Photodynamic Therapy During Supportive Periodontal Therapy

January 27, 2016 updated by: Goh Xian Jun Edwin, National University, Singapore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photodynamic therapy protocol
In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in percentage change in probing pocket depth
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding on probing
Time Frame: 6 months
6 months
Clinical attachment level
Time Frame: 6 months
6 months
Recession
Time Frame: 6 months
6 months
Cytokines level
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-221-000-044-597

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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