Applied The Platelet Rich Fibrin in Chronic Periodontitis

NCT02594605 | Completed Phase 2 DMC

• 1 other identifier: 385/2012
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly

  Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.

  4 weeks

Secondary Outcomes (2)

• Alteration of Clinical Attachment Level

  6 month

• Alteration of Periodontal Pocket Depth

  6 month

Study Arms (2)

Platelet Rich Fibrin

EXPERIMENTAL

Platelet Rich Fibrin was applied with conventional flap surgery for treatment of periodontal bone loss in test group.

Device: Platelet Rich Fibrin

Conventional Flap Surgery

ACTIVE COMPARATOR

Platelet Rich Fibrin was not applied to control groups. Only conventional flap surgery was applied to control groups.

Device: Conventional Flap Surgery

Interventions

Platelet Rich Fibrin DEVICE

Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.

Platelet Rich Fibrin

Conventional Flap Surgery DEVICE

Only Conventional Flap Surgery treatment the bone loss limitedly.

Conventional Flap Surgery

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 Phase I therapy

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

Study Sites (1)

Alper KIZILDAĞ

Denizli, Denizli, 20010, Turkey (Türkiye)

Location

Related Publications (2)

• Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.

  PMID: 19878476 BACKGROUND

• Kizildag A, Cicek Y, Arabaci T, Kose O. The effect of leukocyte-platelet-rich fibrin on bone morphogenetic protein-2 and insulin-like growth factor-1 levels in patients with chronic periodontitis: a randomized split mouth clinical trail. Growth Factors. 2018 Dec;36(5-6):239-245. doi: 10.1080/08977194.2018.1551217. Epub 2019 Jan 9.

  PMID: 30624092 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasin ÇiÇEK

  Adiyaman University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Institute

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: November 3, 2015
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 29, 2016

Record last verified: 2012-12

Locations

TU (1)