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

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.

Study Overview

• Status: Completed
• Conditions: Edentulism
• Intervention / Treatment: Other: Implant

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Heba Wageh Abozaed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1 quadrilateral bar design; Quadrilateral Group: each participant received bar mandibular overdentures on 4 implants with quadrilateral distribution. A plastic ready-made bar was cast in cobalt chrome alloy.	Other: Implant; A long cone paralleling approach with a specially made film holder will be used to assess each patient's vertical marginal bone loss to ensure standardized radiography analysis and avoid any magnification errors. The linear distance between the proximal crestal bone level and the implant shoulder will be measured at the mesial and distal aspects of the implant measured in millimeters (mm). Measurements will performed using image measurement software patient satisfaction comparison between 2 groups
Experimental: group2 : Bilateral linear bar; Bilateral linear Group: each participant received bar mandibular overdentures on 4 implant on bilateral configuration	Other: Implant; A long cone paralleling approach with a specially made film holder will be used to assess each patient's vertical marginal bone loss to ensure standardized radiography analysis and avoid any magnification errors. The linear distance between the proximal crestal bone level and the implant shoulder will be measured at the mesial and distal aspects of the implant measured in millimeters (mm). Measurements will performed using image measurement software patient satisfaction comparison between 2 groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Heba Abozaed, phd, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A0101024RP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No