NCT07536776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2018

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

8 years

First QC Date

April 11, 2026

Last Update Submit

April 11, 2026

Conditions

Marginal Bone Loss Around Implants

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Loss

    From the time of implant loading (Baseline) up to 7 years.

Secondary Outcomes (1)

  • Prosthetic Retention

    7 years.

Study Arms (1)

Implant-Retained Overdenture Group

EXPERIMENTAL
Other: implant retained overdenture

Interventions

implant retained overdentureOTHER

4 implants retained prosthesis by locators

Implant-Retained Overdenture Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basma

Al Mansurah, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

January 12, 2018

Primary Completion

January 15, 2026

Study Completion

February 20, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)