Patient Satisfaction and Prosthetic Complications of Bar Locator Versus Bar Clip Attachments for Mandibular Two-Implant Overdentures

Not Applicable

Completed

• Conditions: Edentulism

• Registration Number: NCT06673186
• Lead Sponsor: Mansoura University

Brief Summary

Purpose: This study evaluated patient satisfaction and oral health-related- quality of life (OHRQoL) with implant overdentures retained with bar locator versus bar clip attachment for mandibular two-implant overdentures. Materials and methods: This study included sixteen edentulous patients. Every patient received new maxillary and mandibular dentures. Two dental implants have been embedded in the mandibular canine areas. The participants were randomly divided into two equal groups: Group I (bar locator): Patients were given overdentures with bar locator attachments, Group II (bar clip): Patients were given overdentures with bar clip attachment. Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.

The aim of this study was to document and report on the prosthetic complications associated with mandibular implant overdentures using bar locator and bar clip attachments. The study aimed to test the null hypothesis that the complications would not differ based on the type of retention (locator or clip).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-12
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Study First Submitted: 2024-10-31
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-01
• Last Update Submitted: 2024-11-01
• Study First Posted: 2024-11-04
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Each patient had sufficient remaining alveolar ridge in the upper and lower jaw to support implants in the lower jaw area
• a minimum length of 11 mm and a diameter of 3.7 mm, as confirmed by cone beam computed tomography.
• patient had a class I jaw relationship
• adequate space between the arches.
• healthy, firm gum tissue.

Exclusion Criteria

• participants with uncontrolled diabetes,
• heavy smoking
• drinking habits
• temporomandibular joint (TMJ) issues.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.	Patient Satisfaction
prosthetic complications	Mechanical complications were clinically examined and included Distortion /wear of retentive components, Bar screw loosening, Fracture of opposing prosthesis, Teeth wear, Fracture at the midline of the prosthesis and Teeth separation within 5 years

Trial Locations

Locations (1)

Heba Wageh Abozaed; 🇪🇬 Mansoura, Egypt