Evaluation of the Effectiveness of Bamboo Salt mouthwash compared to Non-Steroidal mouthwash in the improvement of Recurrent Aphthous Ulcers,a Double Blind Randomized Clinical Trial
Determining and comparing the healing indices of recurrent minor aphthous ulcers using bamboo salt mouthwash and non-steroidal benzydamine mouthwashes.
Design
A randomized, blinded, sham controlled clinical trial with a parallel group design of 40 patients, Randomisation was centralised using Block Randomization method
Settings and conduct
20 individuals randomly received the bamboo salt mouthwash and benzydamine and the other 20 received benzydamine and normal saline. After receiving instructions, the patients are asked to record the aphthous pain level on days 0, 1, 3, and 5 based on visual analogue scale (VAS) using a number from 0 to10. Moreover, they are informed to record the date of pain elimination and pseudomembrane removing. The time when the pseudomembrane and the erythematous border are removed is regarded as the complete healing date. During the treatment, researchers are constantly in contact with the patients to ensure they are following the instructions, recording the results correctly, and determining any adverse reactions.
After 1 week, the patients will examined again and the questionnaires are collected. At the end of the study the bottles will decoded.
The patients and researcher are blinded in this study.
Participants/Inclusion and exclusion criteria
Patients with minor aphthous lesions less than 2 days from initiation.
The individuals who had not suffered from systemic diseases or immunologic disease.
Patients who have not been receiving Anti-inflammatory, Antibiotics, sedative or immunosuppressive drugs for at least 2 weeks before the study begins
Intervention groups
The experimental group receives Benzydamine mouthwash and Bamboo salt mouthwash.
The control group receives Benzydamine mouthwash and Normal saline.
Main outcome variables
Duration of pseudomembrane removing; The size; The degree of pain of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160126026209N3
Registration date:2023-04-15, 1402/01/26
Registration timing:registered_while_recruiting
Last update:2023-04-15, 1402/01/26
Update count:0
Registration date
2023-04-15, 1402/01/26
Registrant information
Name
zahra saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5514
Email address
zahra.saberi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-08, 1402/01/19
Expected recruitment end date
2023-06-13, 1402/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Bamboo Salt mouthwash compared to Non-Steroidal mouthwash in the improvement of Recurrent Aphthous Ulcers,a Double Blind Randomized Clinical Trial
Public title
Evaluation of the effectiveness of Bamboo Salt mouthwash in the improvement of Recurrent Aphthous Ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with minor aphthous lesions less than 2 days from initiation
The individuals who had not suffered from systemic diseases or immunologic disease
The patient should not receive other concurrent medication for aphthous ulcers either systematically or locally at the same time with this medicine
Patients who had a history of frequent recurrence of aphthous lesions
The occurrence of aphthous lesions is not caused by beta blockers and NSAIDs
Patients who dose not being in pregnancy or breastfeeding time
Patients who have not been receiving Anti-inflammatory or immunosuppressive drugs for at least 2 weeks before the study begins
Patients who have not been receiving systemic Antibiotics for at least 2 weeks before the study begins
Have not treated aphthous ulcers with any other medicine in the last 3 days
Patients who have not been receiving sedative medicine for other diseases
Exclusion criteria:
In case of sudden problem or violation of Inclusion criteria, the patient will be excluded from the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly assigned(using Block Randomization method using Quadruple Blocks) into experimental and placebo groups (20 patients per each group). The products were placed in exactly similar containers and were coded by a third person, so that 20 individuals randomly received the Bamboo Salt mouthwash and Benzydamine and the other 20 received Benzydamine and Normal saline.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and researcher are blinded in this study. Participants are informed that they will randomly receive Benzydamine and Bamboo Salt mouthwash or Benzydamine and Normal saline. The products (Bamboo Salt mouthwash and Normal saline) were placed in exactly similar containers and were coded by a third person؛ so that the researcher and the participant are not aware of the received medicine received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
No.1,102 Alley., Amirkabir Ave
City
Khomeinishahr
Province
Isfehan
Postal code
8417643471
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.348
Health conditions studied
1
Description of health condition studied
recurrent aphthous ulcers
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Duration of lesion's pseudomembrane removing
Timepoint
The time when the pseudomembrane and the erythematous border are removed
Method of measurement
Observing the lesion
2
Description
The size of the lesion
Timepoint
The aphthous lesion size will be recorded on days 0, 1, 3, and 5
Method of measurement
Periodontal probe
3
Description
The aphthous pain level
Timepoint
The patients are asked to record the aphthous pain level on days 0, 1, 3, and 5
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gargle 60 cc (containing 30 cc of 10% bamboo salt and 30 cc of benzydamine 0.15%) solution every 8 hours and avoid eating and drinking for at least 30 to 60 minutes after use.
Category
Treatment - Drugs
2
Description
Control group: Gargle 60 cc (containing 30 cc normal saline 0.9% and 30 cc of benzydamine 0.15%) solution every 8 hours and avoid eating and drinking for at least 30 to 60 minutes after use.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental School
Full name of responsible person
Dr.Zahra Saberi
Street address
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
zahra.saberi@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Askari
Street address
Research and Technology Vice Chancellor, Building No. 4, Isfahan Unuversity of Medical Sciences School, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Zahra Saberi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8417643471
Phone
+98 31 3792 5514
Fax
Email
zahra.saberi@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Zahra Saberi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8417643471
Phone
+98 31 3792 5514
Fax
Email
zahra.saberi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Zahra Saberi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8417643471
Phone
+98 31 3792 5514
Fax
Email
zahra.saberi@dnt.mui.ac.ir
Web page address
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Questionnaires and information recorded by the researcher can be published
When the data will become available and for how long
The access period starts 6 months after the results are published