Periodontitis, AdultNCT03453476
Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
A study testing SRP and Fotosan 630 in people with Periodontitis, Adult and Periodontal Pocket, run by National University of Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult, Periodontal Pocket, Periodontitis
- What is being tested?
- SRP and Fotosan 630
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Allergic to photosensitizer or dye
- Pregnant lady and nursing mothers
- Uncontrolled diabetes
About this study
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.
Read the detailed description
Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.
- Being tested
- SRP and Fotosan 630
- Keywords
- Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8
- Medical subject headings
- Chronic Periodontitis, Periodontal Pocket, Periodontitis, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP and Fotosan 630Device
Also called Fotosan 630, CMS Dental, Copenhagen, Denmark
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.
| Study group | Role | What they receive |
|---|---|---|
| SRP and Fotosan 630 | Experimental | Scaling and root planing, photodynamic therapy using Fotosan 630 Receives: Device: SRP and Fotosan 630 |
| Control | No intervention | Scaling and root planing only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline probing depth at 3rd month and 6th month
Clinical probing depth in mm
Measured: 3 months and 6 months
Changes from baseline clinical attachment level at 3rd month and 6th month
Clinical attachment level in mm
Measured: 3 months and 6 months
Changes from baseline gingival recession level at 3rd month and 6th month
Gingival recession level in mm
Measured: 3 months and 6 months
Changes from baseline bleeding score at 3rd month and 6th month
Bleeding score in percentage
Measured: 3 months and 6 months
Changes from baseline Interleukin-1 level at 3rd month and 6th month
Interleukin-1 level in gingival crevicular fluid
Measured: 3 months and 6 months
Changes from baseline Interleukin-6 level at 3rd month and 6th month
Interlekin-6 level in gingival crevicular fluid
Measured: 3 months and 6 months
Changes from baseline Interleukin-8 level at 3rd month and 6th month
Interleukin-8 level in gingival crevicular fluid
Measured: 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
Measured: 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
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Jan 2012
- Primary completion31 Mar 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Foo Lean Heong, National University of Singapore
- Investigators
- Lum Peng Lim, Study director, Faculty of Dentistry, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453476
- Sponsor's protocol ID
- NUSingapore
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03453476
- Acronym / sponsor ID
- NUSingapore
- Keywords
- Photodynamic therapy, Interleukin 1-beta, Tumour necrosis factor - alpha, Interleukin-6, Interleukin-8, Matrix metalloproteinase-8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Mar 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| SRP and Fotosan 630 | Experimental | Device: SRP and Fotosan 630Scaling and root planing, photodynamic therapy using Fotosan 630 |
| Control | No intervention | –Scaling and root planing only |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Allergic to photosensitizer or dye
- Pregnant lady and nursing mothers
- Uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRP and Fotosan 630Also: Fotosan 630, CMS Dental, Copenhagen, DenmarkAfter 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. | Device | SRP and Fotosan 630 |
Primary outcome
Changes from baseline probing depth at 3rd month and 6th month
Time frame: 3 months and 6 months
Clinical probing depth in mm
Changes from baseline clinical attachment level at 3rd month and 6th month
Time frame: 3 months and 6 months
Clinical attachment level in mm
Changes from baseline gingival recession level at 3rd month and 6th month
Time frame: 3 months and 6 months
Gingival recession level in mm
Changes from baseline bleeding score at 3rd month and 6th month
Time frame: 3 months and 6 months
Bleeding score in percentage
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lum Peng Lim study director
Faculty of Dentistry, National University of Singapore
Questions about this trial
What is this clinical trial studying?
A study testing SRP and Fotosan 630 in people with Periodontitis, Adult and Periodontal Pocket, run by National University of Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline probing depth at 3rd month and 6th month (time frame: 3 months and 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.