OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.

July 13, 2026 updated by: Hanan Adel Ghazi, Mansoura University

Patient Satisfaction and Prosthetic Complication of OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.

This study aims to compare two different prosthetic systems used in mandibular full-arch implant-supported fixed prostheses (All-on-4). The study evaluates patient satisfaction and prosthetic complications associated with the OT-Bridge system versus multiunit abutments.

A total of 20 patients will be included and divided into two equal groups. All patients will receive implant-supported screw-retained fixed prostheses.

Clinical and prosthetic outcomes will be assessed at baseline (T0), 6 months (T6), and 12 months (T12), including evaluation of patient satisfaction and any prosthetic complications.

The findings of this study may help improve the selection of prosthetic systems to enhance clinical outcomes and patient quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt, 00000
        • Ministry of Health and Population, Egypt - Kafr Demira Health Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients (≥18 years) with edentulous mandible.
  • Patients receiving or having received All-on-4 dental implants in the mandible.
  • Adequate implant stability to support prosthetic loading.
  • Patients indicated for screw-retained full-arch fixed prostheses using either OT-Bridge system or multiunit abutments.
  • Patients willing to participate and attend follow-up visits at T0, T6, and T12 months.

Exclusion Criteria:

  • Patients with uncontrolled systemic conditions affecting healing (e.g., uncontrolled diabetes).
  • Patients with failed or mobile implants.
  • Severe parafunctional habits (e.g., uncontrolled bruxism).
  • Poor oral hygiene compliance.
  • Patients unable to attend follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OT- Bridge System
Patients receiving OT-Bridge prosthetic system in mandibular All-on-4
Device: OT-Bridge
OT-Bridge system is a prosthetic attachment system used for implant-supported fixed full-arch prostheses. It is designed to connect implants and provide a screw-retained restoration for mandibular All-on-4 cases, allowing improved prosthetic stability and passive fit.
Active Comparator: Multiunit Abutment Group
Patients receiving multiunit abutments in mandibular All-on-4
Device: Multiunit
Multiunit abutments are prosthetic components used in implant-supported full-arch fixed prostheses. They are placed on dental implants to correct angulation and provide a stable platform for screw-retained mandibular All-on-4 restorations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Baseline, 6 months, 12 months
Patient satisfaction will be assessed using a structured questionnaire for patients receiving mandibular All-on-4 implant-supported fixed prostheses. Satisfaction will be evaluated at baseline (T0), 6 months (T6), and 12 months (T12) after prosthesis delivery, comparing OT-Bridge system and multiunit abutments.
Baseline, 6 months, 12 months
Prosthetic Complications
Time Frame: Baseline, 6 months, 12 months
Prosthetic complications will be recorded for both groups, including screw loosening, prosthesis fracture, loss of retention, and need for maintenance or adjustment. Evaluations will be performed at T0, T6, and T12 months in mandibular All-on-4 implant-supported prostheses.
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Actual)

July 10, 2025

Study Completion (Actual)

July 10, 2025

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • A06012023RP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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