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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: T-PRF Contributes to Periodontal Healing

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Ataturk University

Current Primary Outcome: Level of Growth Factor [ Time Frame: 6 weeks ]

Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Ataturk University

Dates:
Date Received: January 17, 2017
Date Started: November 2015
Date Completion:
Last Updated: January 19, 2017
Last Verified: January 2017