Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GBR With Ptfe With Bovine Bone With and Without Autogenous

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03628157
Recruitment Status : Unknown
Verified August 2018 by Sherif osama hegazy, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sherif osama hegazy, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Atrophied Anterior Maxillary Ridges Other: Geistlich Bio-Oss® bovine bone alone Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: 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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Amount of bone gain (height and width in mm) [ Time Frame: 6 months ]
    will be measured using linear measurements from CBCT


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628157


Contacts
Layout table for location contacts
Contact: sherif hegazy, bachelor 00201008183867 shekosoa@gmail.com

Locations
Layout table for location information
Egypt
Faculty of Oral and Dental Medicine
Giza, Egypt, 12613
Contact: hassan A ahmed, bachelor    (+202) 23642938    hassan.ahmed@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sherif osama hegazy, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03628157    
Other Study ID Numbers: Bone augmentation
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrophy
Pathological Conditions, Anatomical