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IRCT20181121041713N2 IRCT 2019-12-24 Shiraz University of Medical Sciences Effects of L-arginine toothpaste in orthodontic patients 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 2019-08-23 anticipated 72 Complete https://irct.ir/trial/42409 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization, 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. N/A Amount of streptococcus mutans in dental biofilm. Intervention 1: Intervention group: patients will be asked to brush their teeth twice a day with toothpaste containing 8% arginine. Intervention 2: Control group: : Patients will be asked to brush their teeth twice a day with fluoride toothpaste. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is undecided
public Neda Babanouri
School of Dentistry, Qom Abad, Ghasrodasht St.
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3628 0801 nedababanouri@yahoo.com Shiraz University of Medical Sciences scientific Neda Babanouri
School of Dentistry, Qom Abad, Ghasrodasht St.
Shiraz Iran (Islamic Republic of) 7195615878 009836280801 nedababanouri@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 15 years 30 years Both 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 Prevention Prevention Intervention group: patients will be asked to brush their teeth twice a day with toothpaste containing 8% arginine. Control group: : Patients will be asked to brush their teeth twice a day with fluoride toothpaste 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. Shiraz University of Medical Sciences Approved 2019-08-23 Ethics committee of Shiraz University of Medical Sciences School of Dentistry, Qom Abad, Ghasrodasht St. Shiraz Fars Iran (Islamic Republic of)