Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
Primary Purpose
Periodontitis, Adult, Periodontal Pocket, Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SRP and Fotosan 630
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis, Adult focused on measuring Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SRP and Fotosan 630
Control
Arm Description
Scaling and root planing, photodynamic therapy using Fotosan 630
Scaling and root planing only
Outcomes
Primary Outcome Measures
Changes from baseline probing depth at 3rd month and 6th month
Clinical probing depth in mm
Changes from baseline clinical attachment level at 3rd month and 6th month
Clinical attachment level in mm
Changes from baseline gingival recession level at 3rd month and 6th month
Gingival recession level in mm
Changes from baseline bleeding score at 3rd month and 6th month
Bleeding score in percentage
Changes from baseline Interleukin-1 level at 3rd month and 6th month
Interleukin-1 level in gingival crevicular fluid
Changes from baseline Interleukin-6 level at 3rd month and 6th month
Interlekin-6 level in gingival crevicular fluid
Changes from baseline Interleukin-8 level at 3rd month and 6th month
Interleukin-8 level in gingival crevicular fluid
Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month
Tumour necrosis factor-alpha level in gingival crevicular fluid
Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month
Matrix metalloproteinase-8 level in gingival crevicular fluid
Secondary Outcome Measures
Full Information
NCT ID
NCT03453476
First Posted
January 23, 2018
Last Updated
February 26, 2018
Sponsor
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03453476
Brief Title
Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
Official Title
Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
March 31, 2013 (Actual)
Study Completion Date
June 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult, Periodontal Pocket, Periodontitis, Periodontal Attachment Loss
Keywords
Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth design
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRP and Fotosan 630
Arm Type
Experimental
Arm Description
Scaling and root planing, photodynamic therapy using Fotosan 630
Arm Title
Control
Arm Type
No Intervention
Arm Description
Scaling and root planing only
Intervention Type
Device
Intervention Name(s)
SRP and Fotosan 630
Other Intervention Name(s)
Fotosan 630, CMS Dental, Copenhagen, Denmark
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline probing depth at 3rd month and 6th month
Description
Clinical probing depth in mm
Time Frame
3 months and 6 months
Title
Changes from baseline clinical attachment level at 3rd month and 6th month
Description
Clinical attachment level in mm
Time Frame
3 months and 6 months
Title
Changes from baseline gingival recession level at 3rd month and 6th month
Description
Gingival recession level in mm
Time Frame
3 months and 6 months
Title
Changes from baseline bleeding score at 3rd month and 6th month
Description
Bleeding score in percentage
Time Frame
3 months and 6 months
Title
Changes from baseline Interleukin-1 level at 3rd month and 6th month
Description
Interleukin-1 level in gingival crevicular fluid
Time Frame
3 months and 6 months
Title
Changes from baseline Interleukin-6 level at 3rd month and 6th month
Description
Interlekin-6 level in gingival crevicular fluid
Time Frame
3 months and 6 months
Title
Changes from baseline Interleukin-8 level at 3rd month and 6th month
Description
Interleukin-8 level in gingival crevicular fluid
Time Frame
3 months and 6 months
Title
Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month
Description
Tumour necrosis factor-alpha level in gingival crevicular fluid
Time Frame
3 months and 6 months
Title
Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month
Description
Matrix metalloproteinase-8 level in gingival crevicular fluid
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lum Peng Lim
Organizational Affiliation
Faculty of Dentistry, National University of Singapore
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
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