Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

Systemically healthy periodontitis patients were recruited in this single-blind, split-mouth, randomized controlled clinical trial. After SRP, PDT was applied at probing depth (PD) ≥ 4 mm at test quadrant. At baseline, 3rd month and 6th month, clinical parameters and cytokine pattern in gingival crevicular fluids (GCFs) were analysed.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Pocket; Periodontal Attachment Loss; Periodontitis, Adult
• Intervention / Treatment: Device: SRP and Fotosan 630

Detailed Description

Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults who were medically fit or have medical condition that did not alter the outcome of periodontal treatment.
• Females who were not pregnant or nursing.
• Controlled diabetes mellitus with HbA1c < 7.5 mmol/L.
• Not on any antibiotics or steroids 3 months prior to periodontal treatment.
• Diagnosed to have either localized or generalized chronic or aggressive periodontitis (Armitage, 1999) with all 4 quadrants having at least 2 sites with probing depth ≥ 4 mm.
• Consented to follow the non-surgical periodontal treatment (scaling and root planing) with PDT throughout the period of study, i.e. approximately 6 months.

Exclusion Criteria:

• Allergic to photosensitizer or dye
• Pregnant lady and nursing mothers
• Uncontrolled diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SRP and Fotosan 630; Scaling and root planing, photodynamic therapy using Fotosan 630	Device: SRP and Fotosan 630; After isolating the test quadrants with cotton roll, toluidine blue was applied into the deep pockets (PD ≥ 4mm) at the test quadrants for 10 seconds, followed by inserting a perio tip (15 or 21 mm depending on the depth of the pocket) that connected to a LED emitting device, and light was emitted for 20 seconds. Toluidine blue in the deep pocket was removed by injecting normal saline into the pocket.; Other Names: Fotosan 630, CMS Dental, Copenhagen, Denmark
NO_INTERVENTION: Control; Scaling and root planing only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline probing depth at 3rd month and 6th month	Clinical probing depth in mm	3 months and 6 months
Changes from baseline clinical attachment level at 3rd month and 6th month	Clinical attachment level in mm	3 months and 6 months
Changes from baseline gingival recession level at 3rd month and 6th month	Gingival recession level in mm	3 months and 6 months
Changes from baseline bleeding score at 3rd month and 6th month	Bleeding score in percentage	3 months and 6 months
Changes from baseline Interleukin-1 level at 3rd month and 6th month	Interleukin-1 level in gingival crevicular fluid	3 months and 6 months
Changes from baseline Interleukin-6 level at 3rd month and 6th month	Interlekin-6 level in gingival crevicular fluid	3 months and 6 months
Changes from baseline Interleukin-8 level at 3rd month and 6th month	Interleukin-8 level in gingival crevicular fluid	3 months and 6 months
Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month	Tumour necrosis factor-alpha level in gingival crevicular fluid	3 months and 6 months
Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month	Matrix metalloproteinase-8 level in gingival crevicular fluid	3 months and 6 months

Collaborators and Investigators

• Sponsor: National University, Singapore
• Investigators: Study Director: Lum Peng Lim, Faculty of Dentistry, National University of Singapore

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ACTUAL): March 31, 2013
• Study Completion (ACTUAL): June 30, 2013

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Interleukin 1-beta; Photodynamic therapy; Interleukin-6; Interleukin-8; Tumour necrosis factor - alpha; Matrix metalloproteinase-8
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Periodontitis; Chronic Periodontitis; Periodontal Pocket; Periodontal Attachment Loss
• Other Study ID Numbers: NUSingapore

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No