Clinical trial NCT02218515: Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Bone Loss
Chronic Periodontitis
Keywords: Autogenous bone graft
Chronic periodontitis
Enamel matrix derivatives
Gingival crevicular fluid
Periodontal flap surgery
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 32
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Attachment Gain
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Gingival crevicular fluid TGF-β1 level
timeFrame: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery
Other outcomes:
measure: Plaque index
timeFrame: Baseline and 6 months post-surgery.
measure: Gingival index
timeFrame: Baseline and 6 months post-surgery
measure: Bleeding on probing
timeFrame: Baseline and 6 months post-surgery
measure: Probing depth
timeFrame: Baseline and 6 months post-surgery
measure: Relative attachment level
timeFrame: Baseline and 6 months post-surgery
measure: Recession
timeFrame: Baseline and 6 months post-surgery
measure: Intrabony defect fill percentage
timeFrame: Baseline and 6 months post-surgery
Locations:
city: İstanbul
country: Turkey
facility: Marmara University Faculty of Dentistry, Department of Periodontology
state: Şişli/Nişantaşı
Study officials:
affiliation: Marmara University Faculty of Dentistry, Department of Periodontology
name: Ömer Birkan Ağralı, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
name: Bahar Kuru, Prof. Dr.
role: STUDY_CHAIR
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
name: Leyla Kuru, Prof. Dr.
role: STUDY_DIRECTOR
References: