Applied The Platelet Rich Fibrin in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594605
• Other study ID #: 385/2012
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2015
• Last updated: August 26, 2016
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Device:
• Platelet Rich Fibrin
Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.
• Conventional Flap Surgery
Only Conventional Flap Surgery treatment the bone loss limitedly.

Locations

Country	Name	City	State
Turkey	Alper KIZILDAG	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	Alteration of Clinical Attachment Level	Change from baseline Clinical Attachment Levels at 6 months were measured with periodontal probe.	6 month	No
Secondary	Alteration of Periodontal Pocket Depth	Change from baseline Pocket Depth at 6 months were measured with periodontal probe.	6 month	No