Comparison of the Effect of Gamma-oryzanol Mucoadhesive paste with Betamethasone Mouthwash and Betamethasone Mouthwash Alone on Clinical Manifestations and Pain Severity in Oral Lichen Planus Patients
Comparison of the effect of gamma-oryzanol mucoadhesive paste along with betamethasone mouthwash and betamethasone mouthwash alone on clinical manifestations and pain intensity in patients with oral lichen planus
Design
Clinical trial, with a control group, with parallel groups, randomized, on 38 patients
Settings and conduct
It is a double-blind randomized trial study on 38 patients with oral lichen planus referred to Tabriz University of Medical Sciences Faculty of Dentistry in order to compare the effect of gamma-oryzanol with betamethasone mouthwash on the treatment of oral planus lichen. People are placed in two groups A and B based on a random sequence by a third person (other than the main researcher). The case group received gamma-oryzanol mucoadhesive along with betamethasone mouthwash and the control group received betamethasone mouthwash.
Participants/Inclusion and exclusion criteria
Entry criteria: definitive diagnosis of oral lichen planus based on clinical and histopathological findings of patients with at least one visible and measurable ulcerative or atrophic or reticular lichen planus lesion, absence of dysplasia, age over 18 years, absence of underlying disease
Exclusion criteria: pregnancy and breastfeeding, uncontrolled diabetes, blood pressure and other underlying diseases
Allergy to betamethasone mouthwash or gamma-oryzanol , use of drugs that cause lichenoid reaction or the presence of amalgam repair in the vicinity of the lesion, the presence of skin or other mucosal lesions, patients with oral candidiasis, viral infections, receiving treatment for oral lichen planus During the last 12 weeks
Intervention groups
Case: 19 patients who receive gamma-oryzanol mucoadhesive along with betamethasone mouthwash.
Control: 19 patients taking betamethasone mouthwash
Main outcome variables
Clinical score based on Thongprasom's scale, pain score using Visual Analogue Scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250106064298N1
Registration date:2025-02-18, 1403/11/30
Registration timing:prospective
Last update:2025-02-18, 1403/11/30
Update count:0
Registration date
2025-02-18, 1403/11/30
Registrant information
Name
Sara Hasan Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4422 5563
Email address
sarahasannejad9801@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Gamma-oryzanol Mucoadhesive paste with Betamethasone Mouthwash and Betamethasone Mouthwash Alone on Clinical Manifestations and Pain Severity in Oral Lichen Planus Patients
Public title
Effect of Gamma-oryzanol in Lichen Planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of Oral Lichen Planus based on clinical and histopathological findings of patients with at least one visible and measurable ulcerative or atrophic or reticular Oral Lichen Planus lesion
Patients who have not received immunosuppressive drugs
Absence of dysplasia
Absence of underlying disease
Completeness of the file including demographic and clinical information
Exclusion criteria:
Allergy to betamethasone or gamma-oryzanol mouthwash
There are only reticular lines in the patient's mouth and the lichen planus is painless
The presence of uncontrolled diabetes
Blood pressure and other underlying diseases that can interfere with participation and compliance with the study
Immunosuppression
Hepatitis (because corticosteroid suppresses the immune system and increases the likelihood of viremia)
The use of lichenoid reaction drugs or the presence of amalgam repair in the vicinity of the lesion
The presence of skin or other mucosal destruction lesions
Patients with oral candidiasis
Receiving treatment for oral lichen planus in the past 12 weeks
Viral infections
Pregnancy and breastfeeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting eligible patients, randomization will be done by envelope method and divided into two groups with equal distribution of groups. Patients are matched in terms of age and sex, and the third researcher will perform randomization. A third investigator will not participate in any assessment during or after treatment. The study group (case or control) will be placed inside identical envelopes marked with consecutive numbers. Envelopes will be sealed until treatment begins.
Blinding (investigator's opinion)
Double blinded
Blinding description
Two drugs are prepared and assigned in the same form and in the same envelopes to the number of members of each group by a trained third person from number 1 to 38 for two groups so that none of the researchers and patients know about the contents of the package.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2024-12-29, 1403/10/09
Ethics committee reference number
IR.TBZMED.REC.1403.773
Health conditions studied
1
Description of health condition studied
Symptomatic oral lichen planus lesions
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
Clinical score based on Thongprasom's scale
Timepoint
At the beginning of the intervention, 4 weeks later, 8 weeks later, 12 weeks later
Method of measurement
The clinical score will be calculated based on Thongprasom's scale: grade 0 = no lesion / normal mucosa grade 1 = white striae / no erythematous area grade 2 = white striae with an atrophic area equal to or less than 1 cm2 grade 3 = white striae with area Atrophic more than 1 cm2 grade 4 = white stretch marks with erogenous area equal to or less than 1 cm2 grade 5 = white stretch marks with erogenous area more than 1 cm square meter
2
Description
Pain score using Visual Analogue Scale
Timepoint
At the beginning of the intervention, 4 weeks later, 8 weeks later, 12 weeks later
Method of measurement
Pain will be evaluated using the VAS (Visual Analogue Scale) scale, which includes a 10 cm horizontal line from 0 = no pain, to 10 = the most severe pain experienced, and the patient chooses a number based on the pain intensity.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the beginning, plastic base is prepared. This base is made of polyethylene and liquid paraffin, with the explanation that polyethylene is added to liquid paraffin at the rate of 5% by weight and it melts and dissolves by heating the paraffin. Then it is spread in a thin layer on cold metal plates. By cooling the plastic base, the base is formed. Gamma-oryzanol is added by geometrical method, that is, its small amounts are mixed with small amounts of base up to larger amounts in a mortar. Its larger amounts are put under a mechanical stirrer to ensure the uniformity of gamma-oryzanol distribution in the base. In the next step, the components of the adhesive mucus, i.e. pectin, gelatin and sodium carboxymethyl cellulose, are added to the base with a ratio of one third each and their total ratio to the base with an equal ratio using the geometrical addition method under a mechanical stirrer. Care should be taken to ensure that water does not enter the formulation at all stages. It means to use completely dry dishes. It is better to completely dehydrate these mucous adhesive materials, i.e. pectin, gelatin and sodium carboxymethyl cellulose, before adding them to the formula for 1 day in a 60 degree oven. The prepared formulation is filled in tubes and their containers are closed and stored in a dry environment, preferably a desiccator, until use by the patient. After brushing and then using betamethasone mouthwash, patients will receive gamma-oryzanol adhesive mucus for 8 weeks. Mouthwash followed by adhesive mucus will be used three times a day. Patients will be followed up 4, 8 and 12 weeks later. The evaluated parameters will include clinical score based on Thongprasom's scale and pain using VAS. Patients will be taught how to use drugs.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will use the standard routine treatment regimen. Betamethasone mouthwash is used for 8 weeks after brushing. Mouthwash will be used three times a day. Patients will be followed up 4, 8 and 12 weeks later. The evaluated parameters will include clinical score based on Thongprasom's scale and pain using VAS. Patients will be taught how to use drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Faculty of Dentistry
Full name of responsible person
Sara Hasannejad
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 3298
Email
info@dentistryfac.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosro Adib Kia
Street address
Research and Technology Vice-Chancellor, 3rd Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Kooh Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0310
Email
mkoohsoltani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Kooh Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0310
Email
mkoohsoltani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sara Hasan Nejad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 44 4422 5563
Fax
Email
sarahasannejad9801@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participant data file, information related to the main outcome
When the data will become available and for how long
18 months after the study
To whom data/document is available
Data is published
Under which criteria data/document could be used
In case of citation
From where data/document is obtainable
Sara hasannejad, sarahasannejad9801@gmail.com
What processes are involved for a request to access data/document
By communicating with the person in charge of the update