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Clinical Trials/NCT03027050
NCT03027050CompletedNot Applicable

T-PRF Contributes to Periodontal Healing

Ataturk University0 sites33 target enrollmentStarted: November 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Primary Endpoint
Level of Growth Factor

Study Overview

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 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Titanium-prepared platelet rich fibrine

Experimental

T-PRF was applied with open flap debridement in test group.

Intervention: Open Flap Debridement alone (Procedure)

Titanium-prepared platelet rich fibrine

Experimental

T-PRF was applied with open flap debridement in test group.

Intervention: T-PRF (Procedure)

Open Flap Debridement alone

Active Comparator

T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.

Intervention: T-PRF (Procedure)

Open Flap Debridement alone

Active Comparator

T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.

Intervention: Open Flap Debridement alone (Procedure)

Outcomes

Primary Outcomes

Level of Growth Factor

Time Frame: 6 weeks

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

Secondary Outcomes

  • Alteration of Clinical Attachment Level(9 months)
  • Alteration of Periodontal Pocket Depth(9 months)
  • relative RANKL/OPG ratio in GCF(6 weeks)
  • Gingival Margin Level(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Taner ARABACI

Clinical Associate Professor

Ataturk University

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