GBR With Ptfe With Bovine Bone With and Without Autogenous
NCT ID: NCT03628157
Last Updated: 2018-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2018-09-30
2019-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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intervention
using a bio-oss bovine bone alone
Geistlich Bio-Oss® bovine bone alone
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone
control
using a bio-oss bovine bone with autogenous bone ratio 1:1
Geistlich Bio-Oss® bovine bone alone
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone
Interventions
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Geistlich Bio-Oss® bovine bone alone
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone
Eligibility Criteria
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Inclusion Criteria
* Age: 18 years and older.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate bone augmentation
Exclusion Criteria
* 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.
16 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Sherif osama hegazy
principal investigator
Locations
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Faculty of Oral and Dental Medicine
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Bone augmentation
Identifier Type: -
Identifier Source: org_study_id
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