Oral lichen planus
Conditions
Interventions
Mouthwash with SORB's ORAL WASH (hold approximately 10 ml in mouth and rinse for 20 seconds then spit out) twice a day, morning and evening after meals, for 4 weeks.
Sponsors
Yagyuu Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or more 2. Patients with clinically or histopathologically diagnosed oral lichen planus 3. Patients with oral lichen planus corresponding to Grade1 of the Classification of Oral Mucositis Severity (CTCAE v5.0) 4. Patients who have given written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients who cannot chew gum for 5 minutes 2. Patients who cannot rinse their mouth with mouthwash 3. Patients taking etretinate 4. Patients taking cephalantin 5. Patients using steroidal oral ointments 6. Patients who have used mouthwash or gargling agents at least once within the past month 7. Patients who receiving or planning to receive systemic administration of antibacterial agents 8. Patients who have difficulty giving valid informed consent 9. Patients who are judged by the principal investigator or subinvestigator to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the ratio of periodontopathogenic bacteria Red-complex (Treponema denticola, Tannerella forsythia, Porphyromonas gingivalis) in saliva at the time of stimulation to the total number of bacteria (comparison between at case enrollment and 4 weeks after enrollment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Efficacy 1. Change in the amount of the following bacteria in saliva at the time of stimulation (comparison between at the time of enrollment and 4 weeks after enrollment) - Treponema denticola - Tannerella forsythia - Porphyromonas gingivalis 2.Change in the total number of bacteria in saliva at the time of stimulation (comparison between at the time of enrollment and 4 weeks after enrollment) 3.Change in the ratio of the following bacteria in saliva at the time of stimulation to the total number of bacteria (comparison between at the time of enrollment and 4 weeks after enrollment) - Treponema denticola - Tannerella forsythia - Porphyromonas gingivalis 4. Change in the ratio of the top 10 most abundant bacteria detected in saliva at the time of stimulation by 16S metagenome analysis (comparison between enrollment and 4 weeks after enrollment) 5. Change in the score by Thongprasom score classification (comparison between at case enrollment compared to 4 weeks after enrollment) Safety evaluation Occurrence of adverse events under the Clinical Trials Act | — |
Contacts
Public ContactTakahiro Yagyuu
Nara medical university Hospital
Outcome results
None listed