search
Back to results

Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

Primary Purpose

CHRONIC PERIODONTITIS

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo gel
Hyaluronic acid gel
Platelet rich fibrin
Sponsored by
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CHRONIC PERIODONTITIS

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients are in general good health.
  • Patients having minimum of 20 permanent teeth.
  • They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
  • Presence of periodontal pockets (≥5 mm) and clinicala ttachment level > 5 mm.

Exclusion Criteria:

  • Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
  • Clotting and Hematological disorders
  • Patients with grade III mobility.
  • Patients with smoking and alcohol consuming habit.
  • Pregnant and lactating female.
  • Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)
  • The teeth with poor filling and ill fitted restorations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Negative control

    Test group 1

    Test group 2

    Arm Description

    Placebo gel

    Hyaluronic acid gel

    injectable prf

    Outcomes

    Primary Outcome Measures

    Clinical attachment level (CAL)
    Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")

    Secondary Outcome Measures

    Probing pocket depth
    Measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")

    Full Information

    First Posted
    August 23, 2019
    Last Updated
    August 26, 2019
    Sponsor
    Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04070729
    Brief Title
    Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy
    Official Title
    Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 28, 2019 (Anticipated)
    Primary Completion Date
    November 28, 2019 (Anticipated)
    Study Completion Date
    January 25, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid. 120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.
    Detailed Description
    The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CHRONIC PERIODONTITIS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Negative control
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo gel
    Arm Title
    Test group 1
    Arm Type
    Experimental
    Arm Description
    Hyaluronic acid gel
    Arm Title
    Test group 2
    Arm Type
    Experimental
    Arm Description
    injectable prf
    Intervention Type
    Other
    Intervention Name(s)
    Placebo gel
    Other Intervention Name(s)
    Cellulose gel
    Intervention Description
    Localized subgingival application
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic acid gel
    Intervention Description
    Localized subgingival application
    Intervention Type
    Biological
    Intervention Name(s)
    Platelet rich fibrin
    Intervention Description
    Localized subgingival application
    Primary Outcome Measure Information:
    Title
    Clinical attachment level (CAL)
    Description
    Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
    Time Frame
    3 Months
    Secondary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    Measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
    Time Frame
    3 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients are in general good health. Patients having minimum of 20 permanent teeth. They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months. Presence of periodontal pockets (≥5 mm) and clinicala ttachment level > 5 mm. Exclusion Criteria: Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.) Clotting and Hematological disorders Patients with grade III mobility. Patients with smoking and alcohol consuming habit. Pregnant and lactating female. Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use) The teeth with poor filling and ill fitted restorations

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

    We'll reach out to this number within 24 hrs