Oral Lichen PlanusPhase 1NCT06681090
Different Treatment Modalities for Oral Lichen Plan
A Phase 1 study testing 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" and 980 nm diode laser in people with Oral Lichen Planus, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of applications of Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus is to learn if intervention can by relieve pain, decreasing inflammation, and facilitating tissue healing in20 patients who were suffering from erosive oral lichen planus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" and 980 nm diode laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2023to 29 Oct 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who were monitored for OLP.
- clinical and histopathological finding of OLP in accordance with van der Meij 2003.
- being over 18 years old.
Who cannot join
- Patients with systemic disorders, pregnancy, using drugs, smoking, lesions in contact with dental amalgams, and cutaneous or other mucosal involvement at the time of treatment were excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Assiut University
Asyut, Asyut Governorate, 71515
About this study
Official title: Effectiveness of Low-Level Laser Therapy and Topical Steroid Therapy in the Management of Oral Lichen Planus
The goal of applications of Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus is to learn if intervention can by relieve pain, decreasing inflammation, and facilitating tissue healing in20 patients who were suffering from erosive oral lichen planus. The main questions it aims to answer are which is better and more effective as treatment modality. The erosion size (mm2) measured on the first day and 4 weeks later. Oral Health-Related Quality of Life questionnaire manipulated. Researchers will take Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus to see if it could be used as separate treatment option or as combination.
- Conditions
- Oral Lichen Planus
- Being tested
- 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase", 980 nm diode laser
- Keywords
- Low-Level Laser, Topical Steroid, 0.1% triamcinolone acetonide, management of oral lichen planus
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"Drug
The patients were administered topical corticosteroids in the form of a 0.1% triamcinolone acetonide preparation (Kenacort TM 0.1% Abbott). The medication was to be used 3 times every day for 4 weeks or until the lesion has healed, whichever occurs first. After applying the gel, the patients were instructed not to consume any fluids or food for at least 1 hour. In addition, a topical antifungal treatment consisting of Miconazole oral gel at a concentration of 2% should be applied once a day for 4 weeks
980 nm diode laserDevice
First group (Group A) underwent PBM therapy using a 980 nm diode laser (elexxion nano dental laser with a flat top handpiece). The therapy included 8 sessions for 4 weeks, with 2 sessions conducted per week, all administered by the same operator. The energy was evenly distributed across all the mucosal lesions and the surrounding tissues within a 0.5 cm range using a spot-technique method with little overlap.
| Study group | Role | What they receive |
|---|---|---|
| Topical Steroid Therapy of Erosive oral lichen planus | Experimental | topical application of 0.1% triamcinolone acetonide and photo biomodulation on erosive oral lichen planus, 3 times daily and a miconazole oral gel once daily, for 4 weeks Receives: Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" |
| Low-Level Laser Therapy of Erosive oral lichen planus | Experimental | Photo biomodulation with laser therapy twice a week for 8 sessions over 4 weeks, utilizing a 980 nm diode laser with an output power of 300 mw. Receives: Device: 980 nm diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The erosion size
The maximal diameter (mm) and width (mm) were measured perpendicularly using a calibrated periodontal probe
Measured: From enrollment to the end of treatment at 4 weeks"
The Visual Analogue Scale (VAS)
pain ratings span from zero (indicating the absence of pain) to 10 (representing extremely intense pain) along a horizontal line values. { the minimum is 0 and maximum is 10 }
Measured: From enrollment to the end of treatment at 4 weeks"
Secondary outcomes (1)
Oral Health-Related Quality of Life (OHRQoL)
A month following the initial appointment, participants were asked about the OLP that had restricted their everyday activities. The 8 tasks included eating, talking, cleaning one's mouth, sleeping, smiling, laughing freely, maintaining emotional stability, performing strenuous physical labour, and interacting with others. { the minimum is 0 and maximum values is 5 }.a score of zero indicated never being afflicted, a score of 1 meant once a month, a score of 2 meant twice a month, scoring 3 indicated a frequency of once or twice weekly, 4 indicated 3 to 4 times weekly, and 5 signified daily or very daily occurrences.
Measured: From enrollment to the end of treatment at 4 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start3 Mar 2023
- Primary completion25 Sep 2023
- Study completion29 Oct 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 Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Asem Mohammed Kamel Ali, Al-Azhar University
- Investigators
- Ahmed F. Assistant Professor, PhD, Principal investigator, Faculty of Dentistry, Assiut University, EgyptRahma M. Lecturer, PhD, Principal investigator, Faculty of Dentistry, Assiut University, EgyptAsem K. Lecturer, PhD, Study chair, Dental Medicine Faculty, Al-Azhar University (Assiut Branch), Assiut, EgyptMahmoud A. Professor, PhD, Study director, Faculty of Dentistry, Al-Azhar University (Assiut Branch), Assiut, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681090
- Sponsor's protocol ID
- Management of Oral Lichen Plan
- Status last verified
- Feb 2025
- First submitted
- 2 Nov 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Meij EH, Schepman KP, van der Waal I. The possible premalignant character of oral lichen planus and oral lichenoid lesions: a prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Aug;96(2):164-71. doi: 10.1016/s1079-2104(03)00305-6.
PubMed 12931088Ruiz Roca JA, Lopez Jornet P, Gomez Garcia FJ, Marcos Aroca P. Effect of Photobiomodulation on Atrophic-Erosive Clinical Forms of Oral Lichen Planus: A Systematic Review. Dent J (Basel). 2022 Nov 27;10(12):221. doi: 10.3390/dj10120221.
PubMed 36547037Bhatt G, Gupta S, Ghosh S. Comparative efficacy of topical aloe vera and low-level laser therapy in the management of oral lichen planus: a randomized clinical trial. Lasers Med Sci. 2022 Apr;37(3):2063-2070. doi: 10.1007/s10103-021-03480-1. Epub 2021 Dec 1.
PubMed 34853932
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low-Level Laser Therapy and Topical Steroid Therapy in the Management of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT06681090
- Acronym / sponsor ID
- Management of Oral Lichen Plan
- Conditions
- Oral Lichen Planus
- Keywords
- Low-Level Laser, Topical Steroid, 0.1% triamcinolone acetonide, management of oral lichen planus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 8 Nov 2024 (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.
The goal of applications of Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus is to learn if intervention can by relieve pain, decreasing inflammation, and facilitating tissue healing in20 patients who were suffering from erosive oral lichen planus. The main questions it aims to answer are which is better and more effective as treatment modality. The erosion size (mm2) measured on the first day and 4 weeks later. Oral Health-Related Quality of Life questionnaire manipulated. Researchers will take Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus to see if it could be used as separate treatment option or as combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Steroid Therapy of Erosive oral lichen planus | Experimental | Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"topical application of 0.1% triamcinolone acetonide and photo biomodulation on erosive oral lichen planus, 3 times daily and a miconazole oral gel once daily, for 4 weeks |
| Low-Level Laser Therapy of Erosive oral lichen planus | Experimental | Device: 980 nm diode laserPhoto biomodulation with laser therapy twice a week for 8 sessions over 4 weeks, utilizing a 980 nm diode laser with an output power of 300 mw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who were monitored for OLP.
- clinical and histopathological finding of OLP in accordance with van der Meij 2003.
- being over 18 years old.
Key exclusion criteria (1 listed)
- Patients with systemic disorders, pregnancy, using drugs, smoking, lesions in contact with dental amalgams, and cutaneous or other mucosal involvement at the time of treatment were excluded.
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 |
|---|---|---|
| 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"The patients were administered topical corticosteroids in the form of a 0.1% triamcinolone acetonide preparation (Kenacort TM 0.1% Abbott). The medication was to be used 3 times every day for 4 weeks or until the lesion has healed, whichever occurs first. After applying the gel, the patients were instructed not to consume any fluids or food for at least 1 hour. In addition, a topical antifungal treatment consisting of Miconazole oral gel at a concentration of 2% should be applied once a day for 4 weeks | Drug | Topical Steroid Therapy of Erosive oral lichen planus |
| 980 nm diode laserFirst group (Group A) underwent PBM therapy using a 980 nm diode laser (elexxion nano dental laser with a flat top handpiece). The therapy included 8 sessions for 4 weeks, with 2 sessions conducted per week, all administered by the same operator. The energy was evenly distributed across all the mucosal lesions and the surrounding tissues within a 0.5 cm range using a spot-technique method with little overlap. | Device | Low-Level Laser Therapy of Erosive oral lichen planus |
Primary outcome
The erosion size
Time frame: From enrollment to the end of treatment at 4 weeks"
The maximal diameter (mm) and width (mm) were measured perpendicularly using a calibrated periodontal probe
The Visual Analogue Scale (VAS)
Time frame: From enrollment to the end of treatment at 4 weeks"
pain ratings span from zero (indicating the absence of pain) to 10 (representing extremely intense pain) along a horizontal line values. { the minimum is 0 and maximum is 10 }
1 secondary outcome
Oral Health-Related Quality of Life (OHRQoL)
Time frame: From enrollment to the end of treatment at 4 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 7 Feb 2025.
- Background: PubMed 12931088van der Meij EH, Schepman KP, van der Waal I. The possible premalignant character of oral lichen planus and oral lichenoid lesions: a prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Aug;96(2):164-71. doi: 10.1016/s1079-2104(03)00305-6.
- Background: PubMed 36547037Ruiz Roca JA, Lopez Jornet P, Gomez Garcia FJ, Marcos Aroca P. Effect of Photobiomodulation on Atrophic-Erosive Clinical Forms of Oral Lichen Planus: A Systematic Review. Dent J (Basel). 2022 Nov 27;10(12):221. doi: 10.3390/dj10120221.
- Background: PubMed 34853932Bhatt G, Gupta S, Ghosh S. Comparative efficacy of topical aloe vera and low-level laser therapy in the management of oral lichen planus: a randomized clinical trial. Lasers Med Sci. 2022 Apr;37(3):2063-2070. doi: 10.1007/s10103-021-03480-1. Epub 2021 Dec 1.
- Individual participant dataSharing planned: No
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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.
Ahmed F. Assistant Professor, PhD principal investigator
Faculty of Dentistry, Assiut University, Egypt
Rahma M. Lecturer, PhD principal investigator
Faculty of Dentistry, Assiut University, Egypt
Asem K. Lecturer, PhD study chair
Dental Medicine Faculty, Al-Azhar University (Assiut Branch), Assiut, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" and 980 nm diode laser in people with Oral Lichen Planus, run by Al-Azhar 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 3 inclusion and 1 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 7 Feb 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The erosion size (time frame: From enrollment to the end of treatment at 4 weeks"). The study lists 2 primary outcomes in all. 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 NCT06681090, 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 7 Feb 2025.