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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218515
• Other study ID #: SAG-C-DRP-090909-0288
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2014
• Last updated: August 14, 2014
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: August 2014
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 32 Years to 57 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Chronic Periodontitis
• Periodontal Bone Loss
• Periodontitis

Intervention

Procedure:
• Open Flap Debridement
Open Flap Debridement (Control Group)

Biological:
• Emdogain?(Enamel Matrix Derivative)
Open Flap Debridement+Enamel Matrix Derivative
• Emdogain?Enamel Matrix Derivative+Autogenous Bone
Open Flap Debridement+Emdogain?(Enamel Matrix Derivative)+Autogenous Bone

Locations

Country	Name	City	State
Turkey	Marmara University Faculty of Dentistry, Department of Periodontology	Istanbul	Sisli/Nisantasi

Sponsors (1)

Lead Sponsor	Collaborator
Haner Direskeneli, Prof

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plaque index		Baseline and 6 months post-surgery.	Yes
Other	Gingival index		Baseline and 6 months post-surgery	Yes
Other	Bleeding on probing		Baseline and 6 months post-surgery	Yes
Other	Probing depth		Baseline and 6 months post-surgery	Yes
Other	Relative attachment level		Baseline and 6 months post-surgery	Yes
Other	Recession		Baseline and 6 months post-surgery	Yes
Other	Intrabony defect fill percentage		Baseline and 6 months post-surgery	Yes
Primary	Attachment Gain		6 months after surgery	Yes
Secondary	Gingival crevicular fluid TGF-ß1 level		1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery	Yes