Evaluation and comparison of efficacy of Henna Mouthwash and Chlorhexidine Mouthwash on signs and symptoms of Oral Lichen Planus Lesions treated with topical corticosteroid
Design
Randomized, double blinded, clinical trial. randomization will be done by pharmacologist.
Settings and conduct
The patients who presented with chief complaint from burning sensation of oral mucosa to Kerman dentistry university since 1390. topical steroid is prescribed for all of them as the main treatment. Neither patient nor clinician doesn't know which mouthwashes (Chlorhexidine or Henna) they receive. Pharmacist keeps mouthwashes in the same bottles(250 cc) and marks with numbers(1-40).
Participants/Inclusion and exclusion criteria
patients who have OLP, referred to Kerman dental school since 1390 and did not have histology signs of dysplasia. they did not use drugs with lichenoid reactions.
Intervention groups
All patients will receive Betamethasone lotion as a topical steroid(the standard treatment for oral lichen planus). The control group patients will receive Chlorhexidine mouthwash and the intervention group,will receive Henna mouthwash as adjuvant therapy and according to this, the antimicrobial effect of these two mouthwashes is compared.
Main outcome variables
Signs and symptoms of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181204041844N1
Registration date:2020-06-02, 1399/03/13
Registration timing:retrospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
nahid karbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3244 8668
Email address
n.karbasi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2020-03-02, 1398/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Chlorhexidine gluconate 0.2% mouthwash with Henna mouthwash as adjuvant therapy on oral lichen planus
Public title
evaluation the effect of henna mouthwash on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of atrophic and/or erosive lesions of the oral mucosa
Painful lesions
Histological confirmation of the diagnosis of oral lichen
Exclusion criteria:
presence of dysplasia in the histopathological study of OLP
patients on long-term corticosteroid therapy
the use of drugs capable of inducing lichenoid reactions
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by the Randlist software and each patient will be entered in the treatment or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researcher and participants until the final analyses are completed. The researcher at the Kerman dental school, who is not aware of random sequences, will deliver the participants to 250cc opaque glass containers that have a similar appearance and contain a mouthwash.The taste and smell of henna and chlorhexidine mouthwashes are similar due to its 2% ethanol content.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman, the center of seven Alavi Gardens, Campus of Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
1355576169
Approval date
2639-09-19, 2018/06/28
Ethics committee reference number
1396.2417
Health conditions studied
1
Description of health condition studied
"oral lichen planus"
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
pain intensity
Timepoint
before intervention and 7,14 days after intervention
Method of measurement
Visual Analogue Scale
2
Description
clinical presentation or inflammation
Timepoint
before intervention and 7,14 days after intervention
Method of measurement
Thongprasom sign Scoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Mouthwash 2% of the aqueous extract of Henna plant in the presence of other mouthwash compounds containing 0.1% w / w of methyl parahydroxybenzoate, 2% ethanol, 10% glycerol, distilled water twice a day (morning and evening) and each time 5 ml of the mouthwash for 30 seconds should be used.Gargle with betamethasone lotion four times a day (after meals and at bedtime) for one minute.
Category
Treatment - Drugs
2
Description
Control group: 0.2% chlorhexidine gluconate mouthwash and Iranian betamethasone lotion available on the market twice a day (morning and evening) and each time 5 ml of the mouthwash for 30 seconds should be used.Gargle with betamethasone lotion four times a day (after meals and at bedtime) for one minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry School of Kerman University of Medical Science
Full name of responsible person
Nahid Karbasi
Street address
Kerman,Islamic Republic Boulevard,End of Shafa Street,Kerman Dental School
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
sov.karbasi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
moluk torabi
Street address
Kerman,Islamic Republic Boulevard,End of Shafa Street,Kerman Dental School
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
sov.karbasi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Nahid Karbasi
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Kerman,Islamic Republic Boulevard,End of Shafa Street,Kerman Dental School
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
sov.karbasi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nahid Karbasi
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Kerman,Islamic Republic Boulevard,End of Shafa Street,Kerman Dental School
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
sov.karbasi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
nahid karbasi
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Kerman, Islamic Republic Blvd., End of Shafa St., Kerman School of Dentistry
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Fax
+98 34 3211 8073
Email
sov.karbasi@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD. IPD collected for primary outcome measure only.
When the data will become available and for how long
6 months after publication
To whom data/document is available
it will be available for people working in academic institutions.
Under which criteria data/document could be used
people working in academic institutions
From where data/document is obtainable
sov.karbasi@gmail.com dr.nahid.karbasi
What processes are involved for a request to access data/document
request containing how the data will be used must be applied via email. citation in future publication is mandatory. data will be sent within 3 months.