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Completed

NCT Number: NCT03453476

Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

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.

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Key information

Conditions

Periodontitis, Adult Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRP and Fotosan 630

Device

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 names: Fotosan 630, CMS Dental, Copenhagen, Denmark

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2018
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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