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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07373340
Acronym
M15011122
Enrollment
10
Registered
2026-01-28
Start date
2022-11-01
Completion date
2026-01-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulism

Keywords

implant, overdenture, bar

Brief summary

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

Interventions

OTHERoverdentures with bar locator attachments

Patients were given overdentures with bar locator attachments

OTHERoverdentures with bar ball attachments

Patients were given overdentures with bar ball attachments

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
patient-reported outcomesPatient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertionPatient satisfaction (primary outcome) between bar locator and bar ball using a McGill-based study at T0 and after 6 months of overdenture insertion
complicationsprosthetic complication was evaluated From enrollment to the end of treatment at 3 yearsprosthetic complication between bar locator and bar ball

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026