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OpenTrials
Completed

NCT Number: NCT02666573

Photodynamic Therapy During Supportive Periodontal Therapy

27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received subgingival instrumentation and rubber cup polishing with pumice. In addition test sites received a single application of PDT using Fotosan® and photosensitizer consisting of toludine blue O solution. The subjects were recalled three and six months later and re-examined. Site level analysis was performed.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Good general health with no systemic diseases causing manifestation of periodontal diseases
  • Age ≥ 21 years
  • History of chronic periodontitis
  • At least two residual PPD ≥ 5 mm with or without bleeding on probing
  • Compliant with recalls, i.e. last SPT visit at most 6 months before start of trial
  • Able to give written informed consent

Exclusion criteria

  • Pregnant or lactating females
  • Local or systemic antibiotics intake in the past 3 months
  • Systemic conditions which could affect progression of periodontitis
  • Long term use of NSAIDs or immunosuppressive medications
  • Participation in other clinical trials

Treatment and study plan

Fotosan 630, CMS Dental, Copenhagen, Denmark

Device

The PDT system consists of a hand-held rechargeable light-emitting diode (LED) light source (Fotosan® 630 device, CMS Dental, Copenhagen, Denmark) and 0.1 mg/mL toluidine blue photosensitiser. The LED light source has a wavelength between 620 to 640 nm and peak of 630 nm and a power density between 2000 to 4000 mW/cm2.

Scaling and root planing

Other

Scaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste.

Primary outcomes

  1. Difference in percentage change in probing pocket depth

    Time frame: 6 months

Secondary outcomes

  1. Bleeding on probing

    Time frame: 6 months

  2. Clinical attachment level

    Time frame: 6 months

  3. Recession

    Time frame: 6 months

  4. Cytokines level

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study title

Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy

Important dates

Study start
2013
Primary completion
2014
First posted
Jan 28, 2016
Registry last updated
Jan 28, 2016

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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