Radiographic and Retention Evaluation Over Seven Years fo... | NCT07536776

Studies
Radiographic and Retention Evaluation Over Seven Years for Four Implant Retained Overdenture

NCT07536776

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Apr 17, 2026Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Marginal Bone Loss Around Implants

Interventions

implant retained overdenture

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2018Actual

Primary Completion Date

Jan 15, 2026Actual

Completion Date

Feb 20, 2026Actual

First Submitted Date

Apr 11, 2026

First Submission Date that Met QC Criteria

Apr 11, 2026

First Posted Date

Apr 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2026

Last Update Posted Date

Apr 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implant-Retained Overdenture Group	Experimental		Other: implant retained overdenture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
implant retained overdenture	Other	4 implants retained prosthesis by locators	Implant-Retained Overdenture Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Marginal Bone Loss		From the time of implant loading (Baseline) up to 7 years.

Secondary Outcomes

Measure	Description	Time Frame
Prosthetic Retention		7 years.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided