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IRCT20210906052393N1 IRCT 2021-10-25 Babol University of Medical Sciences Evaluation the effect of mouthwash containing propolis nanoparticles on the gum and teeth condition of orthodontic patients Evaluation the effect of mouthwash containing propolis nanoparticles on plaque and gingival indices in fixed orthodontic patients. 2021-12-04 anticipated 60 Complete https://irct.ir/trial/58568 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: People are divided into two groups of 30 people, so that in each group there will be 15 girls and 15 boys. The site kitset.ir is used to randomize the samples. In the Kitset site, from the number toolbox, select the option to generate random numbers. Then we request the production of 30 pieces from 1 to 30 in a non-sequential and non-repetitive way. The series of random numbers generated in the result box will be considered as the case number of the referring boy, the first 15 numbers will be in the case group and the next 15 numbers will be in the control group. We do the same for the referral girls again; In this way, we request the production of 30 pieces from 1 to 30 again without order and without repetition. The series of random numbers generated in the result box will be considered as the case number of the referring girl, the first 15 numbers will be in the case group and the next 15 numbers will be in the control group, Blinding description: Both types of mouthwashes are packaged with the same appearance so that the patient and the researcher do not know the type of solution in the container; One type of mouthwash will belong to group A and the other to group B‌. 3 Condition 1: Plaque index. Condition 2: Gingival index. Intervention 1: Intervention group: Use of three bottles containing 250 ml mouthwash containing propolis nanoparticles prepared in the Department of Pharmacology at Babol University of Medical Sciences. Patients in this group rinse their mouth with this solution twice a day (Each time with 15 ml of pure mouthwash) after tooth brushing, for one minute and should do so for 21 consecutive days. Intervention 2: Control group: Use of three bottles containing 250 ml mouthwash containing propolis particles prepared in the Department of Pharmacology at Babol University of Medical Sciences. Patients in this group rinse their mouth with this solution twice a day (Each time with 15 ml of pure mouthwash) after tooth brushing, for one minute and should do so for 21 consecutive days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Valiolah Arash
Ganjafrooz Ave.
Babol Iran (Islamic Republic of) 4717647745 +98 11 3220 7918 Vali-arash1344@yahoo.com Babol University of Medical Sciences scientific Valioalah Arash
Ganjafrooz Ave.
Babol Iran (Islamic Republic of) 4717647745 +98 11 3220 7918 Vali-arash1344@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Age range 13-19 years Having proper oral hygiene (Plaque Index ≤2 و Gingival Index≤ 2 the way of Sillness and Loe و Loe and Sillness ) Complete and informed patient satisfaction 13 years 19 years Both Existence of any systemic disease Pregnancy and lactation Smoking and alcohol consumption Existence of periodontal disease Having severe gingivitis and plaque accumulation History of any allergies to propolis or honey derivatives History of antibiotic consumption from two weeks before the intervention History of using any type of mouthwash during the month before the intervention Prevention Prevention Intervention group: Use of three bottles containing 250 ml mouthwash containing propolis nanoparticles prepared in the Department of Pharmacology at Babol University of Medical Sciences. Patients in this group rinse their mouth with this solution twice a day (Each time with 15 ml of pure mouthwash) after tooth brushing, for one minute and should do so for 21 consecutive days. Control group: Use of three bottles containing 250 ml mouthwash containing propolis particles prepared in the Department of Pharmacology at Babol University of Medical Sciences. Patients in this group rinse their mouth with this solution twice a day (Each time with 15 ml of pure mouthwash) after tooth brushing, for one minute and should do so for 21 consecutive days. Plaque Index in Ramford teeth of fixed orthodontic patients. Timepoint: Before the intervention and one week after brushing and 21 days after starting to use mouthwash containing propolis nanoparticles. Method of measurement: Standardized periodontal probe. Gingival Index in Ramford teeth of fixed orthodontic patients. Timepoint: Before the intervention and one week after brushing and 21 days after starting to use mouthwash containing propolis nanoparticles. Method of measurement: Standardized periodontal probe. Babol University of Medical Sciences Approved 2021-10-06 Ethics committee of Babol university of medical science Ganjafrooz Ave. Babol Mazandaran Iran (Islamic Republic of)