The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid (T-PRF)

The Effect of Titanium-Prepared Platelet-Rich Fibrin (T-PRF) Treatment on the Angiogenic Biomarkers in Gingival Crevicular Fluid (GCF) in Infrabony Defects of Patients With Chronic Periodontitis: A Randomized Controlled Clinical Trial

This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF) treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony defects of patients with chronic periodontitis. In each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+T-PRF).

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis; Intrabony Periodontal Defect
• Intervention / Treatment: Procedure: T-PRF; Procedure: Allograft

Detailed Description

Platelets are the cells initiating the wound healing and also supporting it by secreting various growth factors actively. These growth factors released by platelets act the increase of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound angiogenesis and the activation of macrophages by stimulating cell proliferation signals.

Titanium-prepared, platelet-rich fibrin (T-PRF), is a new platelet concentrate, is formed in titanium tubes may be more efficient to activate platelets in comparison with glass tubes.The titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical Diagnosis of Chronic Periodontitis
• The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy

Exclusion Criteria:

• Systemic illnesses
• Any medications known to affect the outcomes of periodontal surgery
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-PRF+Allograft; The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Test group sites were treated with T-PRF+allograft	Procedure: T-PRF; Flap Surgery; Procedure: Allograft; Flap Surgery
Experimental: Allograft; The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Control group sites were treated with only allograft	Procedure: Allograft; Flap Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Platelet-derived growth factor-BB (ng/µl) , vascular endothelial growth factor-A (ng/µl), fibroblast growth factor-2 (ng/µl), anjiogenin (ng/µl), angiostatin (ng/µl)	Within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
The Volume of Gingival Crevicular Fluid (microliter)	Within the first 30 days after surgery

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Angiogenesis; Bilateral infrabony defect; Flap surgery; Titanium-prepared, platelet-rich fibrin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: 2014/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No