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

Mansoura University

Status: Completed

Conditions: Edentulism

Treatments: Other: overdentures with bar ball attachments; Other: overdentures with bar locator attachments

Study type: Interventional

Funder types: Other

Identifiers

NCT07373340

M15011122 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Group I (bar locator): Patients were given overdentures with bar locator attachments,

Other group

Treatment:

Other: overdentures with bar locator attachments

Group2: Patients were given overdentures with bar ball attachments

Other group

Treatment:

Other: overdentures with bar ball attachments