- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03453476
Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
February 26, 2018 updated by: Foo Lean Heong, National University, Singapore
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SRP and Fotosan 630
Scaling and root planing, photodynamic therapy using 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:
|
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
Time Frame: 3 months and 6 months
|
Clinical probing depth in mm
|
3 months and 6 months
|
Changes from baseline clinical attachment level at 3rd month and 6th month
Time Frame: 3 months and 6 months
|
Clinical attachment level in mm
|
3 months and 6 months
|
Changes from baseline gingival recession level at 3rd month and 6th month
Time Frame: 3 months and 6 months
|
Gingival recession level in mm
|
3 months and 6 months
|
Changes from baseline bleeding score at 3rd month and 6th month
Time Frame: 3 months and 6 months
|
Bleeding score in percentage
|
3 months and 6 months
|
Changes from baseline Interleukin-1 level at 3rd month and 6th month
Time Frame: 3 months and 6 months
|
Interleukin-1 level in gingival crevicular fluid
|
3 months and 6 months
|
Changes from baseline Interleukin-6 level at 3rd month and 6th month
Time Frame: 3 months and 6 months
|
Interlekin-6 level in gingival crevicular fluid
|
3 months and 6 months
|
Changes from baseline Interleukin-8 level at 3rd month and 6th month
Time Frame: 3 months and 6 months
|
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
Time Frame: 3 months and 6 months
|
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
Time Frame: 3 months and 6 months
|
Matrix metalloproteinase-8 level in gingival crevicular fluid
|
3 months and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lum Peng Lim, Faculty of Dentistry, National University of Singapore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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