Clinical Investigation of Mandibular Implant Overdenture

Dental Implantation Clinical Trial

Official title:

Clinical Investigation of Mandibular Implant Overdenture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066014
• Other study ID #: NIDCR-12204
• Secondary ID: R01DE012204
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2003
• Last updated: February 21, 2012
• Start date: November 1998
• Est. completion date: January 2007

Study information

• Verified date: January 2010
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00000366

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Implantation

Intervention

Procedure:
• Implant Overdenture Treatment
All overdenture treatment modalities were provided to each subject using a crossover design.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond,	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Dental and Craniofacial Research (NIDCR), Nobel Biocare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes		6 month and 12 month	No