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

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

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Key information

Conditions

Edentulism

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heba Wageh

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

overdentures with bar locator attachments

Other

Patients were given overdentures with bar locator attachments

overdentures with bar ball attachments

Other

Patients were given overdentures with bar ball attachments

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Acronym: M15011122

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Jan 28, 2026
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed