T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study

T-PRF Contributes to Periodontal Healing

It was aimed to evaluate the contributions of T-PRF treatment combined with open flap debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis patients. 29 patients (58 sites) with chronic periodontitis were treated either with autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG ratio at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such as probing depth (PD), relative attachment level (RAL) and gingival margin level (GML) at baseline and 9 months after surgery were compromised.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Attachment Loss
• Intervention / Treatment: Procedure: T-PRF; Procedure: Open Flap Debridement alone

Detailed Description

A total of 29 medically healthy patients (12 females and 17 males; age range 28-49 years, mean±SD: 38.22±8.21) with chronic periodontitis at the outpatient Ataturk University, Department of Periodontology, Faculty of Dentistry, Erzurum, Turkey, were selected for the study. The study, conducted from November 2015 to June 2016, was planned as a randomized, double-blinded, controlled clinical trial that used a split-mouth design. This study was proved by the ethics committee of Ataturk University Faculty of Dentistry, and all patients received verbal information regarding participation and provided written informed consent for including to the study.

Bone loss characteristics of the patients were diagnosed with full-mouth radiographs and cone-beam computed tomography. This study included the patients with moderate-to-severe chronic periodontitis with a probing depth of 5 mm or deeper and horizontal bone loss (one- or two-wall shallow interproximal defects) of at least two quadrants of the jaws after Phase-I periodontal therapy. After re-evaluating the results of Phase-I therapy, patients with any of the following were excluded from the study: 1) smoking or tobacco use in any form; 2) medications known to affect periodontal treatment and blood coagulation; 3) systemic conditions known to affect periodontal status; 4) pregnancy/lactation; and 5) poor oral hygiene (plaque index [PI] >1.5) (Sillness and Loe; 1964). Patients with teeth with 3-wall intrabony defects, gingival recession, endodontic lesion, or furcation involvement were also excluded.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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: Titanium-prepared platelet rich fibrine; T-PRF was applied with open flap debridement in test group.	Procedure: T-PRF; Applied for treatment of periodontal bone loss.; Procedure: Open Flap Debridement alone
Active Comparator: Open Flap Debridement alone; T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.	Procedure: T-PRF; Applied for treatment of periodontal bone loss.; Procedure: Open Flap Debridement alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Growth Factor	Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relative RANKL/OPG ratio in GCF	Change in relative RANKL/OPG ratio from baseline to 6 weeks were measured by periopaper	6 weeks
Alteration of Clinical Attachment Level	Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.	9 months
Alteration of Periodontal Pocket Depth	Change from baseline Pocket Depth at 9 months were measured with periodontal probe.	9 months
Gingival Margin Level	Change from baseline to 9 months were measured with periodontal probe.	9 months

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: Taner Arabacı, Ataturk University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: periodontitis; Growth factors; Periodontal healing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Periodontitis; Periodontal Attachment Loss
• Other Study ID Numbers: BAP-2011301

Plan for Individual participant data (IPD)

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