AutoimmuneBDNCT03771768
Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease
A study testing Diode laser 980nm&100 mWatt and Triamcinolone Acetonide in people with Autoimmune and Behcet Syndrome, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autoimmune, Behcet Syndrome
- What is being tested?
- Diode laser 980nm&100 mWatt and Triamcinolone Acetonide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2019to 25 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Active Control,Randomized,Double- Blinded Clinical Trial of BD
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.
Read the 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.
- Conditions
- Autoimmune, Behcet Syndrome
- Being tested
- Diode laser 980nm&100 mWatt, Triamcinolone Acetonide
- Keywords
- Oral ulcers
- Medical subject headings
- Behcet Syndrome, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser 980nm&100 mWattRadiation
Also called Low level laser, Biostimulation, Soft laser
Diode laser 980 nm \&100 milli Watt.
Triamcinolone AcetonideDrug
Also called Topical corticosteroid
0.1 \&5gm paste 4 times/day
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone acetonide | Active comparator | Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month. Receives: Drug: Triamcinolone Acetonide |
| Diode laser | Experimental | Diode laser 980 nm \& 100mWatt. Receives: Radiation: Diode laser 980nm&100 mWatt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral ulcer activity index
Composite index score (0-10)
Measured: One month
Secondary outcomes (2)
Oral health - related quality of life
Oral health impact profile - 14 (OHIP- 14)
Measured: One month
Pain associated with oral ulcer
Visual analogue scale (0-10)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start25 May 2019 (estimated)
- Primary completion25 May 2019 (estimated)
- Study completion25 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutoimmuneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clair Sobhy Nagieb Botros, Cairo University
- Investigators
- Sherin Ali Hassan, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771768
- Sponsor's protocol ID
- 3:5:1
- Acronym
- BD
- Status last verified
- Feb 2019
- First submitted
- 1 Dec 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23622766Hatemi 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.
PubMed 24488418Nagieb 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.
PubMed 34212234
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Control,Randomized,Double- Blinded Clinical Trial of BD
- ClinicalTrials.gov ID
- NCT03771768
- Acronym / sponsor ID
- BD / 3:5:1
- Conditions
- Autoimmune, Behcet Syndrome
- Keywords
- Oral ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 May 2019 (estimated)
- Primary completion
- 25 May 2019 (estimated)
- Study completion
- 25 May 2019 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone AcetonideTriamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month. |
| Diode laser | Experimental | Radiation: Diode laser 980nm&100 mWattDiode laser 980 nm \& 100mWatt. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laser 980nm&100 mWattAlso: Low level laser, Biostimulation, Soft laserDiode laser 980 nm \&100 milli Watt. | Radiation | Diode laser |
| Triamcinolone AcetonideAlso: Topical corticosteroid0.1 \&5gm paste 4 times/day | Drug | Triamcinolone acetonide |
Primary outcome
Oral ulcer activity index
Time frame: One month
Composite index score (0-10)
2 secondary outcomes
Oral health - related quality of life
Time frame: One month
Pain associated with oral ulcer
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Background: PubMed 23622766Prasad 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.
- Background: PubMed 24488418Hatemi 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.
- Derived from this study: PubMed 34212234Nagieb 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherin Ali Hassan, MD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser 980nm&100 mWatt and Triamcinolone Acetonide in people with Autoimmune and Behcet Syndrome, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clair Sobhy Nagieb, MSC (01222259819 ext. Cairo U, Clair.nadieb@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral ulcer activity index (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.