Photodynamic Therapy During Supportive Periodontal Therapy

NCT ID: NCT02666573

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30

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.

Conditions

Periodontal Diseases; Chronic Periodontitis; Periodontal Attachment Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photodynamic therapy protocol

In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.

Group Type: EXPERIMENTAL

Fotosan 630, CMS Dental, Copenhagen, Denmark

Intervention Type: DEVICE

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.

Group Type: OTHER

Scaling and root planing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Goh Xian Jun Edwin

Periodontology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

R-221-000-044-597

Identifier Type: -

Identifier Source: org_study_id