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

Primary Purpose

Periodontitis, Periodontal Attachment Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
T-PRF
Open Flap Debridement alone
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, Growth factors, Periodontal healing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Titanium-prepared platelet rich fibrine

    Open Flap Debridement alone

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 17, 2017
    Last Updated
    January 19, 2017
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03027050
    Brief Title
    T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study
    Official Title
    T-PRF Contributes to Periodontal Healing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Periodontal Attachment Loss
    Keywords
    periodontitis, Growth factors, Periodontal healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Titanium-prepared platelet rich fibrine
    Arm Type
    Experimental
    Arm Description
    T-PRF was applied with open flap debridement in test group.
    Arm Title
    Open Flap Debridement alone
    Arm Type
    Active Comparator
    Arm Description
    T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.
    Intervention Type
    Procedure
    Intervention Name(s)
    T-PRF
    Intervention Description
    Applied for treatment of periodontal bone loss.
    Intervention Type
    Procedure
    Intervention Name(s)
    Open Flap Debridement alone
    Primary Outcome Measure Information:
    Title
    Level of Growth Factor
    Description
    Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    relative RANKL/OPG ratio in GCF
    Description
    Change in relative RANKL/OPG ratio from baseline to 6 weeks were measured by periopaper
    Time Frame
    6 weeks
    Title
    Alteration of Clinical Attachment Level
    Description
    Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
    Time Frame
    9 months
    Title
    Alteration of Periodontal Pocket Depth
    Description
    Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
    Time Frame
    9 months
    Title
    Gingival Margin Level
    Description
    Change from baseline to 9 months were measured with periodontal probe.
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Taner Arabacı
    Organizational Affiliation
    Ataturk University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19228091
    Citation
    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.
    Results Reference
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    T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study

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