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

Primary Purpose

Autoimmune, Behcet Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diode laser 980nm&100 mWatt
Triamcinolone Acetonide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune focused on measuring Oral ulcers

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Triamcinolone acetonide

    Diode laser

    Arm Description

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

    Diode laser 980 nm & 100mWatt.

    Outcomes

    Primary Outcome Measures

    Oral ulcer activity index
    Composite index score (0-10)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 1, 2018
    Last Updated
    April 8, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03771768
    Brief Title
    Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease
    Acronym
    BD
    Official Title
    Active Control,Randomized,Double- Blinded Clinical Trial of BD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 25, 2019 (Anticipated)
    Primary Completion Date
    May 25, 2019 (Anticipated)
    Study Completion Date
    May 25, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autoimmune, Behcet Syndrome
    Keywords
    Oral ulcers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    1:1
    Masking
    Care ProviderInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Triamcinolone acetonide
    Arm Type
    Active Comparator
    Arm Description
    Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.
    Arm Title
    Diode laser
    Arm Type
    Experimental
    Arm Description
    Diode laser 980 nm & 100mWatt.
    Intervention Type
    Radiation
    Intervention Name(s)
    Diode laser 980nm&100 mWatt
    Other Intervention Name(s)
    Low level laser, Biostimulation, Soft laser
    Intervention Description
    Diode laser 980 nm &100 milli Watt.
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone Acetonide
    Other Intervention Name(s)
    Topical corticosteroid
    Intervention Description
    0.1 &5gm paste 4 times/day
    Primary Outcome Measure Information:
    Title
    Oral ulcer activity index
    Description
    Composite index score (0-10)
    Time Frame
    One month
    Secondary Outcome Measure Information:
    Title
    Oral health - related quality of life
    Description
    Oral health impact profile - 14 (OHIP- 14)
    Time Frame
    One month
    Title
    Pain associated with oral ulcer
    Description
    Visual analogue scale (0-10)
    Time Frame
    One month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clair Sobhy Nagieb, MSC
    Phone
    01222259819
    Ext
    Cairo U
    Email
    Clair.nadieb@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zaki S.Zaki, MSC
    Phone
    01224045116
    Email
    drzaki95@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherin Ali Hassan, MD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23622766
    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.
    Results Reference
    background
    PubMed Identifier
    24488418
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34212234
    Citation
    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.
    Results Reference
    derived

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

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