GBR With Ptfe With Bovine Bone With and Without Autogenous

Phase 2

• Conditions: Atrophied Anterior Maxillary Ridges

• 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

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14
• Study Start: 2018-09
• Primary Completion: 2018-12
• Study Completion: 2019-08

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of bone gain (height and width in mm)	6 months	will be measured using linear measurements from CBCT

Secondary Outcome Measures

Name	Time	Method
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