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Photodynamic Therapy During Supportive Periodontal Therapy

Primary Purpose

Periodontal Diseases, Chronic Periodontitis, Periodontal Attachment Loss

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Fotosan 630, CMS Dental, Copenhagen, Denmark

Scaling and root planing

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring drug therapy, Photosensitizing Agents, therapeutic use

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Photodynamic therapy protocol

SRP

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Difference in percentage change in probing pocket depth

Secondary Outcome Measures

Bleeding on probing

Clinical attachment level

Recession

Cytokines level

Full Information

NCT ID

NCT02666573

First Posted

January 25, 2016

Last Updated

January 27, 2016

Sponsor

National University of Singapore

1. Study Identification

Unique Protocol Identification Number

NCT02666573

Brief Title

Photodynamic Therapy During Supportive Periodontal Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Singapore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases, Chronic Periodontitis, Periodontal Attachment Loss

Keywords

drug therapy, Photosensitizing Agents, therapeutic use

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Photodynamic therapy protocol

Arm Type

Experimental

Arm Description

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

Arm Title

SRP

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Fotosan 630, CMS Dental, Copenhagen, Denmark

Intervention Description

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

Other

Intervention Name(s)

Scaling and root planing

Intervention Description

Primary Outcome Measure Information:

Title

Difference in percentage change in probing pocket depth

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Bleeding on probing

Time Frame

6 months

Title

Clinical attachment level

Time Frame

6 months

Title

Recession

Time Frame

6 months

Title

Cytokines level

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy During Supportive Periodontal Therapy

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