Back to resultsGBR With Ptfe With Bovine Bone With and Without Autogenous
Primary Purpose
Atrophied Anterior Maxillary Ridges
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Geistlich Bio-Oss® bovine bone alone
Sponsored by
About this trial
This is an interventional other trial for Atrophied Anterior Maxillary Ridges
Eligibility 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.
Sites / Locations
- Faculty of Oral and Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention
control
Arm Description
using a bio-oss bovine bone alone
using a bio-oss bovine bone with autogenous bone ratio 1:1
Outcomes
Primary Outcome Measures
Amount of bone gain (height and width in mm)
will be measured using linear measurements from CBCT
Secondary Outcome Measures
a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)
a bone sample will be collected and analyzed under histo-morphometric analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03628157
Brief Title
GBR With Ptfe With Bovine Bone With and Without Autogenous
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophied Anterior Maxillary Ridges
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
using a bio-oss bovine bone alone
Arm Title
control
Arm Type
Active Comparator
Arm Description
using a bio-oss bovine bone with autogenous bone ratio 1:1
Intervention Type
Other
Intervention Name(s)
Geistlich Bio-Oss® bovine bone alone
Intervention Description
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone
Primary Outcome Measure Information:
Title
Amount of bone gain (height and width in mm)
Description
will be measured using linear measurements from CBCT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)
Description
a bone sample will be collected and analyzed under histo-morphometric analysis.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sherif hegazy, bachelor
Phone
00201008183867
Email
shekosoa@gmail.com
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hassan A ahmed, bachelor
Phone
(+202) 23642938
Email
hassan.ahmed@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GBR With Ptfe With Bovine Bone With and Without Autogenous
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