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Completed

NCT Number: NCT03027050

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-PRF

Procedure

Applied for treatment of periodontal bone loss.

Open Flap Debridement alone

Procedure

Primary outcomes

  1. 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

  1. 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

  2. Alteration of Clinical Attachment Level

    Time frame: 9 months

    Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.

  3. Alteration of Periodontal Pocket Depth

    Time frame: 9 months

    Change from baseline Pocket Depth at 9 months were measured with periodontal probe.

  4. Gingival Margin Level

    Time frame: 9 months

    Change from baseline to 9 months were measured with periodontal probe.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

T-PRF Contributes to Periodontal Healing

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2017
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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