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

NCT ID: NCT03771768

Last Updated: 2019-04-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-25

Study Completion Date

2019-05-25

Brief Summary

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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

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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.

Conditions

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Autoimmune Behcet Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators
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.

Study Groups

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Triamcinolone acetonide

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

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

0.1 \&5gm paste 4 times/day

Diode laser

Diode laser 980 nm \& 100mWatt.

Group Type EXPERIMENTAL

Diode laser 980nm&100 mWatt

Intervention Type RADIATION

Diode laser 980 nm \&100 milli Watt.

Interventions

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Diode laser 980nm&100 mWatt

Diode laser 980 nm \&100 milli Watt.

Intervention Type RADIATION

Triamcinolone Acetonide

0.1 \&5gm paste 4 times/day

Intervention Type DRUG

Other Intervention Names

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Low level laser Biostimulation Soft laser Topical corticosteroid

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Clair Sobhy Nagieb Botros

Principal invistigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherin Ali Hassan, MD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Clair Sobhy Nagieb, MSC

Role: CONTACT

01222259819 ext. Cairo U

Zaki S.Zaki, MSC

Role: CONTACT

01224045116

References

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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.

Reference Type BACKGROUND
PMID: 23622766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24488418 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34212234 (View on PubMed)

Other Identifiers

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3:5:1

Identifier Type: -

Identifier Source: org_study_id

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