Patient Satisfaction and Oral Health-Related Quality of Life of Quadrilateral Versus Bilateral Linear Bar Designs for Four Implant Implant-Assisted Complete Mandibular Overdenture Regarding Peri-Implant Crestal Bone Loss

Not Applicable

Completed

• Conditions: Edentulism

• Registration Number: NCT06673173
• Lead Sponsor: Mansoura University

Brief Summary

For this study, twenty patients were selected, and participants were randomly divided into two groups using random numbers produced in an Excel spreadsheet. Each patient got four implants in the mandibular canine and first molar sites, as well as the bar attachment.

The purpose of this study was to document and report patient satisfaction with mandibular implant overdentures with quadrilateral distribution and linear distribution. The null hypothesis was that patient satisfaction would not be different depending on the distribution type (quadrilateral or linear).

According to the bar design, all patients were classified into two equal groups: quadrilateral bar design (group I) and bilateral linear bar design (group II). Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-10-01
• 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: 20

Inclusion Criteria

• have Angle's class I maxilla-mandibular relation
• sufficient inter-arch space
• a healthy, firm mucosa,
• enough residual alveolar ridges in the mandibular regions to support implants

Exclusion Criteria

• neuromuscular disorder,
• excessive smoking,
• alcoholism,
• parafunctional habits
• systemic disorders affecting the bones
• history of head and neck radiation therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
marginal bone loss	Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.
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.

Trial Locations

Locations (1)

Heba Wageh Abozaed; 🇪🇬 Mansoura, Egypt