Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet rich fibrine
Open Flap Debridement
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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 initial treatment
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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet Rich Fibrine
Open Flap Debridement
Arm Description
Platelet Rich Fibrine was applied with open flap debridement in test group.
Platelet Rich Fibrin was not applied to control groups. Only open flap debridement was applied to control groups.
Outcomes
Primary Outcome Measures
Level of Growth Factor
Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
Secondary Outcome Measures
Alteration of Clinical Attachment Level
Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
Alteration of Periodontal Pocket Depth
Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02898675
Brief Title
Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing
Official Title
Investigation of the Contributions of Platelet Rich Fibrin Combined With Open Flap Debridement on Periodontal Healing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
May 2016 (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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Fibrine
Arm Type
Experimental
Arm Description
Platelet Rich Fibrine was applied with open flap debridement in test group.
Arm Title
Open Flap Debridement
Arm Type
Active Comparator
Arm Description
Platelet Rich Fibrin was not applied to control groups. Only open flap debridement was applied to control groups.
Intervention Type
Device
Intervention Name(s)
Platelet rich fibrine
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)
Open Flap Debridement
Intervention Description
Only open flap debridement treatment the bone loss limitedly
Primary Outcome Measure Information:
Title
Level of Growth Factor
Description
Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Alteration of Clinical Attachment Level
Description
Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
Time Frame
9 month
Title
Alteration of Periodontal Pocket Depth
Description
Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
Time Frame
9 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 initial treatment
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 ÇİÇEK
Organizational Affiliation
Adiyaman University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
19228091
Citation
Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.
Results Reference
background
PubMed Identifier
28452623
Citation
Arabaci T, Kose O, Albayrak M, Cicek Y, Kizildag A. Advantages of Autologous Platelet-Rich Fibrin Membrane on Gingival Crevicular Fluid Growth Factor Levels and Periodontal Healing: A Randomized Split-Mouth Clinical Study. J Periodontol. 2017 Aug;88(8):771-777. doi: 10.1902/jop.2017.160485. Epub 2017 Apr 28.
Results Reference
derived
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Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing
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