<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771768</url>
  </required_header>
  <id_info>
    <org_study_id>3:5:1</org_study_id>
    <nct_id>NCT03771768</nct_id>
  </id_info>
  <brief_title>Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease</brief_title>
  <acronym>BD</acronym>
  <official_title>Active Control,Randomized,Double- Blinded Clinical Trial of BD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laser therapy is increasingly showing promising results in dental field including oral&#xD;
      ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on&#xD;
      oral ulcers of patients diagnosed with Behcet's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The enrolled patients will be divided randomly into two groups.one group will receive Diode&#xD;
      Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and&#xD;
      other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide&#xD;
      0.1% 5 gram adhesive paste - Dermaphor) four times daily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 25, 2019</start_date>
  <completion_date type="Anticipated">May 25, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 25, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>1:1</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <masking_description>Double - blinded trial:&#xD;
Outcome assessor (CS) and Statistician. Participants couldn't be blinded because of the difference in the nature of interventions method of application.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oral ulcer activity index</measure>
    <time_frame>One month</time_frame>
    <description>Composite index score (0-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral health - related quality of life</measure>
    <time_frame>One month</time_frame>
    <description>Oral health impact profile - 14 (OHIP- 14)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain associated with oral ulcer</measure>
    <time_frame>One month</time_frame>
    <description>Visual analogue scale (0-10)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Autoimmune</condition>
  <condition>Behcet Syndrome</condition>
  <arm_group>
    <arm_group_label>Triamcinolone acetonide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diode laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diode laser 980 nm &amp; 100mWatt.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Diode laser 980nm&amp;100 mWatt</intervention_name>
    <description>Diode laser 980 nm &amp;100 milli Watt.</description>
    <arm_group_label>Diode laser</arm_group_label>
    <other_name>Low level laser</other_name>
    <other_name>Biostimulation</other_name>
    <other_name>Soft laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide</intervention_name>
    <description>0.1 &amp;5gm paste 4 times/day</description>
    <arm_group_label>Triamcinolone acetonide</arm_group_label>
    <other_name>Topical corticosteroid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with Behcet's Disease according to International Criteria for BD.&#xD;
&#xD;
          -  patients with active oral ulcers.&#xD;
&#xD;
          -  patients free from any visible oral lesions other than the oral ulcers of BD.&#xD;
&#xD;
          -  patients who agreed to take the supplied interventions.&#xD;
&#xD;
          -  patients who will agree to participate in the study.&#xD;
&#xD;
          -  patients who will accept to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients not physically able to participate in survey or clinical oral examination.&#xD;
&#xD;
          -  patients with organ or life-threatening disease.&#xD;
&#xD;
          -  patients with history of a severe or chronic medical condition including tuberculosis,&#xD;
             hepatitis and human immunodeficiency virus.&#xD;
&#xD;
          -  patients under immunosuppressive drugs.&#xD;
&#xD;
          -  patients with organ transplantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherin Ali Hassan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clair Sobhy Nagieb, MSC</last_name>
    <phone>01222259819</phone>
    <phone_ext>Cairo U</phone_ext>
    <email>Clair.nadieb@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zaki S.Zaki, MSC</last_name>
    <phone>01224045116</phone>
    <email>drzaki95@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <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.</citation>
    <PMID>23622766</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24488418</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Clair Sobhy Nagieb Botros</investigator_full_name>
    <investigator_title>Principal invistigator</investigator_title>
  </responsible_party>
  <keyword>Oral ulcers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Oral Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771768
org study id: 3:5:1
nct id: NCT03771768
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1
primary purpose: Treatment
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.
measure: Oral ulcer activity index
time frame: One month
description: Composite index score (0-10)
measure: Oral health - related quality of life
time frame: One month
description: Oral health impact profile - 14 (OHIP- 14)
measure: Pain associated with oral ulcer
time frame: One month
description: Visual analogue scale (0-10)
arm group label: Triamcinolone acetonide
arm group type: Active Comparator
description: Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.
arm group label: Diode laser
arm group type: Experimental
description: Diode laser 980 nm & 100mWatt.
intervention type: Radiation
intervention name: Diode laser 980nm&100 mWatt
description: Diode laser 980 nm &100 milli Watt.
arm group label: Diode laser
other name: Low level laser
other name: Biostimulation
other name: Soft laser
intervention type: Drug
intervention name: Triamcinolone Acetonide
description: 0.1 &5gm paste 4 times/day
arm group label: Triamcinolone acetonide
other name: Topical corticosteroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sherin Ali Hassan, MD
role: Study Director
affiliation: Cairo University
last name: Clair Sobhy Nagieb, MSC
phone: 01222259819
phone ext: Cairo U
email: Clair.nadieb@dentistry.cu.edu.eg
last name: Zaki S.Zaki, MSC
phone: 01224045116
email: drzaki95@yahoo.com
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.
PMID: 23622766
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.
PMID: 24488418
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Clair Sobhy Nagieb Botros
investigator title: Principal invistigator
mesh term: Behcet Syndrome
mesh term: Oral Ulcer
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate
sharing ipd: Undecided