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

April 15, 2016 updated by: seyedamir Danesh Sani, Mashhad University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test group
decortication group
Procedure: Decortication
cortical bone perforation
No Intervention: control
without decortication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

AA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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