Protocol summary

Study aim
Determining the effect of combined herbal mouthwash (containing Thymus, Aloe vera, Glycyrrizha and Myrtus ) on oral aphthous lesions
Design
A clinical trial with a control group (with three groups), with parallel groups, three blinded, randomized, phase 3 on 90 patients (each group 30 patients). A table of random numbers is used for randomization.
Settings and conduct
In this study, 90 patients with minor oral aphthous lesions (within the first 48 hours of the onset of the lesion) who referred to the oral diseases department of Qazvin Dental Faculty, after receiving informed consent are randomly entered into one of the three study groups. Completely identical and coded containers are randomly given to patients by the department secretary, the evaluator and the patient are unaware of the mouthwash content. The size of the lesions is recorded by the periodontal probe and the pain of the patients using the VAS scale in the same meeting. On the third, fifth, and seventh days, the patient returns, and the size of the lesions and pain are measured. Patients are told to rinse their mouth with 10 ml of mouthwash for 1 minute 3 times a day after each meal until the lesion disappears and to avoid eating and drinking for 30 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with minor oral aphthous lesions, less than 48 hours have passed since the lesion. Exclusion criteria: Patients who are allergic to medicinal plants or have systemic diseases (High blood pressure, Diabetes, Hyperlipidemia, Behcet's disease, Rheumatic disease).
Intervention groups
The first group: receive combined herbal mouthwash (containing Thymus, Aloe vera, Glycyrrizha and Myrtus ) The second group: receive mouthwash containing triamcinolone. The third group (control): receive placebo mouthwash.
Main outcome variables
1) Size of lesion 2) Pain level 3) Healing duration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220522054957N1
Registration date: 2022-08-24, 1401/06/02
Registration timing: prospective

Last update: 2022-08-24, 1401/06/02
Update count: 0
Registration date
2022-08-24, 1401/06/02
Registrant information
Name
Benyamin Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3334 4569
Email address
benyaminkazemi1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-11, 1401/06/20
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Combined Herbal Mouthwash (Containing Thymus, Aloe vera, Glycyrrizha and Myrtus ) on Oral Aphthous Lesions; A Triple-Blind Randomized Clinical Trial Study
Public title
The Effect of Combined Herbal Mouthwash (Containing Thymus, Aloe vera, Glycyrrizha and Myrtus ) on Oral Aphthous Lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Oral aphthous lesions less than 48 hours have passed since the lesion Oral aphthous lesions are of minor type The age of patients should be between 18 and 60 years
Exclusion criteria:
Having systemic diseases Drug use, smoking, alcohol and drug addiction Patient sensitivity to medicinal plants
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used with the help of a table of random numbers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, the evaluator (researcher) as well as the data analyst are not aware of the type of mouthwash received by the patient. Mouthwash containers have the same shape and color and are given to patients by another person.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
No. 9, Shahaamat Alley., Modarres Blvd
City
Qazvin
Province
Qazvin
Postal code
3413815164
Approval date
2022-08-12, 1401/05/21
Ethics committee reference number
IR.QUMS.REC.1401.130

Health conditions studied

1

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

Primary outcomes

1

Description
Pain level of oral aphthous lesions
Timepoint
Measuring the pain level of oral aphthous lesions at the beginning of the study (before the start of the intervention) and 3, 5 and 7 days after the start of using the mouthwash
Method of measurement
By the Visual Analogue Scale

2

Description
Size of oral aphthous lesions
Timepoint
Measuring the size of oral aphthous lesions at the beginning of the study (before the start of the intervention) and 3, 5 and 7 days after the start of using the mouthwash
Method of measurement
By periodontal probe

3

Description
Healing duration of oral aphthous lesions
Timepoint
Examining the healing of oral aphthous lesions after starting to use mouthwash, on days 3, 5 and 7 or more, until the day when the lesion is completely healed.
Method of measurement
Calendar

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: This group uses a combined herbal mouthwash containing Thymus, Aloe vera, Glycyrrizha and Myrtus with a concentration of 4%, which was prepared in the Biotechnology Laboratory of Qazvin University of Medical Sciences and formulated in Alborz Darou Company of Qazvin until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that.
Category
Treatment - Drugs

2

Description
The second intervention group: This group uses Triamcinolone mouthwash with a concentration of 0.1%, which is made in Alborz Darou Company of Qazvin, until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that.
Category
Treatment - Drugs

3

Description
Control group: This group uses placebo mouthwash until the aphthous lesion disappears. In this way, 3 times a day (after each meal), 10 ml of mouthwash is used for 1 minute and they avoid eating and drinking for 30 minutes after that.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Qazvin University of Medical Sciences
Full name of responsible person
Benyamin Kazemi
Street address
No. 9, Shahaamat Alley., Modarres Blvd
City
Qazvin
Province
Qazvin
Postal code
3413815164
Phone
+98 28 3334 4569
Email
benyaminkazemi1999@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyyed Mehdi Mirhashemi
Street address
No. 9, Shahaamat Alley., Modarres Blvd
City
Qazvin
Province
Qazvin
Postal code
3413815164
Phone
+98 28 3334 4569
Email
benyaminkazemi1999@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Benyamin Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, Shahaamat Alley., Modarres Blvd
City
Qazvin
Province
Qazvin
Postal code
3413815164
Phone
+98 28 3334 4569
Email
benyaminkazemi1999@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Benyamin Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, Shahaamat Alley., Modarres Blvd
City
Qazvin
Province
Qazvin
Postal code
3413815164
Phone
+98 28 3334 4569
Email
benyaminkazemi1999@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Benyamin Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, Shahaamat Alley., Modarres Blvd
City
Qazvin
Province
Qazvin
Postal code
3413815164
Phone
+98 28 3334 4569
Email
benyaminkazemi1999@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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