A Phase 4 interventional study of Fotosan 630, CMS Dental, Copenhagen, Denmark and Scaling and root planing in Periodontal Diseases, Chronic Periodontitis and Periodontal Attachment Loss, sponsored by National University of Singapore. Completed. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by National University of Singapore · Phase 4, Interventional, and Treatment
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 27 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.
Device: Fotosan 630, CMS Dental, Copenhagen, Denmark
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
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 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.
Difference in percentage change in probing pocket depth
Time frame: 6 months
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
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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National University of Singapore