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Clinical Trials/NCT06673186
NCT06673186
Completed
N/A

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

Mansoura University1 site in 1 country16 target enrollmentNovember 12, 2022
ConditionsEdentulism

Overview

Phase
N/A
Intervention
Not specified
Conditions
Edentulism
Sponsor
Mansoura University
Enrollment
16
Locations
1
Primary Endpoint
Patient Satisfaction
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 12, 2022
End Date
January 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Wageh Abozaed Elsaed Mansour

Principal Investigator

Mansoura University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Patient Satisfaction

Time Frame: 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

Time Frame: 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

Study Sites (1)

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