GBR With Ptfe With Bovine Bone With and Without Autogenous

August 13, 2018 updated by: Sherif osama hegazy, Cairo University

Ridge Augmentation in Atrophic Anterior Maxillary Ridges With a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral With and Without Particulated Autogenous Bone Chips

Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.

CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.

Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio

  • 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
  • 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

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
      • Giza, Egypt, 12613
        • Faculty of Oral and Dental Medicine

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Patients with atrophied anterior maxillary ridge area.

    • Age: 18 years and older.
    • Both sexes.
    • No intraoral soft and hard tissue pathology.
    • No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

  • • Heavy smokers more than 20 cigarettes per day.(32)

    • Patients with systemic disease that may affect normal healing.
    • Psychiatric problems.
    • Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
    • Pregnant or nursing women.
    • Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
    • Patient with previous history of radiotherapy.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
using a bio-oss bovine bone alone
Other: Geistlich Bio-Oss® bovine bone alone
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone
Active Comparator: control
using a bio-oss bovine bone with autogenous bone ratio 1:1
Other: Geistlich Bio-Oss® bovine bone alone
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of bone gain (height and width in mm)
Time Frame: 6 months
will be measured using linear measurements from CBCT
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)
Time Frame: 6 months
a bone sample will be collected and analyzed under histo-morphometric analysis.
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 (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bone augmentation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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