MedPath

GBR With Ptfe With Bovine Bone With and Without Autogenous

Phase 2
Conditions
Atrophied Anterior Maxillary Ridges
Interventions
Other: Geistlich Bio-Oss® bovine bone alone
Registration Number
NCT03628157
Lead Sponsor
Cairo University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
10
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
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
interventionGeistlich Bio-Oss® bovine bone aloneusing a bio-oss bovine bone alone
controlGeistlich Bio-Oss® bovine bone aloneusing a bio-oss bovine bone with autogenous bone ratio 1:1
Primary Outcome Measures
NameTimeMethod
Amount of bone gain (height and width in mm)6 months

will be measured using linear measurements from CBCT

Secondary Outcome Measures
NameTimeMethod
a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)6 months

a bone sample will be collected and analyzed under histo-morphometric analysis.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine

🇪🇬

Giza, Egypt

© Copyright 2025. All Rights Reserved by MedPath