Photodynamic Therapy During Supportive Periodontal Therapy

NCT02666573 | Completed Phase 4

• 1 other identifier: R-221-000-044-597
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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

Keywords

drug therapy; Photosensitizing Agents; therapeutic use

Outcome Measures

Primary Outcomes (1)

• Difference in percentage change in probing pocket depth

  6 months

Secondary Outcomes (4)

• Bleeding on probing

  6 months

• Clinical attachment level

  6 months

• Recession

  6 months

• Cytokines level

  6 months

Study Arms (2)

Photodynamic therapy protocol

EXPERIMENTAL

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

Device: Fotosan 630, CMS Dental, Copenhagen, Denmark

SRP

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.

Other: Scaling and root planing

Interventions

Fotosan 630, CMS Dental, Copenhagen, Denmark 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.

Photodynamic therapy protocol

Scaling and root planing 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.

SRP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis; Periodontal Attachment Loss

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontology Resident

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: January 28, 2016

Record last verified: 2016-01