Chronic Periodontitis Clinical Trial
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
Verified date | August 2014 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 32 Years to 57 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University Faculty of Dentistry, Department of Periodontology | Istanbul | Sisli/Nisantasi |
Lead Sponsor | Collaborator |
---|---|
Haner Direskeneli, Prof |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plaque index | Baseline and 6 months post-surgery. | Yes | |
Other | Gingival index | Baseline and 6 months post-surgery | Yes | |
Other | Bleeding on probing | Baseline and 6 months post-surgery | Yes | |
Other | Probing depth | Baseline and 6 months post-surgery | Yes | |
Other | Relative attachment level | Baseline and 6 months post-surgery | Yes | |
Other | Recession | Baseline and 6 months post-surgery | Yes | |
Other | Intrabony defect fill percentage | Baseline and 6 months post-surgery | Yes | |
Primary | Attachment Gain | 6 months after surgery | Yes | |
Secondary | Gingival crevicular fluid TGF-ß1 level | 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery | Yes |
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