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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03771768
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Clair Sobhy Nagieb Botros, 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.

Condition or disease Intervention/treatment Phase
Autoimmune Behcet Syndrome Radiation: Diode laser 980nm&100 mWatt Drug: Triamcinolone Acetonide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1
Masking: Double (Care Provider, Investigator)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Active Control,Randomized,Double- Blinded Clinical Trial of BD
Estimated Study Start Date : May 25, 2019
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : May 25, 2019


Arm Intervention/treatment
Active Comparator: Triamcinolone acetonide
Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.
Drug: Triamcinolone Acetonide
0.1 &5gm paste 4 times/day
Other Name: Topical corticosteroid

Experimental: Diode laser
Diode laser 980 nm & 100mWatt.
Radiation: Diode laser 980nm&100 mWatt
Diode laser 980 nm &100 milli Watt.
Other Names:
  • Low level laser
  • Biostimulation
  • Soft laser




Primary Outcome Measures :
  1. Oral ulcer activity index [ Time Frame: One month ]
    Composite index score (0-10)


Secondary Outcome Measures :
  1. Oral health - related quality of life [ Time Frame: One month ]
    Oral health impact profile - 14 (OHIP- 14)

  2. Pain associated with oral ulcer [ Time Frame: One month ]
    Visual analogue scale (0-10)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771768


Contacts
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Contact: Clair Sobhy Nagieb, MSC 01222259819 ext Cairo U Clair.nadieb@dentistry.cu.edu.eg
Contact: Zaki S.Zaki, MSC 01224045116 drzaki95@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Sherin Ali Hassan, MD Cairo University

Publications:
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Responsible Party: Clair Sobhy Nagieb Botros, Principal invistigator, Cairo University
ClinicalTrials.gov Identifier: NCT03771768    
Other Study ID Numbers: 3:5:1
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clair Sobhy Nagieb Botros, Cairo University:
Oral ulcers
Additional relevant MeSH terms:
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Behcet Syndrome
Oral Ulcer
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action