Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02218515
Enrollment
30
Registered
2014-08-18
Start date
2010-09-30
Completion date
2012-09-30
Last updated
2014-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis, Periodontal Bone Loss

Keywords

Autogenous bone graft, Chronic periodontitis, Enamel matrix derivatives, Gingival crevicular fluid, Periodontal flap surgery

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.

Interventions

PROCEDUREOpen Flap Debridement

Open Flap Debridement (Control Group)

BIOLOGICALEmdogainⓇ(Enamel Matrix Derivative)

Open Flap Debridement+Enamel Matrix Derivative

BIOLOGICALEmdogainⓇEnamel Matrix Derivative+Autogenous Bone

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

Sponsors

Haner Direskeneli, Prof
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
32 Years to 57 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Attachment Gain6 months after surgery

Secondary

MeasureTime frame
Gingival crevicular fluid TGF-β1 level1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery

Other

MeasureTime frame
Gingival indexBaseline and 6 months post-surgery
Bleeding on probingBaseline and 6 months post-surgery
Probing depthBaseline and 6 months post-surgery
Relative attachment levelBaseline and 6 months post-surgery
RecessionBaseline and 6 months post-surgery
Intrabony defect fill percentageBaseline and 6 months post-surgery
Plaque indexBaseline and 6 months post-surgery.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026