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Photodynamic Therapy During Supportive Periodontal Therapy

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ClinicalTrials.gov Identifier: NCT02666573
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Goh Xian Jun Edwin, National University, Singapore

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE January 28, 2016
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Difference in percentage change in probing pocket depth [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Bleeding on probing [ Time Frame: 6 months ]
  • Clinical attachment level [ Time Frame: 6 months ]
  • Recession [ Time Frame: 6 months ]
  • Cytokines level [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy During Supportive Periodontal Therapy
Official Title  ICMJE Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Periodontal Diseases
  • Chronic Periodontitis
  • Periodontal Attachment Loss
Intervention  ICMJE
  • Device: Fotosan 630, CMS Dental, Copenhagen, Denmark
    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.
  • Other: Scaling and root planing
    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.
Study Arms  ICMJE
  • Experimental: Photodynamic therapy protocol
    In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.
    Intervention: Device: Fotosan 630, CMS Dental, Copenhagen, Denmark
  • SRP
    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.
    Intervention: Other: Scaling and root planing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2016)
27
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant or lactating females
  2. Local or systemic antibiotics intake in the past 3 months
  3. Systemic conditions which could affect progression of periodontitis
  4. Long term use of NSAIDs or immunosuppressive medications
  5. Participation in other clinical trials
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02666573
Other Study ID Numbers  ICMJE R-221-000-044-597
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Goh Xian Jun Edwin, National University, Singapore
Study Sponsor  ICMJE National University, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National University, Singapore
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP