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Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

Primary Purpose

Periodontitis, Adult, Periodontal Pocket, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SRP and Fotosan 630
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Adult focused on measuring Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults who were medically fit or have medical condition that did not alter the outcome of periodontal treatment.
  • Females who were not pregnant or nursing.
  • Controlled diabetes mellitus with HbA1c < 7.5 mmol/L.
  • Not on any antibiotics or steroids 3 months prior to periodontal treatment.
  • Diagnosed to have either localized or generalized chronic or aggressive periodontitis (Armitage, 1999) with all 4 quadrants having at least 2 sites with probing depth ≥ 4 mm.
  • Consented to follow the non-surgical periodontal treatment (scaling and root planing) with PDT throughout the period of study, i.e. approximately 6 months.

Exclusion Criteria:

  • Allergic to photosensitizer or dye
  • Pregnant lady and nursing mothers
  • Uncontrolled diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SRP and Fotosan 630

    Control

    Arm Description

    Scaling and root planing, photodynamic therapy using Fotosan 630

    Scaling and root planing only

    Outcomes

    Primary Outcome Measures

    Changes from baseline probing depth at 3rd month and 6th month
    Clinical probing depth in mm
    Changes from baseline clinical attachment level at 3rd month and 6th month
    Clinical attachment level in mm
    Changes from baseline gingival recession level at 3rd month and 6th month
    Gingival recession level in mm
    Changes from baseline bleeding score at 3rd month and 6th month
    Bleeding score in percentage
    Changes from baseline Interleukin-1 level at 3rd month and 6th month
    Interleukin-1 level in gingival crevicular fluid
    Changes from baseline Interleukin-6 level at 3rd month and 6th month
    Interlekin-6 level in gingival crevicular fluid
    Changes from baseline Interleukin-8 level at 3rd month and 6th month
    Interleukin-8 level in gingival crevicular fluid
    Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month
    Tumour necrosis factor-alpha level in gingival crevicular fluid
    Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month
    Matrix metalloproteinase-8 level in gingival crevicular fluid

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2018
    Last Updated
    February 26, 2018
    Sponsor
    National University of Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03453476
    Brief Title
    Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
    Official Title
    Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2012 (Actual)
    Primary Completion Date
    March 31, 2013 (Actual)
    Study Completion Date
    June 30, 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Systemically healthy periodontitis patients were recruited in this single-blind, split-mouth, randomized controlled clinical trial. After SRP, PDT was applied at probing depth (PD) ≥ 4 mm at test quadrant. At baseline, 3rd month and 6th month, clinical parameters and cytokine pattern in gingival crevicular fluids (GCFs) were analysed.
    Detailed Description
    Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Adult, Periodontal Pocket, Periodontitis, Periodontal Attachment Loss
    Keywords
    Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Split-mouth design
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Allocation of test and control quadrants were done randomly by asking each study participant to choose either numbers "1" or "2". Number "1" defined quadrants 1 and 3 as the test quadrants while number "2" referred to quadrants 2 and 4 as the test quadrants. The remaining quadrants served as the control quadrants.
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SRP and Fotosan 630
    Arm Type
    Experimental
    Arm Description
    Scaling and root planing, photodynamic therapy using Fotosan 630
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Scaling and root planing only
    Intervention Type
    Device
    Intervention Name(s)
    SRP and Fotosan 630
    Other Intervention Name(s)
    Fotosan 630, CMS Dental, Copenhagen, Denmark
    Intervention Description
    After isolating the test quadrants with cotton roll, toluidine blue was applied into the deep pockets (PD ≥ 4mm) at the test quadrants for 10 seconds, followed by inserting a perio tip (15 or 21 mm depending on the depth of the pocket) that connected to a LED emitting device, and light was emitted for 20 seconds. Toluidine blue in the deep pocket was removed by injecting normal saline into the pocket.
    Primary Outcome Measure Information:
    Title
    Changes from baseline probing depth at 3rd month and 6th month
    Description
    Clinical probing depth in mm
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline clinical attachment level at 3rd month and 6th month
    Description
    Clinical attachment level in mm
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline gingival recession level at 3rd month and 6th month
    Description
    Gingival recession level in mm
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline bleeding score at 3rd month and 6th month
    Description
    Bleeding score in percentage
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline Interleukin-1 level at 3rd month and 6th month
    Description
    Interleukin-1 level in gingival crevicular fluid
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline Interleukin-6 level at 3rd month and 6th month
    Description
    Interlekin-6 level in gingival crevicular fluid
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline Interleukin-8 level at 3rd month and 6th month
    Description
    Interleukin-8 level in gingival crevicular fluid
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month
    Description
    Tumour necrosis factor-alpha level in gingival crevicular fluid
    Time Frame
    3 months and 6 months
    Title
    Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month
    Description
    Matrix metalloproteinase-8 level in gingival crevicular fluid
    Time Frame
    3 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults who were medically fit or have medical condition that did not alter the outcome of periodontal treatment. Females who were not pregnant or nursing. Controlled diabetes mellitus with HbA1c < 7.5 mmol/L. Not on any antibiotics or steroids 3 months prior to periodontal treatment. Diagnosed to have either localized or generalized chronic or aggressive periodontitis (Armitage, 1999) with all 4 quadrants having at least 2 sites with probing depth ≥ 4 mm. Consented to follow the non-surgical periodontal treatment (scaling and root planing) with PDT throughout the period of study, i.e. approximately 6 months. Exclusion Criteria: Allergic to photosensitizer or dye Pregnant lady and nursing mothers Uncontrolled diabetes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lum Peng Lim
    Organizational Affiliation
    Faculty of Dentistry, National University of Singapore
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

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