- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594605
Applied The Platelet Rich Fibrin in Chronic Periodontitis
August 26, 2016 updated by: Alper KIZILDAĞ, Ataturk University
Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing
Platelet rich fibrin is a second generation platelet concentration which contains various growth factors.
The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing.
Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects.
Also PRF contains many growth factors.
PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration.
In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Denizli, Turkey, 20010
- Alper KIZILDAĞ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after Phase I therapy
Exclusion Criteria:
- The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Platelet Rich Fibrin
Platelet Rich Fibrin was applied with conventional flap surgery for treatment of periodontal bone loss in test group.
|
Platelet rich fibrin increases the growth factors.
So it was applied for treatment of periodontal bone loss.
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Active Comparator: Conventional Flap Surgery
Platelet Rich Fibrin was not applied to control groups.
Only conventional flap surgery was applied to control groups.
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Only Conventional Flap Surgery treatment the bone loss limitedly.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly
Time Frame: 4 weeks
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Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alteration of Clinical Attachment Level
Time Frame: 6 month
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Change from baseline Clinical Attachment Levels at 6 months were measured with periodontal probe.
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6 month
|
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Alteration of Periodontal Pocket Depth
Time Frame: 6 month
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Change from baseline Pocket Depth at 6 months were measured with periodontal probe.
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6 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yasin ÇİÇEK, Adiyaman University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.
- Kizildag A, Cicek Y, Arabaci T, Kose O. The effect of leukocyte-platelet-rich fibrin on bone morphogenetic protein-2 and insulin-like growth factor-1 levels in patients with chronic periodontitis: a randomized split mouth clinical trail. Growth Factors. 2018 Dec;36(5-6):239-245. doi: 10.1080/08977194.2018.1551217. Epub 2019 Jan 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 15, 2015
First Submitted That Met QC Criteria
November 2, 2015
First Posted (Estimate)
November 3, 2015
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
August 26, 2016
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 385/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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