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IRCT20191004044977N2 IRCT 2020-12-18 Yazd University of Medical Sciences Antimicrobial effect of two toothpastes in children Comparsion of the antimicrobial effect of two toothpastes on salivary streptococcus mutans and lactobacillus and candida albicans of plaque in children aged 4 to 6 years with Early Chilhdood Caries 2021-02-19 anticipated 26 Complete https://irct.ir/trial/52491 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization method is simple and individual using a list of random numbers that includes two groups A and B. In group A, patients are given aloe vera toothpaste in the first phase and in group B, in the first phase, fluoride toothpaste is given to patients. The listed numbers are written on the same paper and placed in the same envelope. The envelopes are opaque and do not have any mark or writing. All 26 envelopes are placed in a box, and after determining the adequacy of the sample to enter the study and obtain informed consent, the patient is asked to choose one of the envelopes in the box. The envelope is opened, the patient number and the type of intervention in the first phase are determined, Blinding description: Due to the uniform coverage of the toothpaste tubes, the patient is unaware of which treatment group she/he is in. Also, the microbiologist is unaware of which group the samples belong to. The statistics analyst is not aware of type of intervention for each patient. N/A Dental caries. Intervention 1: Intervention group: Use aloe vera toothpaste (Forever Living Product, Scottsdale, AZ, USA) for thirty days. Then the wash out period for 2 weeks and displacement of control and case groups . Intervention 2: Control group: Use fluoride toothpaste (2080; Aekyung Industrial, Seol, Korea) for thirty days. Then the wash out period for 2 weeks and displacement of control and case groups . Yes - There is a plan to make this available What will be shared: Undetectable information will be released, including age, sex and number of decayed teeth. The results of the study, including the number of bacterial and fungal colonies, will also be published. When: Starting 9 months after publication To whom: The data are only available for people working in academic institutions. Conditions: Use of this data is permitted for systematic review and meta-analysis . Similar clinical trials can also use to criticiza the present study and its results in their discussion. Where to obtain: Send an email to 1 : mrezaei2024@gmail.com 2: zbahrololoom@yahoo.com How to obtain: After the request via one of the two methods listed above, if the request matches the sharing information mentioned before, this information will be available to the applicant within one month. Comments:
public Maedeh Rezaei
Dentistry Faculty of Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Dahe fajr Ave.
Yazd Iran (Islamic Republic of) 8914815669 +98 35 3621 4257 mrezaei2024@gmail.com Yazd University of Medical Sciences scientific Maedeh Rezaei
Dentistry Faculty of Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Dahe fajr Ave.
Yazd Iran (Islamic Republic of) 8914815669 +98 35 3621 4257 mrezaei2024@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Children aged 4 to 6 years who have 2 to 3 decayed teeth Children without systemic disease Not receiving professional topical fluoride in the last 3 months Absence of any intraoral pathology Children who are positive or completely positive according to Frankel Behavior scale Consent of parents and patients to participate in the study 4 years 6 years Both Children who need emergency dental treatment Children undergoing orthodontic treatment or with intraoral prostheses Take antibiotics 3 months before treatment or during treatment K02.9 Dental caries, unspecified Treatment - Other Treatment - Other Intervention group: Use aloe vera toothpaste (Forever Living Product, Scottsdale, AZ, USA) for thirty days. Then the wash out period for 2 weeks and displacement of control and case groups . Control group: Use fluoride toothpaste (2080; Aekyung Industrial, Seol, Korea) for thirty days. Then the wash out period for 2 weeks and displacement of control and case groups . Salivary Streptococcus mutans. Timepoint: At the beginning of the study and 30 days later. Method of measurement: Counting the number of Streptococcus mutans colonies in MSA culture medium. Salivary lactobacillus. Timepoint: At the beginning of the study and 30 days later. Method of measurement: Counting the number of lactobacillus colonies in MRS culture medium. Candida Albicans plaque. Timepoint: At the beginning of the study and 30 days later. Method of measurement: Counting the number of Candida albicans colonies in Sabouraud dextrose agar culture medium. Yazd University of Medical Sciences Approved 2020-07-28 Ethics committee of Shahid Sadoughi University of Medical Sciences یزد Central Building of Shahid Sadoughi University of Medical Sciences, ‌‌Bahonar Square Yazd Yazd Iran (Islamic Republic of)