- 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
-
-
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Al Mansurah, Egypt
- Basma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria Patients rehabilitated with a mandibular overdenture retained by four dental implants.
Four implants positioned in the anterior and premolar regions of the mandible. Four Locator attachments used to retain the mandibular overdenture. Availability of baseline clinical and radiographic records at the time of prosthesis insertion.
Availability of clinical and radiographic records at 1-year and 7-year follow-up.
Exclusion Criteria Patients with incomplete clinical or radiographic records. Patients without the required 1-year or 7-year follow-up records. Patients with radiographs that were inadequate for reliable assessment of peri-implant marginal bone levels.
Patients whose records did not allow assessment of prosthetic retention at the specified follow-up periods.
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
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4 implants retained prosthesis by locators
A mandibular overdenture retained by four dental implants using Locator attachments.
The implants are positioned in the anterior and premolar regions of the mandible, and the prosthesis is retained by four Locator attachments.
Patients are followed clinically and radiographically over the follow-up period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal Bone Loss by periapical radiography
Time Frame: From the time of implant loading (Baseline), 1year and 7 years.
|
Marginal bone loss will be assessed using standardized intraoral periapical radiographs.
The vertical distance from the implant reference point to the alveolar bone crest will be measured on the mesial and distal surfaces of each implant.
Measurements will be recorded at implant insertion (baseline), 1 year, and 7 years, and the mean value of the four implants will be calculated for each patient.
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From the time of implant loading (Baseline), 1year and 7 years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prosthetic Retention by a digital force gauge
Time Frame: baseline, 1year and 7 years.
|
Prosthetic retention will be assessed by measuring the dislodging force required to remove the mandibular overdenture using a digital force gauge.
The retention force will be recorded in Newtons (N) at baseline and at 7 years after insertion.
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baseline, 1year and 7 years.
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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
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