The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans

Not Applicable

Completed

• Conditions: Alveolar Bone Loss
• Interventions: Procedure: Decortication

• Registration Number: NCT02741752
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

The purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.

Detailed Description

Background: The purpose of the current study was to evaluate the effect of cortical bone perforation on angiogenesis and osteogenesis of augmented ridge by guided bone regeneration.

Methods: Fourteen patients (mean age: 52) who were in need of dental implants at areas with osseous defects in the mandible were selected. In the test group (n=7), alveolar cortical bone at the area of regeneration was perforated using a #2 high speed round bur. No decortication of cortical bone was performed in the control group (n=7). Subsequently, defects were augmented by guided bone regeneration using resorbable membrane and bovine bone. After a healing period of 7 months, implant sites were created and trephine cores harvested for histological and histomorphometric analysis of the grafted areas.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-15
• Last Update Submitted: 2016-04-15
• Study First Posted: 2016-04-18
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Inclusion criteria were presence of atrophic mandibular ridges with bucco-lingual width ranging between 2-5 mm, as measured on serial sections of a computerized axial tomography (CAT) scan.

Exclusion Criteria

• Exclusion criteria included patients with diabetes, osteoporosis or other metabolic disorders, smokers, pregnant patients and patients who had any systemic or local factors that would inhibit normal wound healing process.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	Decortication	decortication group

Primary Outcome Measures

Name	Time	Method
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation	7 months