Periodontal DiseasesPhase 4NCT02666573
Photodynamic Therapy During Supportive Periodontal Therapy
A Phase 4 study testing Fotosan 630, CMS Dental, Copenhagen, Denmark and Scaling and root planing in people with Periodontal Diseases and Chronic Periodontitis, run by National University of Singapore.
Trial summary
27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on probing (BOP) of all sites were examined. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Chronic Periodontitis, Periodontal Attachment Loss
- What is being tested?
- Fotosan 630, CMS Dental, Copenhagen, Denmark and Scaling and root planing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Good general health with no systemic diseases causing manifestation of periodontal diseases
- Age ≥ 21 years
- History of chronic periodontitis
- At least two residual PPD ≥ 5 mm with or without bleeding on probing
- Compliant with recalls, i.e. last SPT visit at most 6 months before start of trial
- Able to give written informed consent
Who cannot join
- Pregnant or lactating females
- Local or systemic antibiotics intake in the past 3 months
- Systemic conditions which could affect progression of periodontitis
- Long term use of NSAIDs or immunosuppressive medications
- Participation in other clinical trials
About this study
Official title: Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy
27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received subgingival instrumentation and rubber cup polishing with pumice. In addition test sites received a single application of PDT using Fotosan® and photosensitizer consisting of toludine blue O solution. The subjects were recalled three and six months later and re-examined. Site level analysis was performed.
- Being tested
- Fotosan 630, CMS Dental, Copenhagen, Denmark, Scaling and root planing
- Keywords
- drug therapy, Photosensitizing Agents, therapeutic use
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fotosan 630, CMS Dental, Copenhagen, DenmarkDevice
The PDT system consists of a hand-held rechargeable light-emitting diode (LED) light source (Fotosan® 630 device, CMS Dental, Copenhagen, Denmark) and 0.1 mg/mL toluidine blue photosensitiser. The LED light source has a wavelength between 620 to 640 nm and peak of 630 nm and a power density between 2000 to 4000 mW/cm2.
Scaling and root planingOther
Scaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy protocol | Experimental | In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions. Receives: Device: Fotosan 630, CMS Dental, Copenhagen, Denmark |
| SRP | Other | Scaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste. Receives: Other: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in percentage change in probing pocket depth
Measured: 6 months
Secondary outcomes (4)
Bleeding on probing
Measured: 6 months
Clinical attachment level
Measured: 6 months
Recession
Measured: 6 months
Cytokines level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJun 2013
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goh Xian Jun Edwin, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666573
- Sponsor's protocol ID
- R-221-000-044-597
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy
- ClinicalTrials.gov ID
- NCT02666573
- Acronym / sponsor ID
- R-221-000-044-597
- Keywords
- drug therapy, Photosensitizing Agents, therapeutic use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 28 Jan 2016 (estimated)
- 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.
27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received subgingival instrumentation and rubber cup polishing with pumice. In addition test sites received a single application of PDT using Fotosan® and photosensitizer consisting of toludine blue O solution. The subjects were recalled three and six months later and re-examined. Site level analysis was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy protocol | Experimental | Device: Fotosan 630, CMS Dental, Copenhagen, DenmarkIn addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions. |
| SRP | Other | Other: Scaling and root planingScaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Good general health with no systemic diseases causing manifestation of periodontal diseases
- Age ≥ 21 years
- History of chronic periodontitis
- At least two residual PPD ≥ 5 mm with or without bleeding on probing
- Compliant with recalls, i.e. last SPT visit at most 6 months before start of trial
Key exclusion criteria (5 listed)
- Pregnant or lactating females
- Local or systemic antibiotics intake in the past 3 months
- Systemic conditions which could affect progression of periodontitis
- Long term use of NSAIDs or immunosuppressive medications
- Participation in other clinical trials
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 |
|---|---|---|
| Fotosan 630, CMS Dental, Copenhagen, DenmarkThe PDT system consists of a hand-held rechargeable light-emitting diode (LED) light source (Fotosan® 630 device, CMS Dental, Copenhagen, Denmark) and 0.1 mg/mL toluidine blue photosensitiser. The LED light source has a wavelength between 620 to 640 nm and peak of 630 nm and a power density between 2000 to 4000 mW/cm2. | Device | Photodynamic therapy protocol |
| Scaling and root planingScaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste. | Other | SRP |
Primary outcome
Difference in percentage change in probing pocket depth
Time frame: 6 months
4 secondary outcomes
Bleeding on probing
Time frame: 6 months
Clinical attachment level
Time frame: 6 months
Recession
Time frame: 6 months
Cytokines level
Time frame: 6 months
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 28 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fotosan 630, CMS Dental, Copenhagen, Denmark and Scaling and root planing in people with Periodontal Diseases and Chronic Periodontitis, 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 5 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 28 Jan 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in percentage change in probing pocket depth (time frame: 6 months). 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 28 Jan 2016.