Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066014
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2003-08-01
Brief Title:
Clinical Investigation of Mandibular Implant Overdenture
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Clinical Investigation of Mandibular Implant Overdenture
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 retainedsupported 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
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 barclip-attached treatment 2 two-implant barclip-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 satisfactionpreference and treatment complicationsfailures
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 US population and socioeconomic status If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costlycomplex methods these simplified treatments can be used to treat a larger percentage of the edentulous population
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 US population and socioeconomic status If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costlycomplex methods these simplified treatments can be used to treat a larger percentage of the edentulous population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE012204 | NIH | None | httpsreporternihgovquickSearchR01DE012204 |