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

Overview

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.

Full Title of Study: “Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation: A Randomized Controlled Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2015

Interventions

  • Device: Er,Cr:YSGG Laser

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • The healing of recurrent aphthous (HRAS) scores
    • Time Frame: 10 days
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Near East University, Turkey
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hasan Guney YILMAZ, Assoc Prof Dr – Near East University, Turkey
  • Overall Official(s)
    • Hasan Guney YILMAZ, DDS, PhD, Study Director, Near Easat University, Faculty of Dentistry

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.