Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft

August 14, 2014 updated by: Haner Direskeneli, Prof

Evaluation of Gingival Crevicular Fluid Transforming Growth Factor-β1 Level After Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft

The present study aimed to evaluate the effects of enamel matrix derivatives either alone or combined with autogenous bone graft applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid transforming growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test whether the use of autogenous bone graft and enamel matrix derivative combination in the treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical parameters in comparison to the use of open flap debridement alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study aimed to evaluate the effects of enamel matrix derivatives (EMD) either alone or combined with autogenous bone graft (ABG) applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid (GCF) transforming growth factor-β1 (TGF-β1) level and, to compare with open flap debridement (OFD). A total of 30 deep intrabony defects in 12 patients were randomly treated with EMD+ABG (Combination group), EMD alone (EMD group) or OFD (Control group). Clinical parameters including plaque index, gingival index, bleeding on probing, probing depth, relative attachment level and recession were recorded at baseline and 6 months post-surgery. Intrabony defect fill percentage was calculated on the standardized radiographs. TGF-β1 level was evaluated in GCF just before surgery and 7, 14, 30, 90, 180 days after surgery using ELISA.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Şişli/Nişantaşı
      • İstanbul, Şişli/Nişantaşı, Turkey, 34365
        • Marmara University Faculty of Dentistry, Department of Periodontology

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

32 years to 57 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

(a) no systemic diseases as diabetes mellitus or cardiovascular diseases that contraindicated periodontal surgery and could influence the outcome of the therapy; (b) no smoking (c) no medications affecting periodontal tissues; (d) no pregnancy or lactation; (e) a good level of oral hygiene (plaque index < 1, and full mouth bleeding on probing score <20% after initial periodontal treatment), (f) compliance with the maintenance programme and (g) presence of at least one intra-bony defect with a probing depth ≥6 mm, radiographic depth of the defect ≥3 mm as detected on the radiographs.

Exclusion Criteria:

(a) pregnancy or lactating, (b) required an antibiotic premedication, (c) received antibiotic treatment in the previous 6 months, (d) smokers, (e) whose tooth had inadequate amount of attached keratinized gingiva (<1mm)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open Flap Debridement
Open Flap Debridement (Control Group)
Procedure: Open Flap Debridement
Open Flap Debridement (Control Group)
Experimental: Enamel Matrix Derivative
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)
Biological: EmdogainⓇ(Enamel Matrix Derivative)
Open Flap Debridement+Enamel Matrix Derivative
Experimental: Enamel Matrix Derivative+Autogenous Bone
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Attachment Gain
Time Frame: 6 months after surgery
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Gingival crevicular fluid TGF-β1 level
Time Frame: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery
1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Plaque index
Time Frame: Baseline and 6 months post-surgery.
Baseline and 6 months post-surgery.
Gingival index
Time Frame: Baseline and 6 months post-surgery
Baseline and 6 months post-surgery
Bleeding on probing
Time Frame: Baseline and 6 months post-surgery
Baseline and 6 months post-surgery
Probing depth
Time Frame: Baseline and 6 months post-surgery
Baseline and 6 months post-surgery
Relative attachment level
Time Frame: Baseline and 6 months post-surgery
Baseline and 6 months post-surgery
Recession
Time Frame: Baseline and 6 months post-surgery
Baseline and 6 months post-surgery
Intrabony defect fill percentage
Time Frame: Baseline and 6 months post-surgery
Baseline and 6 months post-surgery

Collaborators and Investigators

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

Sponsor

Haner Direskeneli, Prof

Investigators

  • Principal Investigator: Ömer Birkan Ağralı, Dr., Marmara University Faculty of Dentistry, Department of Periodontology
  • Study Chair: Bahar Kuru, Prof. Dr., Marmara University, Faculty of Dentistry, Department of Periodontology
  • Study Director: Leyla KURU, Prof. Dr., Marmara University, Faculty of Dentistry, Department of Periodontology

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

September 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAG-C-DRP-090909-0288

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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