Chronic Periodontitis, Periodontal Attachment Loss, Periodontal Diseases
Conditions
Keywords
drug therapy, Photosensitizing Agents, therapeutic use
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.
Interventions
DEVICEFotosan 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.
OTHERScaling 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.
Sponsors
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in percentage change in probing pocket depth | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding on probing | 6 months |
| Clinical attachment level | 6 months |
| Recession | 6 months |
| Cytokines level | 6 months |
Outcome results
None listed