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

NCT03771768 | Unknown

• 1 other identifier: 3:5:1
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autoimmune; Behcet Syndrome

Keywords

Oral ulcers

Outcome Measures

Primary Outcomes (1)

• Oral ulcer activity index

  Composite index score (0-10)

  One month

Secondary Outcomes (2)

• Oral health - related quality of life

  One month

• Pain associated with oral ulcer

  One month

Study Arms (2)

Triamcinolone acetonide

ACTIVE COMPARATOR

Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.

Drug: Triamcinolone Acetonide

Diode laser

EXPERIMENTAL

Diode laser 980 nm \& 100mWatt.

Radiation: Diode laser 980nm&100 mWatt

Interventions

Diode laser 980nm&100 mWatt RADIATION

Diode laser 980 nm \&100 milli Watt.

Also known as: Low level laser, Biostimulation, Soft laser

Diode laser

Triamcinolone Acetonide DRUG

0.1 \&5gm paste 4 times/day

Also known as: Topical corticosteroid

Triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Prasad R S, Pai A. Assessment of immediate pain relief with laser treatment in recurrent aphthous stomatitis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Aug;116(2):189-93. doi: 10.1016/j.oooo.2013.02.011. Epub 2013 Apr 23.

  PMID: 23622766 BACKGROUND

• Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1.

  PMID: 24488418 BACKGROUND

• Nagieb CS, Harhash TA, Fayed HL, Ali S. Evaluation of diode laser versus topical corticosteroid in management of Behcet's disease-associated oral ulcers: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):697-704. doi: 10.1007/s00784-021-04047-8. Epub 2021 Jul 2.

  PMID: 34212234 DERIVED

MeSH Terms

Conditions

Behcet Syndrome; Oral Ulcer

Interventions

Low-Level Light Therapy; Triamcinolone Acetonide; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sherin Ali Hassan, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Clair Sobhy Nagieb, MSC

CONTACT

01222259819; Clair.nadieb@dentistry.cu.edu.eg

Zaki S.Zaki, MSC

CONTACT

01224045116; drzaki95@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Double - blinded trial: Outcome assessor (CS) and Statistician. Participants couldn't be blinded because of the difference in the nature of interventions method of application.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invistigator

Model Details: 1:1

Study Record Dates

• First Submitted: December 1, 2018
• First Posted: December 11, 2018
• Study Start: May 25, 2019
• Primary Completion: May 25, 2019
• Study Completion: May 25, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-02