Custom-made Ceramic Barrier vs Titanium Mesh

December 19, 2018 updated by: Mohamed El Saharty, Cairo University

Comparative Study Between Custom-made Ceramic Barrier and Titanium Mesh for Augmentation of Atrophic Posterior Mandible

It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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
      • Cairo, Egypt, 12611
        • Cairo university

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with atrophic posterior mandible
  • Both sexes
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

Exclusion Criteria:

  • Untreated gingivitis
  • Periodontitis
  • Insufficient oral hygiene
  • Previous radiation therapy
  • Head and neck neoplasia
  • Systemic disorders
  • Heavy smokers
  • Bone pathology
  • Psychiatric problems
  • Emotional instability
  • Unrealistic aesthetic demands

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: Ceramic Barrier
The use of a ceramic barrier to induce bone formation during GBR
Device: Titanium Mesh
The use of a titanium mesh to induce bone formation during GBR
Active Comparator: Titanium mesh
The use of a titanium mesh to induce bone formation during GBR
Device: Ceramic barrier
The use of a ceramic barrier to induce bone formation during GBR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone height
Time Frame: 6 months
CBCT & Three dimensional planning software to measure the height of bone gained in millimeters.
6 months
Bone width
Time Frame: 6 months
CBCT & Three dimensional planning software to measure the width of bone gained in millimeters.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometric - bone area percent
Time Frame: 6 months
Histomorphometric analysis of bone area percent
6 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 (Actual)

July 1, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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