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Clinical Trials/NCT07701200
NCT07701200CompletedNot Applicable

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

Mansoura University1 site in 1 country20 target enrollmentStarted: December 13, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Patient Satisfaction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

OT- Bridge System

Experimental

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

Intervention: OT-Bridge (Device)

Multiunit Abutment Group

Active Comparator

Patients receiving multiunit abutments in mandibular All-on-4

Intervention: Multiunit (Device)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hanan Adel Ghazi

dentist

Mansoura University

Study Sites (1)

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