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Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

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ClinicalTrials.gov Identifier: NCT03453476
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Foo Lean Heong, National University, Singapore

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.

Condition or disease Intervention/treatment Phase
Periodontitis, Adult Periodontal Pocket Periodontitis Periodontal Attachment Loss Device: SRP and Fotosan 630 Not Applicable

Detailed Description:
Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-mouth design
Masking: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
Official Title: Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : March 31, 2013
Actual Study Completion Date : June 30, 2013

Arm Intervention/treatment
Experimental: SRP and Fotosan 630
Scaling and root planing, photodynamic therapy using Fotosan 630
Device: SRP and Fotosan 630
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.
Other Name: Fotosan 630, CMS Dental, Copenhagen, Denmark

No Intervention: Control
Scaling and root planing only



Primary Outcome Measures :
  1. Changes from baseline probing depth at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Clinical probing depth in mm

  2. Changes from baseline clinical attachment level at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Clinical attachment level in mm

  3. Changes from baseline gingival recession level at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Gingival recession level in mm

  4. Changes from baseline bleeding score at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Bleeding score in percentage

  5. Changes from baseline Interleukin-1 level at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Interleukin-1 level in gingival crevicular fluid

  6. Changes from baseline Interleukin-6 level at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Interlekin-6 level in gingival crevicular fluid

  7. Changes from baseline Interleukin-8 level at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Interleukin-8 level in gingival crevicular fluid

  8. Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Tumour necrosis factor-alpha level in gingival crevicular fluid

  9. Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month [ Time Frame: 3 months and 6 months ]
    Matrix metalloproteinase-8 level in gingival crevicular fluid



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453476


Sponsors and Collaborators
National University, Singapore
Investigators
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Study Director: Lum Peng Lim Faculty of Dentistry, National University of Singapore

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Responsible Party: Foo Lean Heong, Periodontic Resident, Faculty of Dentistry, National University, Singapore
ClinicalTrials.gov Identifier: NCT03453476     History of Changes
Other Study ID Numbers: NUSingapore
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foo Lean Heong, National University, Singapore:
Photodynamic therapy
Interleukin 1-beta
Tumour necrosis factor - alpha
Interleukin-6
Interleukin-8
Matrix metalloproteinase-8
Additional relevant MeSH terms:
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Periodontitis
Periodontal Pocket
Periodontal Attachment Loss
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy