ClinicalTrials.gg
CompletedNCT03453476Updated Mar 5, 2018

Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients

An interventional study of SRP and Fotosan 630 in Periodontitis, Adult, Periodontal Pocket and Periodontitis, sponsored by National University of Singapore. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by National University of Singapore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years after the study started (first participant enrolled Jan 2012, registered Jan 2018).

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Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • 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
03

In context

Chronic Periodontitis

377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.

This study's enrollment of 51 is above the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.

Browse Chronic Periodontitis studies →

Lead sponsor

National University of Singapore is the lead sponsor of 212 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 \< 7.5 mmol/L.
  • Not on any antibiotics or 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

Exclusion Criteria:

  • Allergic to photosensitizer or dye
  • Pregnant lady and nursing mothers
  • Uncontrolled diabetes
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    SRP and Fotosan 630

    Scaling and root planing, photodynamic therapy using Fotosan 630

    Device: SRP and Fotosan 630

  • No intervention
    Control

    Scaling and root planing only

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.

    Also known as: Fotosan 630, CMS Dental, Copenhagen, Denmark

06

What researchers measure

Primary outcomes

  1. Changes from baseline probing depth at 3rd month and 6th month

    Clinical probing depth in mm

    Time frame: 3 months and 6 months

  2. Changes from baseline clinical attachment level at 3rd month and 6th month

    Clinical attachment level in mm

    Time frame: 3 months and 6 months

  3. Changes from baseline gingival recession level at 3rd month and 6th month

    Gingival recession level in mm

    Time frame: 3 months and 6 months

  4. Changes from baseline bleeding score at 3rd month and 6th month

    Bleeding score in percentage

    Time frame: 3 months and 6 months

  5. Changes from baseline Interleukin-1 level at 3rd month and 6th month

    Interleukin-1 level in gingival crevicular fluid

    Time frame: 3 months and 6 months

  6. Changes from baseline Interleukin-6 level at 3rd month and 6th month

    Interlekin-6 level in gingival crevicular fluid

    Time frame: 3 months and 6 months

  7. Changes from baseline Interleukin-8 level at 3rd month and 6th month

    Interleukin-8 level in gingival crevicular fluid

    Time frame: 3 months and 6 months

  8. Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month

    Tumour necrosis factor-alpha level in gingival crevicular fluid

    Time frame: 3 months and 6 months

  9. Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month

    Matrix metalloproteinase-8 level in gingival crevicular fluid

    Time frame: 3 months and 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2012 to primary completion in Mar 2013, 14 months.

Of 88 non-industry interventional studies with no phase under Chronic Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 24. This study's 14 months is close to that.

Counting every sponsor, half of 89 studies reached it within 15 months; a quarter within 10 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Mar 5, 2018
StartActual
Jan 1, 2012
Primary completionActual
Mar 31, 2013
CompletionActual
Jun 30, 2013
Last update
Mar 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03453476
Responsible party
Foo Lean Heong (Periodontic Resident, Faculty of Dentistry, National University of Singapore) — Principal investigator
First posted
Mar 5, 2018
Start date
Jan 1, 2012
Primary completion
Mar 31, 2013
Completion
Jun 30, 2013
Last update
Mar 5, 2018

Study contacts

Lum Peng Lim
study director · Faculty of Dentistry, National University of Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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