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Completed

NCT Number: NCT06673186

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

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).

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Key information

Conditions

Edentulism

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heba Wageh Abozaed

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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