Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration (OTBS)

August 29, 2021 updated by: tasneem gamal youssef el mashad, Cairo University

Effect of Mandibular Immediately Loaded, Screw-retained Splinted and Non-splinted OT Bridge Implant Restoration on Bone Height Changes of Completely Edentulous Patients (A Randomized Clinical Trial)

Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

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 Contact

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
  • Patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial.
  • Implant sites must allow the placement of four implants.
  • Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
  • In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.
  • Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)

Exclusion Criteria:

  • - Patients with poor oral hygiene and motivation.
  • Pregnancy or nursing.
  • Drug abusers.
  • Psychiatric problems or unrealistic expectations.
  • Patients with infection and or inflammation in the area intended for implant placement.
  • Patients participating in other studies, if the present protocol cannot be properly adhered to.
  • Patients with signs of hyperactive muscles.

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
Active Comparator: non-splinting of OT Bridge system
Leaving the dental implants abutments solitary followed by denture pick up
Procedure: Splinting of OT Bridge system
splinting of implant abutment using titanium wire followed by pick up using the patient's denture
Experimental: splinting of OT Bridge
Splinting of implants abutments using titanium wire then followed by denture pick up
Procedure: Splinting of OT Bridge system
splinting of implant abutment using titanium wire followed by pick up using the patient's denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Bone loss
Time Frame: 3 monts
Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system
3 monts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early implant failure
Time Frame: 3 months
not fulfilling one of Alberksston implant success criteria
3 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Tasneem El Mashad, Cairo 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 (Anticipated)

September 30, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 7, 2022

Study Registration Dates

First Submitted

August 29, 2021

First Submitted That Met QC Criteria

August 29, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 29, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • OTBridge

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Splinting of OT Bridge system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe