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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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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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Detailed Description

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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

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Periodontal Bone Loss Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Flap Debridement

Open Flap Debridement (Control Group)

Group Type OTHER

Open Flap Debridement

Intervention Type PROCEDURE

Open Flap Debridement (Control Group)

Enamel Matrix Derivative

Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)

Group Type EXPERIMENTAL

EmdogainⓇ(Enamel Matrix Derivative)

Intervention Type BIOLOGICAL

Open Flap Debridement+Enamel Matrix Derivative

Enamel Matrix Derivative+Autogenous Bone

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

Group Type EXPERIMENTAL

EmdogainⓇEnamel Matrix Derivative+Autogenous Bone

Intervention Type BIOLOGICAL

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

Interventions

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Open Flap Debridement

Open Flap Debridement (Control Group)

Intervention Type PROCEDURE

EmdogainⓇ(Enamel Matrix Derivative)

Open Flap Debridement+Enamel Matrix Derivative

Intervention Type BIOLOGICAL

EmdogainⓇEnamel Matrix Derivative+Autogenous Bone

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

32 Years

Maximum Eligible Age

57 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes