This study aims to compare the antibacterial effects of Protact herbal mouthwash and chlorhexidine on Streptococcus mutans in orthodontic patients.
Design
A randomized clinical trial in the form of a randomized block with a control group, with parallel groups, double-blind on 22 patients. Choosing the type of group for each person through random allocation software 2
Settings and conduct
The study population will be patients who are candidates for fixed orthodontic treatment, referring to a private practice in Sari city, and the study site will be the Faculty of Dentistry of Mazandaran University of Medical Sciences. Sampling of patients of each group in 3 times; Mouthwash will be used before the intervention, immediately after the intervention and after 20 days of continuous use.
Participants/Inclusion and exclusion criteria
The study population will be selected from patients who are candidates for fixed orthodontic treatment referred to a private office in Sari city, who meet the entry criteria and do not meet the exit criteria of the study, during the years 1400-1401. The entry criteria will include patients without periodontitis and with proper cooperation (15 years and above). Exclusion criteria include poor patient cooperation, use of corticosteroids, sensitivity to mouthwash, or use of any antibiotic and mouthwash during the past three months for 10 consecutive days.
Intervention groups
Patients will be placed in two intervention (protact mouthwash) and control (0.2% chlorhexidine mouthwash) groups. Patients of both groups will be required to use 5 ml of their mouthwash twice a day (morning and night) for 20 days for 30 seconds to one minute and refrain from eating and drinking for an hour afterwards.
Main outcome variables
The number of Streptococcus mutans bacteria present on the elastic rings of the patients will be recorded at each stage of sampling and the data will be compared
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170502033770N3
Registration date:2023-06-20, 1402/03/30
Registration timing:registered_while_recruiting
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Hodis Ehsani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 4135
Email address
hehsani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-17, 1402/03/27
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of protact mouthwash with chlorhexidine on Streptococcus mutans attached to orthodontic elastic rings
Public title
The comparison of the effects of protact mouthwash with chlorhexidine on Streptococcus in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients without periodontitis
Patients with appropriate cooperation
Patients with a minimum age of 15 years
Exclusion criteria:
Patients using any antibiotics and mouthwash during the last three months for 10 consecutive days
Patients taking corticosteroids
Patients with mouthwash allergy
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
3
Sampling of each person will be done in three stages. Once before using the mouthwash, the second time after using the desired mouthwash and in the same session, the third sampling will be done after 20 days of consecutive use of the mouthwash.
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to assign samples to groups (type of mouthwash). First, the samples will be matched in terms of age, gender, periodontium condition and oral hygiene and people with similar status will be placed in a block. According to the total number of required samples (22 samples) and the number of mouthwashes, finally 11 blocks with matched samples will be considered as 2 samples in each block (number of mouthwashes). Selection of blocks and type of mouthwash for each sample will be done through random allocation software 2 and the samples will be placed in one of the groups by this software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. In order to blind patients, therapists and researchers, mouthwashes are placed in dark-colored bottles with the same appearance with different labels and according to the recommendations of the manufacturers, the mouthwash instructions leaflet is given to the patients in identical envelopes with different labels according to the mouthwash label, and the patients are asked to use the relevant mouthwash according to the leaflet.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Khazar Blvd, Sari Faculty of Dentistry (Tooba dental clinic)
City
Sari
Province
Mazandaran
Postal code
4816895475
Approval date
2022-07-06, 1401/04/15
Ethics committee reference number
IR.MAZUMS.REC.1401.229
Health conditions studied
1
Description of health condition studied
Dental caries and gingivitis caused by Streptococcus mutans bacterial plaques
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The number of Streptococcus mutans bacteria
Timepoint
in three occasions, before consumption, immediately after consumption and after 20 consecutive days of consumption
Method of measurement
Separation and collection of elastic rings
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will be given Protact mouthwash (Daneshgar Zolang Respina pharmaceutical company) and the patients will be required to use 5 ml of their mouthwash for 30 seconds to one minute twice a day (morning and night) for 20 days. and avoid eating and drinking for an hour after that. All patients will be given the same Oral_B toothbrush and toothpaste, and they will be taught proper mechanical hygiene (at least twice a day).
Category
Treatment - Drugs
2
Description
Control group: The control group will be given 0.2% chlorhexidine mouthwash (Iran Najo Pharmaceutical Company) and the patients will be required to use 5 ml of their mouthwash for 30 seconds to one minute twice a day (morning and night) for 20 days. and avoid eating and drinking for an hour after that. All patients will be given the same Oral_B toothbrush and toothpaste, and they will be taught proper mechanical hygiene (at least twice a day).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Faculty of Dentistry
Full name of responsible person
Hodis Ehsani
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Azam Haddadi Kohsar
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
haddadi_azam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hodis Ehsani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hodis Ehsani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hodis Ehsani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Sari Faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
hehsani@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
After the completion of the project, the results will be delivered in the form of a final report and in electronic form (on a CD) to the Vice-Chancellor of Research and Faculty of Dentistry of Mazandaran University of Medical Sciences.
When the data will become available and for how long
The decision regarding access to the data will be the responsibility of the vice president of research and the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor.
To whom data/document is available
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also the supervisor
Under which criteria data/document could be used
The request should be sent to the responsible person after consultation with the research team, the data will be provided to the requesting person, and it is necessary to give reference to the data owners in the articles or wherever the data is to be used, and the use of the results only It is allowed by citing its source.
From where data/document is obtainable
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also the supervisor
What processes are involved for a request to access data/document
A written request to the vice president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences and also obtaining the consent of the supervisor.