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

NCT ID: NCT06673186

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-12
• Study Completion Date: 2024-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

overdenture

Intervention Type: 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.

group2, Patients were given overdentures with bar clip attachment.

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.

Group Type: EXPERIMENTAL

overdenture

Intervention Type: 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.

Interventions

overdenture

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Heba Wageh Abozaed Elsaed Mansour

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heba Wageh Abozaed

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

M21011122

Identifier Type: -

Identifier Source: org_study_id