Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898675
• Other study ID #: BAP-2011300
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: September 8, 2016
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• 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: 26
• Est. completion date: May 2016
• Est. primary completion date: June 2015
• 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 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Device:
• Platelet rich fibrine
Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.
• Open Flap Debridement
Only open flap debridement treatment the bone loss limitedly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

References & Publications (1)

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 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Growth Factor	Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper	6 weeks	No
Secondary	Alteration of Clinical Attachment Level	Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.	9 month	No
Secondary	Alteration of Periodontal Pocket Depth	Change from baseline Pocket Depth at 9 months were measured with periodontal probe.	9 month	No