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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02218515 |
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Date of registration:
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11/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft
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Scientific title:
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Evaluation of Gingival Crevicular Fluid Transforming Growth Factor-ß1 Level After Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02218515 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Bahar Kuru, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Marmara University, Faculty of Dentistry, Department of Periodontology |
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Name:
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Ömer Birkan Agrali, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Marmara University Faculty of Dentistry, Department of Periodontology |
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Name:
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Leyla Kuru, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Marmara University, Faculty of Dentistry, Department of Periodontology |
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Key inclusion & exclusion 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)
Age minimum:
32 Years
Age maximum:
57 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periodontal Bone Loss
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Chronic Periodontitis
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Intervention(s)
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Biological: Emdogain?(Enamel Matrix Derivative)
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Procedure: Open Flap Debridement
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Biological: Emdogain?Enamel Matrix Derivative+Autogenous Bone
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Primary Outcome(s)
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Attachment Gain
[Time Frame: 6 months after surgery]
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Secondary Outcome(s)
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Gingival crevicular fluid TGF-ß1 level
[Time Frame: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery]
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Secondary ID(s)
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SAG-C-DRP-090909-0288
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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