NCT02218515

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Haner Direskeneli, Prof · Academic / Other
• Sex: All
• Age: 32 Years – 57 Years
• Healthy volunteers: Accepted

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.

Conditions

• Periodontal Bone Loss
• Chronic Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Open Flap Debridement	Open Flap Debridement (Control Group)
BIOLOGICAL	EmdogainⓇ(Enamel Matrix Derivative)	Open Flap Debridement+Enamel Matrix Derivative
BIOLOGICAL	EmdogainⓇEnamel Matrix Derivative+Autogenous Bone	Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2014-08-18
• Last updated: 2014-08-18

Locations

1 site across 1 country: Turkey (Türkiye)