Photodynamic Therapy During Supportive Periodontal Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontal Diseases, Chronic Periodontitis, Periodontal Attachment Loss

Intervention / Treatment
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* Device: Fotosan 630, CMS Dental, Copenhagen, Denmark
* Other: Scaling and root planing


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photodynamic therapy protocol<br>In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions. | Device: Fotosan 630, CMS Dental, Copenhagen, Denmark<br>* 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.<br>|
| Other: SRP<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in percentage change in probing pocket depth |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing |  | 6 months | 
| Clinical attachment level |  | 6 months | 
| Recession |  | 6 months | 
| Cytokines level |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug therapy, Photosensitizing Agents, therapeutic use