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Clinical Trials/NCT03628157
NCT03628157
Unknown
Phase 2

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

Cairo University1 site in 1 country10 target enrollmentSeptember 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Atrophied Anterior Maxillary Ridges
Sponsor
Cairo University
Enrollment
10
Locations
1
Primary Endpoint
Amount of bone gain (height and width in mm)
Last Updated
7 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
September 2018
End Date
August 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherif osama hegazy

principal investigator

Cairo University

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.

Outcomes

Primary Outcomes

Amount of bone gain (height and width in mm)

Time Frame: 6 months

will be measured using linear measurements from CBCT

Secondary Outcomes

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

Study Sites (1)

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