Marmara University Faculty of Dentistry, Department of Periodontology
Istanbul, Şişli/Nişantaşı, 34365, Turkey (Türkiye)
NCT Number: NCT02218515
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.
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Notify Me32 year–57 year
All sexes
Interventional
Phase 4
Istanbul, Şişli/Nişantaşı, 34365, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Open Flap Debridement (Control Group)
Open Flap Debridement+Enamel Matrix Derivative
Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
Time frame: 6 months after surgery
Time frame: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery
Time frame: Baseline and 6 months post-surgery.
Time frame: Baseline and 6 months post-surgery
Time frame: Baseline and 6 months post-surgery
Time frame: Baseline and 6 months post-surgery
Time frame: Baseline and 6 months post-surgery
Time frame: Baseline and 6 months post-surgery
Time frame: Baseline and 6 months post-surgery
Haner Direskeneli, Prof
Other
Evaluation of Gingival Crevicular Fluid Transforming Growth Factor-β1 Level After Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
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