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Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients

Primary Purpose

Periodontitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRF
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: •periodontitis Exclusion Criteria: Periodontal therapy for the last 3 months Medical history of systemic diseases such as diabetes. Patients wearing dental prosthesis Alcoholic patients Teeth with grade II mobility, endodontic lesions, and teeth with untreated caries

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Test ScRp+PRF

    Control ScRp

    Arm Description

    This site will treated by ScRp+PRF

    This site will treated by ScRp only

    Outcomes

    Primary Outcome Measures

    Change in Clinical attachment level
    Using UNC-15 periodontal probe measured in mm
    Change in Periodontal pocket depth measured in mm
    Using UNC-15 periodontal probe measured in mm

    Secondary Outcome Measures

    Change in plaque index
    Using Sinless and Loe 1964 plaque index scores
    Change in bleeding on probing percentage
    Using UNC-15 periodontal probe
    Change in GCF level of platelet derived growth factor
    Using periocol paper to collect GCF and analysed by ELISA test

    Full Information

    First Posted
    May 16, 2023
    Last Updated
    May 25, 2023
    Sponsor
    University of Baghdad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05890157
    Brief Title
    Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients
    Official Title
    Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Platelet rich fibrin (PRF) has been widely used in regenerative dentistry since it provides plenty amount of growth factors that enhance wound healing and tissue regeneration. Platelet derived growth factor-BB (PDGF-BB) is a growth factor with essential functions such as regulation of cell migration, proliferation, and differentiation. This study aims to evaluate the efficacy of PRF in improving the clinical periodontal parameters and GCF level of PDGF-BB.
    Detailed Description
    Split mouth randomized clinical trial is the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets will be designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites were treated by scaling and root planing only. Clinal periodontal parameters were recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Test ScRp+PRF
    Arm Type
    Experimental
    Arm Description
    This site will treated by ScRp+PRF
    Arm Title
    Control ScRp
    Arm Type
    No Intervention
    Arm Description
    This site will treated by ScRp only
    Intervention Type
    Other
    Intervention Name(s)
    PRF
    Intervention Description
    Split mouth randomized clinical trial will be the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets were designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites will be treated by scaling and root planing only. Clinal periodontal parameters will be recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.
    Primary Outcome Measure Information:
    Title
    Change in Clinical attachment level
    Description
    Using UNC-15 periodontal probe measured in mm
    Time Frame
    Change from baseline to 1-month and change from baseline to 3-month
    Title
    Change in Periodontal pocket depth measured in mm
    Description
    Using UNC-15 periodontal probe measured in mm
    Time Frame
    Change from baseline to 1-month and change from baseline to 3-month
    Secondary Outcome Measure Information:
    Title
    Change in plaque index
    Description
    Using Sinless and Loe 1964 plaque index scores
    Time Frame
    Change from baseline to 1-month and change from baseline to 3-month
    Title
    Change in bleeding on probing percentage
    Description
    Using UNC-15 periodontal probe
    Time Frame
    Change from baseline to 1-month and change from baseline to 3-month
    Title
    Change in GCF level of platelet derived growth factor
    Description
    Using periocol paper to collect GCF and analysed by ELISA test
    Time Frame
    Change from baseline to 1-month and change from baseline to 3-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: •periodontitis Exclusion Criteria: Periodontal therapy for the last 3 months Medical history of systemic diseases such as diabetes. Patients wearing dental prosthesis Alcoholic patients Teeth with grade II mobility, endodontic lesions, and teeth with untreated caries

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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