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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Stomatitis, Aphthous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Er,Cr:YSGG Laser

Intervention Type DEVICE

Control

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

Group Type PLACEBO_COMPARATOR

Er,Cr:YSGG Laser

Intervention Type DEVICE

Interventions

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Er,Cr:YSGG Laser

Intervention Type DEVICE

Other Intervention Names

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Waterlase MD

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes