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NCT02741752 Clinical Trial

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

Alveolar Bone Loss Clinical Trial

Official title:
The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02741752
Other study ID # 97345
Secondary ID
Status Completed
Phase N/A
First received April 11, 2016
Last updated April 15, 2016
Start date January 2015
Est. completion date January 2016

Study information
Verified date April 2016
Source Mashhad University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 72 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Decortication
cortical bone perforation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mashhad University of Medical Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary The amount of vital bone formation by histomorphometric analysis after cortical bone perforation 7 months No
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