Dental Implantation Clinical Trial
Official title:
Clinical Investigation of Mandibular Implant Overdenture
Verified date | January 2010 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond, | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | National Institute of Dental and Craniofacial Research (NIDCR), Nobel Biocare |
United States,
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 |
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