Photodynamic Therapy During Supportive Periodontal Therapy

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666573
• Other study ID #: R-221-000-044-597
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2016
• Last updated: January 27, 2016
• Start date: June 2013

Study information

• Verified date: January 2016
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Attachment Loss
• Periodontal Diseases
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in percentage change in probing pocket depth		6 months
Secondary	Bleeding on probing		6 months
Secondary	Clinical attachment level		6 months
Secondary	Recession		6 months
Secondary	Cytokines level		6 months