Back to resultsTreatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation
Primary Purpose
Stomatitis, Aphthous
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Er,Cr:YSGG Laser
Sponsored by
About this trial
This is an interventional supportive care trial for Stomatitis, Aphthous
Eligibility Criteria
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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
test
Control
Arm Description
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.
In the placebo group, the same Er,Cr:YSGG laser without laser emission was used.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02925182
First Posted
September 28, 2016
Last Updated
October 4, 2016
Sponsor
Near East University, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT02925182
Brief Title
Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation
Official Title
Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation: A Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomatitis, Aphthous
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
In the placebo group, the same Er,Cr:YSGG laser without laser emission was used.
Intervention Type
Device
Intervention Name(s)
Er,Cr:YSGG Laser
Other Intervention Name(s)
Waterlase MD
Primary Outcome Measure Information:
Title
Reduce of Visual Analog Scale (VAS) scores
Description
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 Outcome Measure Information:
Title
The healing of recurrent aphthous (HRAS) scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Guney YILMAZ, DDS, PhD
Organizational Affiliation
Near Easat University, Faculty of Dentistry
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation
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