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

NCT07701200 | Completed

• 1 other identifier: A06012023RP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complete Edentulism; All-on-4; Implant Supported Prosthesis; Multiunnit Abutments; OT- Bridge

Outcome Measures

Primary Outcomes (2)

• Patient Satisfaction

  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

  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

Study Arms (2)

OT- Bridge System

EXPERIMENTAL

Patients receiving OT-Bridge prosthetic system in mandibular All-on-4

Device: OT-Bridge

Multiunit Abutment Group

ACTIVE COMPARATOR

Patients receiving multiunit abutments in mandibular All-on-4

Device: Multiunit

Interventions

OT-Bridge DEVICE

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.

OT- Bridge System

Multiunit DEVICE

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.

Multiunit Abutment Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ministry of Health and Population, Egypt - Kafr Demira Health Unit

Al Mansurah, 00000, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: July 14, 2026
• Study Start: December 13, 2023
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: July 14, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)