Photodynamic Therapy During Supportive Periodontal Therapy

Phase 4

Completed

• Conditions: Chronic Periodontitis; Periodontal Attachment Loss; Periodontal Diseases
• Interventions: Device: Fotosan 630, CMS Dental, Copenhagen, Denmark; Other: Scaling and root planing

• Registration Number: NCT02666573
• Lead Sponsor: National University of Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-27
• Last Update Submitted: 2016-01-27
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Photodynamic therapy protocol	Fotosan 630, CMS Dental, Copenhagen, Denmark	In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.
SRP	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.

Primary Outcome Measures

Name	Time	Method
Difference in percentage change in probing pocket depth	6 months

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level	6 months
Recession	6 months
Bleeding on probing	6 months
Cytokines level	6 months