A Pilot Randomized Clinical Study Comparing Patient-Reported Outcomes and Complications for Mandibular Implant Overdentures Retained by Different Splinted Attachment Systems (M15011122)

January 20, 2026 updated by: Heba Wageh Abozaed Elsaed Mansour, Mansoura University
This exploratory pilot randomized clinical study enrolled ten completely edentulous participants who experienced retention and stability problems with conventional mandibular complete dentures. Participants were randomly allocated to receive mandibular implant-supported overdentures retained by either a bar-locator attachment system (n = 5) or a bar-ball attachment system (n = 5). Denture satisfaction was assessed using the McGill Denture Satisfaction Questionnaire

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Heba Wageh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligibility criteria incomplete mandibular edentulism for at least one year, adequate bone volume in the interforaminal region to permit implant placement, a documented history of insufficient retention and/or stability with a conventional mandibular complete denture.

Exclusion Criteria:

comprised uncontrolled systemic diseases, previous radiotherapy to the head and neck region, severe parafunctional habits, and any medical or local contraindications to implant surgery.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group I (bar locator): Patients were given overdentures with bar locator attachments,
Other: overdentures with bar locator attachments
Patients were given overdentures with bar locator attachments
Other: Group2: Patients were given overdentures with bar ball attachments
Other: overdentures with bar ball attachments
Patients were given overdentures with bar ball attachments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient-reported outcomes
Time Frame: Patient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertion
Patient satisfaction (primary outcome) between bar locator and bar ball using a McGill-based study at T0 and after 6 months of overdenture insertion
Patient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertion
complications
Time Frame: prosthetic complication was evaluated From enrollment to the end of treatment at 3 years
prosthetic complication between bar locator and bar ball
prosthetic complication was evaluated From enrollment to the end of treatment at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15011122 (Registry Identifier: Mansoyra university)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Edentulism

Clinical Trials on overdentures with bar locator attachments

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe