Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

Periodontitis Clinical Trial

Official title:

Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453476
• Other study ID #: NUSingapore
• Status: Completed
• Phase: N/A
• First received: January 23, 2018
• Last updated: February 26, 2018
• Start date: January 1, 2012
• Est. completion date: June 30, 2013

Study information

• Verified date: February 2018
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 30, 2013
• Est. primary completion date: March 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontal Attachment Loss
• Periodontal Pocket
• Periodontitis
• Periodontitis, Adult

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline probing depth at 3rd month and 6th month	Clinical probing depth in mm	3 months and 6 months
Primary	Changes from baseline clinical attachment level at 3rd month and 6th month	Clinical attachment level in mm	3 months and 6 months
Primary	Changes from baseline gingival recession level at 3rd month and 6th month	Gingival recession level in mm	3 months and 6 months
Primary	Changes from baseline bleeding score at 3rd month and 6th month	Bleeding score in percentage	3 months and 6 months
Primary	Changes from baseline Interleukin-1 level at 3rd month and 6th month	Interleukin-1 level in gingival crevicular fluid	3 months and 6 months
Primary	Changes from baseline Interleukin-6 level at 3rd month and 6th month	Interlekin-6 level in gingival crevicular fluid	3 months and 6 months
Primary	Changes from baseline Interleukin-8 level at 3rd month and 6th month	Interleukin-8 level in gingival crevicular fluid	3 months and 6 months
Primary	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
Primary	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