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Photodynamic Therapy During Supportive Periodontal Therapy

N

National University of Singapore

Status and phase

Completed
Phase 4

Conditions

Periodontal Attachment Loss
Periodontal Diseases
Chronic Periodontitis

Treatments

Device: Fotosan 630, CMS Dental, Copenhagen, Denmark
Other: Scaling and root planing

Study type

Interventional

Funder types

Other

Identifiers

NCT02666573
R-221-000-044-597

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Photodynamic therapy protocol
Experimental group
Description:
In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.
Treatment:
Device: Fotosan 630, CMS Dental, Copenhagen, Denmark
SRP
Other group
Description:
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.
Treatment:
Other: Scaling and root planing

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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