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Applied The Platelet Rich Fibrin in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02594605
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Alper KIZILDAĞ, Ataturk University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Device: Platelet Rich Fibrin Device: Conventional Flap Surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing
Study Start Date : December 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

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.
Device: Platelet Rich Fibrin
Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.

Active Comparator: Conventional Flap Surgery
Platelet Rich Fibrin was not applied to control groups. Only conventional flap surgery was applied to control groups.
Device: Conventional Flap Surgery
Only Conventional Flap Surgery treatment the bone loss limitedly.




Primary Outcome Measures :
  1. Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly [ Time Frame: 4 weeks ]
    Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.


Secondary Outcome Measures :
  1. Alteration of Clinical Attachment Level [ Time Frame: 6 month ]
    Change from baseline Clinical Attachment Levels at 6 months were measured with periodontal probe.

  2. Alteration of Periodontal Pocket Depth [ Time Frame: 6 month ]
    Change from baseline Pocket Depth at 6 months were measured with periodontal probe.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594605


Locations
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Turkey
Alper KIZILDAĞ
Denizli, Turkey, 20010
Sponsors and Collaborators
Ataturk University
Investigators
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Study Chair: Yasin ÇiÇEK Adıyaman University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alper KIZILDAĞ, Health Sciences Institute, Ataturk University
ClinicalTrials.gov Identifier: NCT02594605     History of Changes
Other Study ID Numbers: 385/2012
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: December 2012

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases