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

Phase 4

Completed

• Conditions: Periodontal Bone Loss; Chronic Periodontitis
• Interventions: Biological: EmdogainⓇ(Enamel Matrix Derivative); Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone; Procedure: Open Flap Debridement

• Registration Number: NCT02218515
• Lead Sponsor: Haner Direskeneli, Prof

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-14
• Last Update Submitted: 2014-08-14
• Study First Posted: 2014-08-18
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enamel Matrix Derivative	EmdogainⓇ(Enamel Matrix Derivative)	Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)
Enamel Matrix Derivative+Autogenous Bone	EmdogainⓇEnamel Matrix Derivative+Autogenous Bone	Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
Open Flap Debridement	Open Flap Debridement	Open Flap Debridement (Control Group)

Primary Outcome Measures

Name	Time	Method
Attachment Gain	6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Gingival crevicular fluid TGF-β1 level	1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery

Trial Locations

Locations (1)

Marmara University Faculty of Dentistry, Department of Periodontology; 🇹🇷 İstanbul, Şişli/Nişantaşı, Turkey