Protocol summary

Study aim
Comparison of Two Corticosteroid Mouthwashes, Betamethasone and Dexamethasone, in the Treatment of Patients with Aphthous Stomatitis and Oral Lichen Planus
Design
In the second intervention group, a combination of 6 vials of dexamethasone ampoules, nystatin drops (100,000 units), aluminum hydroxide syrup (40 mg), and diphenhydramine syrup (160 mg) was prepared. Patients then used the dexamethasone mouthwash three times a day for 2 minutes each time, over a period of 14 days.
Settings and conduct
This double-blind study will be conducted at the Dental Clinic of the Faculty of Dentistry in Isfahan. In this double-blind study, patients were informed about their participation, while both the researchers and participants were kept blinded to group allocation. To achieve this, identical unlabeled bottles were prepared and assigned to patients using confidential coding. Patients were instructed not to eat or drink for up to 30 minutes after using the mouthwash.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Informed consent; Aged 18 years and older; Clinical and pathological diagnosis of oral aphthous stomatitis or lichen planus; Appropriate general health Exclusion criteria:Receipt of topical or systemic corticosteroids within the past three months; Known hypersensitivity to betamethasone or dexamethasone; Presence of severe or impactful systemic and underlying diseases; History of oral fungal infections pregnancy or breastfeeding
Intervention groups
In the first intervention group, a combination of 6 vials of betamethasone ampoules, nystatin drops (100,000 units), aluminum hydroxide syrup (40 mg), and diphenhydramine syrup (160 mg) was prepared. Patients then used the betamethasone mouthwash three times a day for 2 minutes each time, over a period of 14 days.
Main outcome variables
Allergy and oral thrush; Dry mouth; Pain severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N282
Registration date: 2026-07-31, 1405/05/09
Registration timing: prospective

Last update: 2026-07-31, 1405/05/09
Update count: 0
Registration date
2026-07-31, 1405/05/09
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-16, 1405/05/25
Expected recruitment end date
2026-09-16, 1405/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two types of corticosteroid mouthwashes, Betamethasone and Dexamethasone, in the treatment of patients with aphthous stomatitis and lichen planus
Public title
Comparison of corticosteroid mouthwashes, Betamethasone and Dexamethasone, in the treatment of patients with aphthous stomatitis and lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Aged 18 years and older Clinical and pathological diagnosis of oral aphthous stomatitis or lichen planus Appropriate general health
Exclusion criteria:
Receipt of topical or systemic corticosteroids within the past three months Known hypersensitivity to betamethasone or dexamethasone Presence of severe or impactful systemic and underlying diseases (e.g., uncontrolled diabetes, renal failure, active cancer Use of corticosteroids and immunosuppressive agents History of oral fungal infections pregnancy or breastfeeding Tobacco use (cigarettes or hookah)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients are informed about their participation in the study. Both the researchers and participants were kept blinded to group allocation. To achieve this, identical unlabeled bottles were prepared and given to the patients using confidential coding
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Esfahan
Province
Isfehan
Postal code
8155139998
Approval date
2026-07-07, 1405/04/16
Ethics committee reference number
IR.IAU.KHUISF.REC.1405.160

Health conditions studied

1

Description of health condition studied
oral aphthae
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae

2

Description of health condition studied
Lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus

Primary outcomes

1

Description
Pain intensity
Timepoint
Beginning of study and end of study
Method of measurement
Based on visual pain scale

2

Description
Dry Mouth
Timepoint
Beginning of study and end of study
Method of measurement
Visit by a doctor

3

Description
Allergy and oral fungus
Timepoint
Beginning of study and end of study
Method of measurement
Visit by a doctor

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group, a combination of 6 vials of betamethasone ampoules, nystatin drops (100,000 units), aluminum hydroxide syrup (40 mg), and diphenhydramine syrup (160 mg) was prepared. Patients then used the betamethasone mouthwash three times a day for 2 minutes each time, over a period of 14 days.
Category
Treatment - Other

2

Description
In the second intervention group, a combination of 6 vials of dexamethasone ampoules, nystatin drops (100,000 units), aluminum hydroxide syrup (40 mg), and diphenhydramine syrup (160 mg) was prepared. Patients then used the dexamethasone mouthwash three times a day for 2 minutes each time, over a period of 14 days.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Clinic, Faculty of Dentistry
Full name of responsible person
Dr. Hamid Taherinia
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Esfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4003
Email
taherinia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Khorasgan branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Hamid Taherinia
Position
Resident of Oral and Maxillofacial Diseases
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Esfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4003
Email
taherinia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Amir Mansour Shirani
Position
Faculty Member of the University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Esfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4003
Email
shirani324@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Amir Mansour Shirani
Position
Faculty Member of the University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Esfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4003
Email
shirani324@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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