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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

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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Chronic Periodontitis Periodontal Attachment Loss Device: Fotosan 630, CMS Dental, Copenhagen, Denmark Other: Scaling and root planing Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy
Study Start Date : June 2013
Actual Primary Completion Date : December 2014

Arm Intervention/treatment
Experimental: Photodynamic therapy protocol
In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.
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.

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.
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.




Primary Outcome Measures :
  1. Difference in percentage change in probing pocket depth [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Goh Xian Jun Edwin, Periodontology Resident, National University, Singapore
ClinicalTrials.gov Identifier: NCT02666573     History of Changes
Other Study ID Numbers: R-221-000-044-597
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Goh Xian Jun Edwin, National University, Singapore:
drug therapy
Photosensitizing Agents
therapeutic use

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Periodontal Attachment Loss
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy