Comparison of the effect of L-arginine toothpaste and fluoride toothpaste on Streptococcus mutans in orthodontic patients: PCR based-method,single center, triple blind randomized clinical trial
The aim of this study is to evaluate the effects of L-arginine toothpaste on streptococcus mutans in orthodontic patients.
Design
A single-center, concealed, randomized, triple blind clinical trial with the control group
Settings and conduct
72 Participants will be recruited from orthodontic patients attending the orthodontic clinic at the Dental faculty of Shiraz University of Medical Science Block randomization method will be used with block length = 6 to allocate patients to two study groups with a 1:1 ratio: ّfluoride toothpaste group (control) and L-arginine toothpaste group (experimental). All toothpaste will be spilled into identical tubes that will be color coded by, so the clinician who assigns the intervention, the patients, laboratory technician, and the statistician will be all blind to the treatment groups. Biofilm samples will be collected at 2 times: at the beginning of the study (T0) and after 30 days (T1). Polymerase chain reaction will be used to analyses the biofilm samples.
Participants/Inclusion and exclusion criteria
15-30 year-old patients with fixed orthodontic appliance, who have signed the informed consent form.
Intervention groups
1- Control group: Fluoride toothpaste twice a day
2- Experimental group 2: Arginine toothpaste twice a day
Main outcome variables
َAmount of streptococcus mutans in biofilm samples
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181121041713N2
Registration date:2019-12-24, 1398/10/03
Registration timing:retrospective
Last update:2019-12-24, 1398/10/03
Update count:0
Registration date
2019-12-24, 1398/10/03
Registrant information
Name
neda babanouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 0801
Email address
babanouri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of L-arginine toothpaste and fluoride toothpaste on Streptococcus mutans in orthodontic patients: PCR based-method,single center, triple blind randomized clinical trial
Public title
Effects of L-arginine toothpaste in orthodontic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female subjects
Age between 15 and 30 years
Permanent dentition
Good general health (no significant medical history or medication during the last month)
No anti-inflammatory or antibiotic medications taken in the month before the study
No chewing gum or mouthwash use in the last week and during the study
Habit of brushing twice daily with fluoride toothpaste
No open or untreated caries lesions or gingival inflammation
Exclusion criteria:
Diseases and medications that would be likely to affect dental biofilm
Poor oral hygiene,
Active periodontal disease
Sever crowding of anterior teeth or sever malposition of lateral incisor that would be likely to interfere with cleaning of tooth surface
Smoking
History of mouth breathing
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
All toothpaste will be spilled into identical tubes that will be color coded by the first investigator (NB), so the clinician who assigns the intervention, the patients, laboratory technician, and the statistician will be all blind to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
School of Dentistry, Qom Abad, Ghasrodasht St.
City
Shiraz
Province
Fars
Postal code
7195615878
Approval date
2019-08-23, 1398/06/01
Ethics committee reference number
IR.SUMS.DENTAl.REC.1398.58
Health conditions studied
1
Description of health condition studied
Amount of streptococcus mutans in dental biofilm
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of streptococcus mutans in dental biofilm
Timepoint
T0: at the beginning of the study, T1 after 30 days
Method of measurement
Real-time polymerase chain reaction will be used to analyses the biofilm samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will be asked to brush their teeth twice a day with toothpaste containing 8% arginine.
Category
Prevention
2
Description
Control group: : Patients will be asked to brush their teeth twice a day with fluoride toothpaste
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic Clinic of Shiraz Dental Faculty
Full name of responsible person
Dr. Mahtab Memarpour
Street address
School of Dentistry, Qom Abad, Ghasrodasht St.
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 0112
Email
nedababanouri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemy
Street address
6th Floor, Central building of Shiraz University of Medical Sciences Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Neda Babanouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Qom Abad, Ghasrodasht St.
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 0801
Email
nedababanouri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Babanouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Qom Abad, Ghasrodasht St.
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
009836280801
Email
nedababanouri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Babanouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Qom Abad, Ghasrodasht St.
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
009836280801
Email
nedababanouri@yahoo.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