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Applied The Platelet Rich Fibrin in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Platelet Rich Fibrin
Conventional Flap Surgery
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alper KIZILDAĞ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet Rich Fibrin

Conventional Flap Surgery

Arm Description

Platelet Rich Fibrin was applied with conventional flap surgery for treatment of periodontal bone loss in test group.

Platelet Rich Fibrin was not applied to control groups. Only conventional flap surgery was applied to control groups.

Outcomes

Primary Outcome Measures

Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly
Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.

Secondary Outcome Measures

Alteration of Clinical Attachment Level
Change from baseline Clinical Attachment Levels at 6 months were measured with periodontal probe.
Alteration of Periodontal Pocket Depth
Change from baseline Pocket Depth at 6 months were measured with periodontal probe.

Full Information

First Posted
October 15, 2015
Last Updated
August 26, 2016
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT02594605
Brief Title
Applied The Platelet Rich Fibrin in Chronic Periodontitis
Official Title
Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet Rich Fibrin
Arm Type
Experimental
Arm Description
Platelet Rich Fibrin was applied with conventional flap surgery for treatment of periodontal bone loss in test group.
Arm Title
Conventional Flap Surgery
Arm Type
Active Comparator
Arm Description
Platelet Rich Fibrin was not applied to control groups. Only conventional flap surgery was applied to control groups.
Intervention Type
Device
Intervention Name(s)
Platelet Rich Fibrin
Intervention Description
Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.
Intervention Type
Device
Intervention Name(s)
Conventional Flap Surgery
Intervention Description
Only Conventional Flap Surgery treatment the bone loss limitedly.
Primary Outcome Measure Information:
Title
Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly
Description
Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Alteration of Clinical Attachment Level
Description
Change from baseline Clinical Attachment Levels at 6 months were measured with periodontal probe.
Time Frame
6 month
Title
Alteration of Periodontal Pocket Depth
Description
Change from baseline Pocket Depth at 6 months were measured with periodontal probe.
Time Frame
6 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasin ÇiÇEK
Organizational Affiliation
Adiyaman University
Official's Role
Study Chair
Facility Information:
Facility Name
Alper KIZILDAĞ
City
Denizli
ZIP/Postal Code
20010
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19878476
Citation
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.
Results Reference
background
PubMed Identifier
30624092
Citation
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.
Results Reference
derived

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Applied The Platelet Rich Fibrin in Chronic Periodontitis

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