The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decortication
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss focused on measuring histomorphometry
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
test group
control
Arm Description
decortication group
without decortication
Outcomes
Primary Outcome Measures
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
Secondary Outcome Measures
Full Information
NCT ID
NCT02741752
First Posted
April 11, 2016
Last Updated
April 15, 2016
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02741752
Brief Title
The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans
Official Title
The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
histomorphometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm Description
decortication group
Arm Title
control
Arm Type
No Intervention
Arm Description
without decortication
Intervention Type
Procedure
Intervention Name(s)
Decortication
Intervention Description
cortical bone perforation
Primary Outcome Measure Information:
Title
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
AA
Learn more about this trial
The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans
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