search
Back to results

Treatment 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
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stomatitis, Aphthous

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 28, 2016
    Last Updated
    October 4, 2016
    Sponsor
    Near East University, Turkey
    search

    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

    We'll reach out to this number within 24 hrs