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

Haner Direskeneli, Prof

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis; Periodontal Bone Loss

Treatments: Biological: EmdogainⓇ(Enamel Matrix Derivative); Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone; Procedure: Open Flap Debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT02218515

SAG-C-DRP-090909-0288

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 32 to 57 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Open Flap Debridement

Other group

Description:

Open Flap Debridement (Control Group)

Treatment:

Procedure: Open Flap Debridement

Enamel Matrix Derivative

Experimental group

Description:

Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)

Treatment:

Biological: EmdogainⓇ(Enamel Matrix Derivative)

Enamel Matrix Derivative+Autogenous Bone

Experimental group

Description:

Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone

Treatment:

Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone