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

NCT02925182 | Completed

• 1 other identifier: CE018-2015
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stomatitis, Aphthous

Outcome Measures

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).

  10 days

Secondary Outcomes (1)

• The healing of recurrent aphthous (HRAS) scores

  10 days

Study Arms (2)

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.

Device: Er,Cr:YSGG Laser

Control

PLACEBO COMPARATOR

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

Device: Er,Cr:YSGG Laser

Interventions

Er,Cr:YSGG Laser DEVICE

Also known as: Waterlase MD

Control; test

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Near East University, Turkey: lead

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hasan Guney YILMAZ, DDS, PhD

  Near Easat University, Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 5, 2016
• Study Start: January 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: March 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share