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