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

NCT03027050 | Completed DMC

• 1 other identifier: BAP-2011301
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis; Periodontal Attachment Loss

Keywords

periodontitis; Growth factors; Periodontal healing

Outcome Measures

Primary Outcomes (1)

• Level of Growth Factor

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

  6 weeks

Secondary Outcomes (4)

• relative RANKL/OPG ratio in GCF

  6 weeks

• Alteration of Clinical Attachment Level

  9 months

• Alteration of Periodontal Pocket Depth

  9 months

• Gingival Margin Level

  9 months

Study Arms (2)

Titanium-prepared platelet rich fibrine

EXPERIMENTAL

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

Procedure: T-PRF; Procedure: Open Flap Debridement alone

Open Flap Debridement alone

ACTIVE COMPARATOR

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

Procedure: T-PRF; Procedure: Open Flap Debridement alone

Interventions

T-PRF PROCEDURE

Applied for treatment of periodontal bone loss.

Open Flap Debridement alone; Titanium-prepared platelet rich fibrine

Open Flap Debridement alone PROCEDURE

Open Flap Debridement alone; Titanium-prepared platelet rich fibrine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Related Publications (1)

• 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.

  PMID: 19228091 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Taner Arabacı

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share