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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontal Bone Loss, Chronic Periodontitis

Intervention / Treatment
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* Procedure: Open Flap Debridement
* Biological: EmdogainⓇ(Enamel Matrix Derivative)
* Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 32 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attachment Gain |  | 6 months after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autogenous bone graft, Chronic periodontitis, Enamel matrix derivatives, Gingival crevicular fluid, Periodontal flap surgery