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

NCT ID: NCT02741752

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Alveolar Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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test group

decortication group

Group Type EXPERIMENTAL

Decortication

Intervention Type PROCEDURE

cortical bone perforation

control

without decortication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decortication

cortical bone perforation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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seyedamir Danesh Sani

Principal Investigator, postgraduate resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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97345

Identifier Type: -

Identifier Source: org_study_id

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