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

Sponsor

Ataturk University (Other)

Overall Status

Completed

CT.gov ID

NCT03027050

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Periodontal Attachment Loss	Procedure: T-PRF Procedure: Open Flap Debridement alone	N/A

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

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

T-PRF Contributes to Periodontal Healing

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Level of Growth Factor [6 weeks]
Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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