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IRCT20210414050964N1 IRCT 2021-06-21 Shahid Beheshti University of Medical Sciences Antimicrobial and anti plaque efficacy of herbal toothpaste containing Bamboo salt Clinical Evaluation of anti plaque and antimicrobial efficacy of bamboo salt toothpaste by culturing of Streptococcus mutans and Lactobacilli and plaque index evaluation 2021-06-21 anticipated 60 Complete https://irct.ir/trial/55649 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random Assignment The participants by use of random number table were randomly assigned into the control and case groups In this method, at first, in order to read the numbers( e.g. up, down, right, and left), the even numbers are considered for the case group, while the odd numbers are consider for the control group, Blinding description: Considerg the same mint flavour of the two toothpaste, information labels on all toothpaste tubes will be removed and their packages will be all designed similarly, in order to ensure the blinding of participants to the contents of toothpaste tubes. Colony counting will be also performed by a blind microbiologist (by coding the saliva samples, A as control group and B as case group). 3 anti plaque and antimicrobial efficacy. Intervention 1: Intervention group: The bamboo salt toothpaste (Tiger Herb®, LG, Korea), The Tiger Herb contains Hydrated Silica, Sodium Chloride (Bamboo Salt), Dipotassium Glycyrrhizinate, Sodium Fluoride, Sorbitol Solution (70%), Cellulose Gum, Sodium Saccharin, Sodium Lauryl Sulfate, Sodium Bisulfate, Blue 1 (E142090), Yellow 10 (47005) Flavor, mint extract and Water. All participants will be instructed to brush their teeth with a medium bristled brush (Oral-B, Ireland) by using 1 centimeter toothpaste for two minutes using the Bass technique twice a day (after breakfast and before bedtime) for four weeks. They will be also instructed to use non-fluoridated dental floss (Oral B, Ireland) every night before going to bed, and refrain from using other fluoride-containing products. Saliva sampling pluque index will be performed at baseline and after four weeks of toothpaste use. Intervention 2: Control group: Crest® Complete toothpaste (Procter & Gamble Plaza, Cincinnati, OH 45202, United States) The Crest Complete toothpaste contains Aqua, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, mint extract, Aroma, Zinc Citrate, Chondrus Crispus Powder, Sodium Fluoride (1450 ppm), Sodium Saccharin, Hydroxyl Ethylcellulose, Cl 77891, Sodium Citrate, Stannous Chloride, Silica, Glycerin and Cl 74160. All participants will be instructed to brush their teeth with a medium bristled brush (Oral-B, Ireland) by using 1 centimeter toothpaste for two minutes using the Bass technique twice a day (after breakfast and before bedtime) for four weeks. They will be also instructed to use non-fluoridated dental floss (Oral B, Ireland) every night before going to bed, and refrain from using other fluoride-containing products. Saliva sampling pluque index will be performed at baseline and after four weeks of toothpaste use. No - There is not a plan to make this available Justification or reason for not sharing IPD is participants Privacy
public Mina Bira
Velenjak St., Shahid Chamran Highway
تهران Iran (Islamic Republic of) 1983963113 +98 21 2670 8362 drbiriam@gmail.com Shahid Beheshti University of Medical Sciences scientific Mina Biria
Velenjak St., Shahid Chamran Highway
تهران Iran (Islamic Republic of) 1983963113 +98 21 2670 8362 drbiriam@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Without periodontal pocket depth of more than three millimeters Without history of smoking and dry mouth Without using of orthodontic appliances Without presence of untreated dental caries Without history of systemic diseases routine daily toothbrushing with fluoride-containing toothpastes Without receiving antibiotic or anti-inflammatory drugs at least one month prior to the study Without allergic reaction to the toothpaste 18 years 24 years Both Pregnant Lactating women History of using other herbal drugs at least one month prior the study Prevention Prevention Intervention group: The bamboo salt toothpaste (Tiger Herb®, LG, Korea), The Tiger Herb contains Hydrated Silica, Sodium Chloride (Bamboo Salt), Dipotassium Glycyrrhizinate, Sodium Fluoride, Sorbitol Solution (70%), Cellulose Gum, Sodium Saccharin, Sodium Lauryl Sulfate, Sodium Bisulfate, Blue 1 (E142090), Yellow 10 (47005) Flavor, mint extract and Water. All participants will be instructed to brush their teeth with a medium bristled brush (Oral-B, Ireland) by using 1 centimeter toothpaste for two minutes using the Bass technique twice a day (after breakfast and before bedtime) for four weeks. They will be also instructed to use non-fluoridated dental floss (Oral B, Ireland) every night before going to bed, and refrain from using other fluoride-containing products. Saliva sampling pluque index will be performed at baseline and after four weeks of toothpaste use Control group: Crest® Complete toothpaste (Procter & Gamble Plaza, Cincinnati, OH 45202, United States) The Crest Complete toothpaste contains Aqua, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, mint extract, Aroma, Zinc Citrate, Chondrus Crispus Powder, Sodium Fluoride (1450 ppm), Sodium Saccharin, Hydroxyl Ethylcellulose, Cl 77891, Sodium Citrate, Stannous Chloride, Silica, Glycerin and Cl 74160. All participants will be instructed to brush their teeth with a medium bristled brush (Oral-B, Ireland) by using 1 centimeter toothpaste for two minutes using the Bass technique twice a day (after breakfast and before bedtime) for four weeks. They will be also instructed to use non-fluoridated dental floss (Oral B, Ireland) every night before going to bed, and refrain from using other fluoride-containing products. Saliva sampling pluque index will be performed at baseline and after four weeks of toothpaste use Plaque index. Timepoint: At baseline and after four weeks of toothpaste use. Method of measurement: plaque indicator. Lactobacillus. Timepoint: At baseline and after four weeks of toothpaste use. Method of measurement: cultivating and count bacteria. Streptococcus mutans. Timepoint: At baseline and after four weeks of toothpaste use. Method of measurement: cultivating and count bacteria. Shahid Beheshti University of Medical Sciences Approved 2020-08-24 institutional ethics committee of biomedical research of dental science's institue Velenjak St.,Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)