Determining the therapeutic effect of a formulated mouthwash containing dexamethasone and fluconazole on oral lichen planus
Design
A phase III randomized clinical trial study with a control group is designed for 70 patients. Randomization is performed using a computerized random number table.
Settings and conduct
This randomized clinical trial is being conducted at Mashhad Dental School. Randomization is done using the sealed envelope method. Random numbers are generated with the help of the Randomaize.com website. The printed sheets will be placed inside the envelope. The envelopes will be closed and . Based on the contents of the envelope, the individual will be assigned to the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults over 18 and under 65 years of age
People who are prescribed mouthwash due to the number or extent of pathological lesions, as approved by a specialist, and the severity of the lesions is equal to two or more according to the Thongprsom criteria.
Those who have informed consent to participate in the study
exclusion criteria:
Severe problems due to systemic diseases (more than two according to the ASA classification).
People who are unable to rinse their mouth with topical corticosteroids due to systemic or medication reasons.
People who have severe dysplasia based on the pathology results
People who, for whatever reason, do not wish to continue participating in the project.
People who have allergies to the drug or a history of allergies to other components of the formulation.
Topical and systemic use of corticosteroid medications in the last 3 weeks
Pregnant and breastfeeding women
Immunocompromised patients
Intervention groups
5 ml of a mouthwash formulated with dexamethasone 0.1 mg/ml + fluconazole 2 mg/ml, 3 times a day for 3 weeks
Main outcome variables
Severity of oral lichen planus lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250715066509N1
Registration date:2025-08-18, 1404/05/27
Registration timing:prospective
Last update:2025-08-18, 1404/05/27
Update count:0
Registration date
2025-08-18, 1404/05/27
Registrant information
Name
Ehsan Jannat Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
jannatabadie4031@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-06-21, 1405/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of formulated mouthwash containing dexamethasone and fluconazole on oral lichen planus
Public title
Investigating the effect of dexamethasone and fluconazole mouthwash on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults over 18 and under 65 years of age
People who are prescribed mouthwash due to the number or extent of pathological lesions, as approved by a specialist, and the severity of the lesions is equal to two or more according to the Thongprsom criteria.
Those who have informed consent to participate in the study
Exclusion criteria:
Severe problems due to systemic diseases (more than two according to the ASA classification).
People who are unable to rinse their mouth with topical corticosteroids due to systemic or medication reasons.
People who have severe dysplasia based on the pathology results
People who, for whatever reason, do not wish to continue participating in the project.
People who have allergies to the drug or a history of allergies to other components of the formulation.
Topical and systemic use of corticosteroid medications in the last 3 weeks
Pregnant and breastfeeding women
Immunocompromised patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelope
Sealed envelope method: The envelopes are prepared and printed by a member of the research team and random numbers are generated with the help of the website Randomaize.com. The printed sheets will be placed inside the envelope. The envelopes will be closed and their contents will not be visible from the outside. Then, initially, the purpose of the study is explained to the person who meets the conditions for entering the study and, if desired, they sign the informed consent form and take an envelope. Then, it is opened and based on the contents of the envelope, the person is entered into the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences- Research Ethics Committee