare: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• David R Burns

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2003
• First Posted: August 5, 2003
• Study Start: November 1, 1998
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: February 22, 2012

Record last verified: 2010-01

Locations

US (1)