|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03771768 |
|
Date of registration:
|
01/12/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease
BD |
|
Scientific title:
|
Active Control,Randomized,Double- Blinded Clinical Trial of BD |
|
Date of first enrolment:
|
May 25, 2019 |
|
Target sample size:
|
38 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03771768 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Investigator).
|
|
Phase:
|
N/A
|
|
|
Contacts
|
|
Name:
|
Clair Sobhy Nagieb, MSC |
|
Address:
|
|
|
Telephone:
|
01222259819 |
|
Email:
|
Clair.nadieb@dentistry.cu.edu.eg |
|
Affiliation:
|
|
|
|
Name:
|
Sherin Ali Hassan, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cairo University |
| |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Behcet Syndrome
|
|
Autoimmune
|
|
Intervention(s)
|
|
Drug: Triamcinolone Acetonide
|
|
Radiation: Diode laser 980nm&100 mWatt
|
|
Primary Outcome(s)
|
|
Oral ulcer activity index
[Time Frame: One month]
|
|
Secondary Outcome(s)
|
|
Oral health - related quality of life
[Time Frame: One month]
|
|
Pain associated with oral ulcer
[Time Frame: One month]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|