Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

Study Overview
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Brief Summary
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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.

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

Official Title
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Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

Conditions
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Periodontitis, Adult, Periodontal Pocket, Periodontitis, Periodontal Attachment Loss

Intervention / Treatment
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* Device: SRP and Fotosan 630


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRP and Fotosan 630<br>Scaling and root planing, photodynamic therapy using Fotosan 630 | Device: SRP and Fotosan 630<br>* 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.<br>* Other names: Fotosan 630, CMS Dental, Copenhagen, Denmark;|
| No Intervention: Control<br>Scaling and root planing only | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8