Skip to main content
OpenTrials
Completed

NCT Number: NCT02218515

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

32 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Marmara University Faculty of Dentistry, Department of Periodontology

Istanbul, Şişli/Nişantaşı, 34365, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Open Flap debridement

Procedure

Open Flap Debridement (Control Group)

EmdogainⓇ(Enamel Matrix Derivative)

Biological

Open Flap Debridement+Enamel Matrix Derivative

EmdogainⓇEnamel Matrix Derivative+Autogenous Bone

Biological

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

Primary outcomes

  1. Attachment Gain

    Time frame: 6 months after surgery

Secondary outcomes

  1. Gingival crevicular fluid TGF-β1 level

    Time frame: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery

Other outcomes

  1. Plaque index

    Time frame: Baseline and 6 months post-surgery.

  2. Gingival index

    Time frame: Baseline and 6 months post-surgery

  3. Bleeding on probing

    Time frame: Baseline and 6 months post-surgery

  4. Probing depth

    Time frame: Baseline and 6 months post-surgery

  5. Relative attachment level

    Time frame: Baseline and 6 months post-surgery

  6. Recession

    Time frame: Baseline and 6 months post-surgery

  7. Intrabony defect fill percentage

    Time frame: Baseline and 6 months post-surgery

Sponsors and collaborators

Lead sponsor

Haner Direskeneli, Prof

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2014
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.