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

NCT06673173 | Completed DMC

• 1 other identifier: A0101024RP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulism

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

group 1 quadrilateral bar design

EXPERIMENTAL

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

group2 : Bilateral linear bar

EXPERIMENTAL

Bilateral linear Group: each participant received bar mandibular overdentures on 4 implant on bilateral configuration

Other: Implant

Interventions

Implant OTHER

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

group 1 quadrilateral bar design; group2 : Bilateral linear bar

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Heba Wageh Abozaed

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Heba Abozaed, phd

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• 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: January 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

EG (1)