Erosive Oral Lichen PlanusNCT05951361
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus
A study testing 980nm Diode Laser and 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" in people with Erosive Oral Lichen Planus, run by Alexandria University at 1 site in Egypt.
Trial summary
this study evaluates the effect of diode laser in treatment of oral lichen planus. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Erosive Oral Lichen Planus
- What is being tested?
- 980nm Diode Laser and 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 10 Apr 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient histologically diagnosed with erosive OLP based on WHO modified criteria 2003.
- Presence of painful erosive OLP lesions diagnosed by biopsy
Who cannot join
- Pregnant or breast-feeding women
- Patients currently treated for cancer with Chemotherapy or Radiotherapy
- Patient currently on Corticosteroid therapy or had this treatment on the past 3 months
- Those who had used Anti-inflammatory drugs topical or systemic in the last month
- the use of drugs related to Oral Lichenoid Lesions
- Presence of Amalgam restorations near the OLP lesions
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- dysplasia in histopathological examination
- uncontrolled systemic diseases
- physical or mental abnormality which would interfere with or be affected by the study procedure
- Patients with skin lesion
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology
Alexandria, Alexandria Governorate, 21648
About this study
Official title: Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
this study evaluates the effect of diode laser in treatment of oral lichen planus.
Read the detailed description
44 patients with erosive oral lichen planus were included in the study and divided into 2 equal groups. Group I received topical steroid therapy three times daily for 4 weeks and antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to 10 sessions.
- Conditions
- Erosive Oral Lichen Planus
- Being tested
- 980nm Diode Laser, 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
980nm Diode LaserDevice
300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions
0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"Drug
Also called Kenacourt-A Orabase
three times daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Kenacourt-A Orabase | Active comparator | the patients in this group received steroid therapy" Kenacourt-A Orabase" three times daily for 4 weeks.
antifungal drug "miconazole oral gel" once daily for 1 week Receives: Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" |
| 980nm Diode Laser | Active comparator | the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions Receives: Device: 980nm Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain from the base line to 12 weeks follow-up
Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever
Measured: base line, 6weeks and 12 weeks
Secondary outcomes (1)
change of clinical score of the lesion from the base line to 12 weeks follow-up
The size of the lesion is monitored where score 0 no lesions, score 1 : mild white striation only, score 2 : white striation with erythematous area < 1 cm 2, score 3 : white striation with erythematous area > 1 cm 2, score 4 : white striation < 1 cm2, score 5 : white striation with erosive area > 1 cm2.
Measured: base line, 6weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Feb 2022
- Primary completion10 Feb 2023
- Study completion10 Apr 2023
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 Erosive Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naguiba Mahmoud, Prof, Study director, department of oral medicine, faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951361
- Sponsor's protocol ID
- 0369-01/2022
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to the data may be extended beyond the initial 24-month period upon request and approval, which will also be evaluated on a case-by-case basis.
Publications
Cafaro A, Arduino PG, Massolini G, Romagnoli E, Broccoletti R. Clinical evaluation of the efficiency of low-level laser therapy for oral lichen planus: a prospective case series. Lasers Med Sci. 2014 Jan;29(1):185-90. doi: 10.1007/s10103-013-1313-6. Epub 2013 Apr 3.
PubMed 23549680Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002.
PubMed 24887747Mohamed RK, Elsayed NM, Mahmoud SA, Gaweesh YY. Photobiomodulation versus corticosteroid in the management of erosive oral lichen planus: a randomized controlled clinical trial. BMC Oral Health. 2024 Feb 17;24(1):246. doi: 10.1186/s12903-024-03976-6.
PubMed 38365694
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05951361
- Acronym / sponsor ID
- 0369-01/2022
- Conditions
- Erosive Oral Lichen Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 19 Jul 2023 (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.
this study evaluates the effect of diode laser in treatment of oral lichen planus.
Detailed description
44 patients with erosive oral lichen planus were included in the study and divided into 2 equal groups. Group I received topical steroid therapy three times daily for 4 weeks and antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to 10 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kenacourt-A Orabase | Active comparator | Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"the patients in this group received steroid therapy" Kenacourt-A Orabase" three times daily for 4 weeks. antifungal drug "miconazole oral gel" once daily for 1 week |
| 980nm Diode Laser | Active comparator | Device: 980nm Diode Laserthe patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient histologically diagnosed with erosive OLP based on WHO modified criteria 2003.
- Presence of painful erosive OLP lesions diagnosed by biopsy
Key exclusion criteria (10 listed)
- Pregnant or breast-feeding women
- Patients currently treated for cancer with Chemotherapy or Radiotherapy
- Patient currently on Corticosteroid therapy or had this treatment on the past 3 months
- Those who had used Anti-inflammatory drugs topical or systemic in the last month
- the use of drugs related to Oral Lichenoid Lesions
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 |
|---|---|---|
| 980nm Diode Laser300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions | Device | 980nm Diode Laser |
| 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"Also: Kenacourt-A Orabasethree times daily for 4 weeks | Drug | Kenacourt-A Orabase |
Primary outcome
change of pain from the base line to 12 weeks follow-up
Time frame: base line, 6weeks and 12 weeks
Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever
1 secondary outcome
change of clinical score of the lesion from the base line to 12 weeks follow-up
Time frame: base line, 6weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 23549680Cafaro A, Arduino PG, Massolini G, Romagnoli E, Broccoletti R. Clinical evaluation of the efficiency of low-level laser therapy for oral lichen planus: a prospective case series. Lasers Med Sci. 2014 Jan;29(1):185-90. doi: 10.1007/s10103-013-1313-6. Epub 2013 Apr 3.
- Background: PubMed 24887747Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002.
- Derived from this study: PubMed 38365694Mohamed RK, Elsayed NM, Mahmoud SA, Gaweesh YY. Photobiomodulation versus corticosteroid in the management of erosive oral lichen planus: a randomized controlled clinical trial. BMC Oral Health. 2024 Feb 17;24(1):246. doi: 10.1186/s12903-024-03976-6.
- Individual participant dataSharing planned: Yes. Access to the data may be extended beyond the initial 24-month period upon request and approval, which will also be evaluated on a case-by-case basis.
Related trials for Erosive Oral Lichen Planus
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Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.
Oral Lichen Planus, Erosive Lichen Planus
RecruitingPhase 1/2
Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus
Oral Erosive Lichen Planus
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.
Naguiba Mahmoud, Prof study director
department of oral medicine, faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 980nm Diode Laser and 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" in people with Erosive Oral Lichen Planus, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pain from the base line to 12 weeks follow-up (time frame: base line, 6weeks and 12 weeks). 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 NCT05951361, 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 19 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.