Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease

Not Applicable

• Conditions: Behcet Syndrome; Autoimmune
• Interventions: Radiation: Diode laser 980nm&100 mWatt; Drug: Triamcinolone Acetonide

• Registration Number: NCT03771768
• Lead Sponsor: Cairo University

Brief Summary

Laser therapy is increasingly showing promising results in dental field including oral ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on oral ulcers of patients diagnosed with Behcet's disease.

Detailed Description

The enrolled patients will be divided randomly into two groups.one group will receive Diode Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermaphor) four times daily.

Study Timeline

• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-09
• Study Start: 2019-05-25
• Primary Completion: 2019-05-25
• Study Completion: 2019-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• patients diagnosed with Behcet's Disease according to International Criteria for BD.
• patients with active oral ulcers.
• patients free from any visible oral lesions other than the oral ulcers of BD.
• patients who agreed to take the supplied interventions.
• patients who will agree to participate in the study.
• patients who will accept to sign the informed consent.

Exclusion Criteria

• patients not physically able to participate in survey or clinical oral examination.
• patients with organ or life-threatening disease.
• patients with history of a severe or chronic medical condition including tuberculosis, hepatitis and human immunodeficiency virus.
• patients under immunosuppressive drugs.
• patients with organ transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diode laser	Diode laser 980nm&100 mWatt	Diode laser 980 nm \& 100mWatt.
Triamcinolone acetonide	Triamcinolone Acetonide	Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.

Primary Outcome Measures

Name	Time	Method
Oral ulcer activity index	One month	Composite index score (0-10)

Secondary Outcome Measures

Name	Time	Method
Pain associated with oral ulcer	One month	Visual analogue scale (0-10)
Oral health - related quality of life	One month	Oral health impact profile - 14 (OHIP- 14)