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CompletedNCT02925182Updated Oct 5, 2016

Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation

An interventional study of Er,Cr:YSGG Laser in Stomatitis, Aphthous, sponsored by Near East University, Turkey. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-05.

Sponsored by Near East University, Turkey · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Stomatitis, Aphthous

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03

In context

Stomatitis, Aphthous

63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.

This study's enrollment of 40 is close to the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.

Browse Stomatitis, Aphthous studies →

Lead sponsor

Near East University, Turkey is the lead sponsor of 44 studies on the registry; 4 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 60 Years
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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    test

    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.

    Device: Er,Cr:YSGG Laser

  • Placebo comparator
    Control

    In the placebo group, the same Er,Cr:YSGG laser without laser emission was used.

    Device: Er,Cr:YSGG Laser

Interventions

  • DeviceEr,Cr:YSGG Laser

    Also known as: Waterlase MD

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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.

    Time frame: 10 days

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02925182
Lead sponsor
Near East University, Turkey
Responsible party
Hasan Guney YILMAZ (Assoc Prof Dr, Near East University, Turkey) — Principal investigator
First posted
Oct 5, 2016
Start date
Jan 2015
Primary completion
May 2015
Completion
Mar 2016
Last update
Oct 5, 2016

Study contacts

Hasan Guney YILMAZ, DDS, PhD
study director · Near Easat University, Faculty of Dentistry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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