Stomatitis, AphthousNCT02925182
Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation
A study testing Er,Cr:YSGG Laser in people with Stomatitis, Aphthous, run by Near East University, Turkey.
Trial summary
The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were included to the study. For each patient, ulceration were randomly assigned to the test or the control group. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomatitis, Aphthous
- What is being tested?
- Er,Cr:YSGG Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For inclusion every patient had to have one pairs of minor RAS duration of 3 days or less, in the buccal or labial nonkeratinized oral mucosa.
Who cannot join
- Patients with a known systemic disease that predisposed them to RAS (e.g., Behçet disease), presence of any major herpetic lesions, traumatic ulcers, ulcers caused due to topical or systemic medications, or undergoing systemic or local treatment for RAS were excluded.
About this study
Official title: Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation: A Randomized Controlled Clinical Study
The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were included to the study. For each patient, ulceration were randomly assigned to the test or the control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact mode. In the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain was evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a clinician.
- Conditions
- Stomatitis, Aphthous
- Being tested
- Er,Cr:YSGG Laser
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er,Cr:YSGG LaserDevice
Also called Waterlase MD
| Study group | Role | What they receive |
|---|---|---|
| test | Experimental | Recurrent Aphthous Stomatitis were irradiated with Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA) on hard tissue mode with a mg6 sapphire tip (600 µm diameter, 6 mm length) using non-contact mode at an energy level of 0.25W and a repetition rate of 20 kHz and pulse duration of 140 µs, 0% water and 10% air at 5 J/cm2 energy density. The treatment time was 20 s per surface by scanning the Recurrent Aphthous Stomatitis area. Receives: Device: Er,Cr:YSGG Laser |
| Control | Placebo comparator | In the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Receives: Device: Er,Cr:YSGG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce of Visual Analog Scale (VAS) scores
Patients were asked to record their pain and discomfort level for each stomatit by marking a point on a 10 cm visual analog scale (VAS).
Measured: 10 days
Secondary outcomes (1)
The healing of recurrent aphthous (HRAS) scores
The healing of RAS (HRAS) were evaluated:at the follow-up sessions by the investigator on a four-point scale (range 1-4). Grade 1 represented totally healing, grade 2 moderate healing (more than 50% of RAS was epithelialized and healed), grade 3 slightly healing (less than 50% of RAS was epithelialized and healed) and grade 4 no healing.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomatitis, AphthousStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Guney YILMAZ, Near East University, Turkey
- Investigators
- Hasan Guney YILMAZ, DDS, PhD, Study director, Near Easat University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925182
- Sponsor's protocol ID
- CE018-2015
- Status last verified
- Oct 2016
- First submitted
- 28 Sep 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02925182
- Acronym / sponsor ID
- CE018-2015
- Conditions
- Stomatitis, Aphthous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Oct 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.
The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were included to the study. For each patient, ulceration were randomly assigned to the test or the control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact mode. In the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain was evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a clinician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test | Experimental | Device: Er,Cr:YSGG LaserRecurrent Aphthous Stomatitis were irradiated with Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA) on hard tissue mode with a mg6 sapphire tip (600 µm diameter, 6 mm length) using non-contact mode at an energy level of 0.25W and a repetition rate of 20 kHz and pulse duration of 140 µs, 0% water and 10% air at 5 J/cm2 energy density. The treatment time was 20 s per surface by scanning the Recurrent Aphthous Stomatitis area. |
| Control | Placebo comparator | Device: Er,Cr:YSGG LaserIn the placebo group, the same Er,Cr:YSGG laser without laser emission was used. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- For inclusion every patient had to have one pairs of minor RAS duration of 3 days or less, in the buccal or labial nonkeratinized oral mucosa.
Key exclusion criteria (1 listed)
- Patients with a known systemic disease that predisposed them to RAS (e.g., Behçet disease), presence of any major herpetic lesions, traumatic ulcers, ulcers caused due to topical or systemic medications, or undergoing systemic or local treatment for RAS were excluded.
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 |
|---|---|---|
| Er,Cr:YSGG LaserAlso: Waterlase MD | Device | Control, test |
Primary outcome
Reduce of Visual Analog Scale (VAS) scores
Time frame: 10 days
Patients were asked to record their pain and discomfort level for each stomatit by marking a point on a 10 cm visual analog scale (VAS).
1 secondary outcome
The healing of recurrent aphthous (HRAS) scores
Time frame: 10 days
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 Oct 2016.
- 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.
Hasan Guney YILMAZ, DDS, PhD study director
Near Easat University, Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Er,Cr:YSGG Laser in people with Stomatitis, Aphthous, run by Near East University, Turkey.
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 1 inclusion and 1 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 Oct 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. Some participants in this study may receive a placebo. 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?
Reduce of Visual Analog Scale (VAS) scores (time frame: 10 days). 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 Oct 2016.