Comparision of the efficacy of two treatment methods including baicalin mucoadhesive paste with betamethasone mouthwash and betamethasone mouthwash alone in patients with oral lichen planus
Comparision of the efficacy of two treatment methods including baicalin mucoadhesive paste with betamethasone mouthwash and betamethasone mouthwash alone in patients with oral lichen planus
Design
Randomized clinical trial, control group, on 36 patient
Settings and conduct
A case-control randomized clinical trial study will be conducted on patients with oral lichen planus referred to the Faculty of Dentistry in Tabriz University of mediccal science. Patients will be randomized into two groups. The participants in the case group will receive mucoadhesive baicalin paste with betamethasone mouthwash, and the control group will receive betamethasone mouthwash alone.
Participants/Inclusion and exclusion criteria
Patients with definite diagnosis of oral lichen planus based on clinical and histopathological findings
Patients with at least one visible and measurable ulcerative or atrophic or reticular lichen planus lesion.
Adult patients (over 18 years old)
Patients who have not received immunosuppressive drugs
Patients without underlying disease
Patients with complete records including clinical and demographic information
Smoking, alcohol consumption, caffeine
Immune system suppression
Presence of other simultaneous skin or mucosal lesions
Received treatment for oral lichen planus in the last 12 weeks
Lesions showing any dysplastic changes.
Unwillingness to participate in the study
Intervention groups
Eligible patients will be randomized into two groups. The participants in the case group will receive baicalin mucoadhesive paste with betamethasone mouthwash, and the participants in the control group will receive betamethasone mouthwash alone.
Main outcome variables
Clinical score based on Thongprasom scale
Pain score using Visual Analogue Scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241114063707N1
Registration date:2024-11-25, 1403/09/05
Registration timing:prospective
Last update:2024-11-25, 1403/09/05
Update count:0
Registration date
2024-11-25, 1403/09/05
Registrant information
Name
Mohadese Eslamzade hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 3883
Email address
m.eslamzade.d.s@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-20, 1403/09/30
Expected recruitment end date
2025-05-20, 1404/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the efficacy of two treatment methods including baicalin mucoadhesive paste with betamethasone mouthwash and betamethasone mouthwash alone in patients with oral lichen planus
Public title
Comparision of the efficacy of two treatment methods including baicalin mucoadhesive paste with betamethasone mouthwash and betamethasone mouthwash alone in patients with oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with definite diagnosis of oral lichen planus based on clinical and histopathological findings
Patients with at least one visible and measurable ulcerative or atrophic or reticular lichen planus lesion.
Adult patients (over 18 years old)
Patients who do not receive immunosuppressive drugs
Patients without underlying disease
Patients with complete records including clinical and demographic information
Exclusion criteria:
Smoking, alcohol consumption, caffeine
The presence of uncontrolled diabetes, hypertension and other underlying diseases that hinder participation in the study
Immune system suppression
Presence of other simultaneous skin or mucosal lesions
Received treatment for oral lichen planus in the last 12 weeks
Patients with oral candidiasis
Viral infections
Lesions showing any dysplastic changes.
Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
18 intervention envelopes and 18 control envelopes, which are identical , will be randomly numbered from 1 to 36. The randomization process will be done manually. The envelopes will remain sealed until the treatment begins. The distribution of the envelopes will follow the order of the patients on the list. Patients will be matched based on age and gender, and one of the researchers, who is aware of the treatment administered to the patient, will answer any questions the patients may have.
Blinding (investigator's opinion)
Single blinded
Blinding description
Eligible patients will be randomized into two groups. In this study, blinding will be done in such a way that the third researcher will be unaware of the treatment used for the patient and will only perform measurements and determine the clinical score. The questions of the patients will be answered by one of the researchers who is in the course of the treatment done for the patient. The third researcher and statistical analyst will be unaware of the content of the prescribed drug.
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, Attar street, Golgasht, Azadi Blv.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2024-08-19, 1403/05/29
Ethics committee reference number
IR.TBZMED.REC.1403.417
Health conditions studied
1
Description of health condition studied
oral lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
Clinical score based on Thongprasom scale
Timepoint
At the beginning of the intervention, 2 weeks later, 4 weeks later
Method of measurement
The clinical score will be based on Thongprasom's scale : Grade 0 = no lesion / normal mucosaGrade 1 = white striae / no erythematous areaGrade 2 = white striae with an atrophic area equal to or less than 1 cm2Grade 3 = white striae with an atrophic area greater than 1 cm2Grade 4 = white striae with an erogenous area equal to or less than 1 cm2Grade 5 = white striae with an erogenous zone greater than 1 cm2
2
Description
pain based on Visual Analogue Scale(VAS)
Timepoint
At the beginning of the intervention, 2 weeks later, 4 weeks later
Method of measurement
Pain will be evaluated using the Visual Analogue Scale including a 10 cm horizontal line (0 = no pain, 10 = the most severe pain experienced).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mucoadhesive baicalin with betamethasone mouthwash in patients with oral lichen planus. First, the plastibase base is prepared. This base is made of polyethylene and liquid paraffin, with the explanation that polyethylene is added to liquid paraffin at a rate of 5% by weight and volume, and the paraffin is melted and dissolved by heating. Then, it is spread on cold metal plates as a thin layer. When the plastibase base cools, it is formed. Baicalin is mixed with small amounts of base in a mortar and pestle using the geometric addition method, i.e., small amounts are mixed with small amounts of base to larger amounts in a mortar. Large amounts are placed under a mechanical stirrer to ensure the uniformity of baicalin distribution in the base. In the next step, the components of the mucoadhesive, namely pectin, gelatin, and sodium carboxymethyl cellulose, are added to the base in a ratio of one-third each and their total ratio to the base in a ratio equal to the geometric addition method under a mechanical stirrer. Care must be taken not to introduce water into the formulation at all stages. That is, completely dry containers should be used. It is better to completely dehydrate these mucoadhesive materials, namely pectin, gelatin and sodium carboxymethyl cellulose, in a 60 degree oven for 1 day before adding to the formula. The prepared formulation is filled in tubes and their containers are closed and stored in a dry environment, preferably a desiccator, until the patient uses it. Patients will receive baicalin mucoadhesive after brushing their teeth and then using betamethasone mouthwash. The mouthwash and then the mucoadhesive will be used three times a day. Patients will be followed up 2 and 4 weeks later. The parameters evaluated will include clinical scores based on Thongprasom’s scale and pain using VAS. Patients will be given instructions on how to use the medications.
Category
Treatment - Drugs
2
Description
Control group: Betamethasone mouthwash in patients with oral lichen planus: Standard routine treatment regimen will be used. Betamethasone mouthwash will be used three times a day. Patients will be followed up 2 and 4 weeks later. The parameters evaluated will include clinical score based on Thongprasom’s scale and pain using VAS. Patients will be given instruction on how to use the medications.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Faculty of Dentistry
Full name of responsible person
Mohadese Eslamzade Hesari
Street address
Attar street, Golgasht, Azadi Blv., Tabriz faculty of dentistry
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
Maryam Kouhsoltani
Street address
Attar street, Golgasht, Azadi Blv.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0310
Email
mkoohsoltani@yahoo.com
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 Kouhsoltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Attar street, Golgasht, Azadi Blv., 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 Kouhsoltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Attar street, Golgasht, Azadi Blv., 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
Mohadese Eslamzaede Hesari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No12,Baharestan alley, Haj Street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5174834938
Phone
+98 41 3477 3883
Email
m.eslamzade.d.s@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
Participants data file
When the data will become available and for how long