NCT02898675

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

September 13, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

August 24, 2016

Last Update Submit

September 8, 2016

Conditions

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 (2)

  • Alteration of Clinical Attachment Level

    9 month

  • Alteration of Periodontal Pocket Depth

    9 month

Study Arms (2)

Platelet Rich Fibrine

EXPERIMENTAL

Platelet Rich Fibrine was applied with open flap debridement in test group.

Device: Platelet rich fibrine

Open Flap Debridement

ACTIVE COMPARATOR

Platelet Rich Fibrin was not applied to control groups. Only open flap debridement was applied to control groups.

Device: Open Flap Debridement

Interventions

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

Platelet Rich Fibrine

Only open flap debridement treatment the bone loss limitedly

Open Flap Debridement

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 19228091BACKGROUND
  • Arabaci T, Kose O, Albayrak M, Cicek Y, Kizildag A. Advantages of Autologous Platelet-Rich Fibrin Membrane on Gingival Crevicular Fluid Growth Factor Levels and Periodontal Healing: A Randomized Split-Mouth Clinical Study. J Periodontol. 2017 Aug;88(8):771-777. doi: 10.1902/jop.2017.160485. Epub 2017 Apr 28.

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yasin ÇİÇEK

    Adiyaman University

    STUDY CHAIR

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

August 24, 2016

First Posted

September 13, 2016

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

May 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-08