Crestal Bone Level After Allogenic Bone Ring With Simultaneous Dental Implant Placement

April 4, 2019 updated by: Alaa El-Deen Ragab Mahmoud, Cairo University

Evaluation Of Crestal Bone Level After Alveolar Bone Augmentation of Atrophied Posterior Mandibular Region Using Allogenic Bone Rings Vs. Autogenous Bone Rings With Simultaneous Dental Implant Placement (A Randomized Controlled Clinical Trial)

This trial is aiming to answer a question whether in Patients with severely atrophied, distal mandibular regions, the use of allogenic bone rings with simultaneous dental implants, compared to autogenous bone rings, give successful clinical and radiographic outcomes without donor site morbidity

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

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

Study Contact Backup

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medically free form any systemic diseases that contraindicate the surgical procedures or affect predictable outcomes and non-smoker subjects.
  2. Atrophic mandibular distal region requiring vertical augmentation.
  3. Good oral hygiene and healthy keratinized mucosa.

Exclusion Criteria:

  1. Presence of acute dentoalveolar infection or any pathologic lesions.
  2. Totally edentulous patients and patients requiring massive reconstruction and augmentation procedures.
  3. Patients with history of previously failed augmentation procedures, or failed implant placement at the intended augmentation region.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: allogenic bone ring
Procedure: allogenic bone ring
allogenic bone ring with simultaneous dental implant placement
Active Comparator: autogenous bone ring
Procedure: autogenous bone ring
autogenous bone ring with simultaneous dental implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in crestal bone height
Time Frame: at 6 months
cone beam computed tomography will be used to measure bone height in millimeters
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
graft failure
Time Frame: after 1 week, 6 months and after 9 months
signs of graft failure will be evaluated by clinical examination
after 1 week, 6 months and after 9 months
implant loss
Time Frame: after 1 week, 6 months and after 9 months
signs of implant loss will be evaluated by clinical examination
after 1 week, 6 months and after 9 months

Collaborators and Investigators

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

Sponsor

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)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • allogenic bone ring

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.

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