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

NCT06673186 | Completed DMC

• 1 other identifier: M21011122
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Edentulism

Outcome Measures

Primary Outcomes (2)

• Patient Satisfaction

  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.

• 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

Study Arms (2)

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

EXPERIMENTAL

Group I received mandibular overdentures with a bar locator attachment , specially designed milled bar with parallel walls was built for this group, and two holes were drilled in the top surface of the bar using a 1.7 mm bar drill to create the threaded site in the waxed bar, followed by a 2.0 mm bar tap. The locator female component was then connected to the corresponding site using a customised rider.

Other: overdenture

group2, Patients were given overdentures with bar clip attachment.

EXPERIMENTAL

bar clip attachment. Patients received mandibular overdentures with bar clip attachments. A plastic prefabricated bar was cast in cobalt-chrome alloy. Group II patients received mandibular overdentures with bar clip attachments. A plastic prefabricated bar was cast in cobalt-chrome alloy.

Other: overdenture

Interventions

overdenture OTHER

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 patients were divided into two equal groups.

Group I (bar locator): Patients were given overdentures with bar locator attachments; group2, Patients were given overdentures with bar clip attachment.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Heba Wageh Abozaed

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Denture, Overlay

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: November 12, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

EG (1)