Back to resultsTreatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
Primary Purpose
Periodontal Bone Loss, Chronic Periodontitis
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Open Flap Debridement
EmdogainⓇ(Enamel Matrix Derivative)
EmdogainⓇEnamel Matrix Derivative+Autogenous Bone
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Bone Loss focused on measuring Autogenous bone graft, Chronic periodontitis, Enamel matrix derivatives, Gingival crevicular fluid, Periodontal flap surgery
Eligibility Criteria
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)
Sites / Locations
- Marmara University Faculty of Dentistry, Department of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Open Flap Debridement
Enamel Matrix Derivative
Enamel Matrix Derivative+Autogenous Bone
Arm Description
Open Flap Debridement (Control Group)
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
Outcomes
Primary Outcome Measures
Attachment Gain
Secondary Outcome Measures
Gingival crevicular fluid TGF-β1 level
Full Information
NCT ID
NCT02218515
First Posted
August 11, 2014
Last Updated
August 14, 2014
Sponsor
Haner Direskeneli, Prof
1. Study Identification
Unique Protocol Identification Number
NCT02218515
Brief Title
Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
Official Title
Evaluation of Gingival Crevicular Fluid Transforming Growth Factor-β1 Level After Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haner Direskeneli, Prof
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss, Chronic Periodontitis
Keywords
Autogenous bone graft, Chronic periodontitis, Enamel matrix derivatives, Gingival crevicular fluid, Periodontal flap surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Flap Debridement
Arm Type
Other
Arm Description
Open Flap Debridement (Control Group)
Arm Title
Enamel Matrix Derivative
Arm Type
Experimental
Arm Description
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)
Arm Title
Enamel Matrix Derivative+Autogenous Bone
Arm Type
Experimental
Arm Description
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
Intervention Type
Procedure
Intervention Name(s)
Open Flap Debridement
Intervention Description
Open Flap Debridement (Control Group)
Intervention Type
Biological
Intervention Name(s)
EmdogainⓇ(Enamel Matrix Derivative)
Intervention Description
Open Flap Debridement+Enamel Matrix Derivative
Intervention Type
Biological
Intervention Name(s)
EmdogainⓇEnamel Matrix Derivative+Autogenous Bone
Intervention Description
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
Primary Outcome Measure Information:
Title
Attachment Gain
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Gingival crevicular fluid TGF-β1 level
Time Frame
1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery
Other Pre-specified Outcome Measures:
Title
Plaque index
Time Frame
Baseline and 6 months post-surgery.
Title
Gingival index
Time Frame
Baseline and 6 months post-surgery
Title
Bleeding on probing
Time Frame
Baseline and 6 months post-surgery
Title
Probing depth
Time Frame
Baseline and 6 months post-surgery
Title
Relative attachment level
Time Frame
Baseline and 6 months post-surgery
Title
Recession
Time Frame
Baseline and 6 months post-surgery
Title
Intrabony defect fill percentage
Time Frame
Baseline and 6 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Birkan Ağralı, Dr.
Organizational Affiliation
Marmara University Faculty of Dentistry, Department of Periodontology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bahar Kuru, Prof. Dr.
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leyla Kuru, Prof. Dr.
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University Faculty of Dentistry, Department of Periodontology
City
İstanbul
State/Province
Şişli/Nişantaşı
ZIP/Postal Code
34365
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
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