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

Behcet Syndrome Clinical Trial

— BD  

Official title:

Active Control,Randomized,Double- Blinded Clinical Trial of BD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03771768
• Other study ID #: 3:5:1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2019
• Est. completion date: May 25, 2019

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: Clair Sobhy Nagieb, MSC
• Phone: 01222259819
• Email: Clair.nadieb[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune
• Behcet Syndrome
• Oral Ulcer

Intervention

Radiation:
• Diode laser 980nm&100 mWatt
Diode laser 980 nm &100 milli Watt.

Drug:
• Triamcinolone Acetonide
0.1 &5gm paste 4 times/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral ulcer activity index	Composite index score (0-10)	One month
Secondary	Oral health - related quality of life	Oral health impact profile - 14 (OHIP- 14)	One month
Secondary	Pain associated with oral ulcer	Visual analogue scale (0-10)	One month