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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Flap Debridement | Other | Open Flap Debridement (Control Group) |
|
| Enamel Matrix Derivative | Experimental | Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative) |
|
| Enamel Matrix Derivative+Autogenous Bone | Experimental | Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Flap Debridement | Procedure | Open Flap Debridement (Control Group) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Attachment Gain | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival crevicular fluid TGF-β1 level | 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index | Baseline and 6 months post-surgery. | |
| Gingival index | Baseline and 6 months post-surgery | |
| Bleeding on probing |
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)
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| Name | Affiliation | Role |
|---|---|---|
| Ömer Birkan Ağralı, Dr. | Marmara University Faculty of Dentistry, Department of Periodontology | Principal Investigator |
| Bahar Kuru, Prof. Dr. | Marmara University, Faculty of Dentistry, Department of Periodontology | Study Chair |
| Leyla Kuru, Prof. Dr. | Marmara University, Faculty of Dentistry, Department of Periodontology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Faculty of Dentistry, Department of Periodontology | Istanbul | Şişli/Nişantaşı | 34365 | Turkey (Türkiye) |
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| EmdogainⓇ(Enamel Matrix Derivative) |
| Biological |
Open Flap Debridement+Enamel Matrix Derivative |
|
| EmdogainⓇEnamel Matrix Derivative+Autogenous Bone | Biological | Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone |
|
| Baseline and 6 months post-surgery |
| Probing depth | Baseline and 6 months post-surgery |
| Relative attachment level | Baseline and 6 months post-surgery |
| Recession | Baseline and 6 months post-surgery |
| Intrabony defect fill percentage | Baseline and 6 months post-surgery |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010518 | Periodontitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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