- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536776
Radiographic and Retention Evaluation Over Seven Years for Four Implant Retained Overdenture
Marginal Bone Loss and Retention of Four-Implant Locator-Retained Mandibular Overdentures: 7 Years Follow up
ABSTRACT Statement of the problem: Insufficient long-term retrospective data is evaluating marginal bone loss and retention of four-implant Locator-retained mandibular overdentures.
Purpose: To assess marginal bone loss and retention of four-implant Locator-retained mandibular overdentures over seven years at the time of overdenture insertion (T0), 1 year (T1), and 7 years (T7) after insertion.
Material and methods: This retrospective study included 27 completely edentulous patients with maxillary single denture, and four parallel implants were placed interforaminal, and they already have a mandibular four-implant retained overdenture with LOCATOR attachments.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt
- Basma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Completely edentulous patients
- Presence of four mandibular implants supporting a Locator-retained overdenture with an opposing single maxillary denture.
- Availability of baseline and follow-up radiographs
- Minimum follow-up period of 7 years after prosthesis delivery Exclusion Criteria
1. Incomplete clinical or radiographic records 2. History of implant failure before prosthetic loading 3. Patients with peri-implantitis at baseline 4. Systemic conditions known to affect bone metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Implant-Retained Overdenture Group
|
4 implants retained prosthesis by locators
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Marginal Bone Loss
Time Frame: From the time of implant loading (Baseline) up to 7 years.
|
From the time of implant loading (Baseline) up to 7 years.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prosthetic Retention
Time Frame: 7 years.
|
7 years.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R.26.02.105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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