Periodontal Attachment Loss, Periodontal Pocket, Periodontitis, Periodontitis, Adult
Conditions
Keywords
Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8
Brief 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.
Detailed description
Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.
Interventions
DEVICESRP 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.
Sponsors
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Allocation of test and control quadrants were done randomly by asking each study participant to choose either numbers 1 or 2. Number 1 defined quadrants 1 and 3 as the test quadrants while number 2 referred to quadrants 2 and 4 as the test quadrants. The remaining quadrants served as the control quadrants.
Intervention model description
Split-mouth design
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline probing depth at 3rd month and 6th month | 3 months and 6 months | Clinical probing depth in mm |
| Changes from baseline clinical attachment level at 3rd month and 6th month | 3 months and 6 months | Clinical attachment level in mm |
| Changes from baseline gingival recession level at 3rd month and 6th month | 3 months and 6 months | Gingival recession level in mm |
| Changes from baseline bleeding score at 3rd month and 6th month | 3 months and 6 months | Bleeding score in percentage |
| Changes from baseline Interleukin-1 level at 3rd month and 6th month | 3 months and 6 months | Interleukin-1 level in gingival crevicular fluid |
| Changes from baseline Interleukin-6 level at 3rd month and 6th month | 3 months and 6 months | Interlekin-6 level in gingival crevicular fluid |
| Changes from baseline Interleukin-8 level at 3rd month and 6th month | 3 months and 6 months | Interleukin-8 level in gingival crevicular fluid |
| Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month | 3 months and 6 months | Tumour necrosis factor-alpha level in gingival crevicular fluid |
| Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month | 3 months and 6 months | Matrix metalloproteinase-8 level in gingival crevicular fluid |
Outcome results
None listed