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IRCT20190928044908N1 IRCT 2019-12-17 Shiraz University of Medical Sciences Effect of Chamomile and Miswak containing dentifrice on gingivitis Comparing the effect of Chamomile and Miswak containing dentifrice with Triclosan containing dentifrice in gingivitis patients 2019-10-06 anticipated 30 Complete https://irct.ir/trial/42564 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly divided into two groups based on randomized block randomization method. A random individual has been extracted based on this method from Sealedenvelope.com . We have 2 groups and 15 participants in each group being equal in size. Allocation concealment is achieved through sealed envelopes. After the baseline questionnaire is completed, eligible participants are assigned to one of the 2 study groups by opening the envelopes as they entered the study, Blinding description: This is a single blinded clinical trial. As the toothpaste is given to patients by healthcare providers, researcher does not know how individuals are assigned to the intervention and control groups. And data will be analyzed through coding. Principle investigator, data collectors and outcome assessors being one person is referred as researcher. As contents of both groups are listed on the toothpaste tube participants are not blinded. 3 Gingivitis. Intervention 1: Intervention group: Clean Key chamomile and Miswak containing dentifrice; made in Iran; Ahuradarou company.All toothpaste contents are listed on the toothpaste tube. Brush twice a day for four weeks using soft toothbrush and bass method as instructed by the researcher. Intervention 2: Control group: Vi-One gum protector Triclosan containing dentifrice; Made in Iran Rojin company..All toothpaste contents are listed on the toothpaste tube. Brush twice a day using soft toothbrush and bass method as instructed by the researcher. 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 There is no further information
public Zahra Emami
Shiraz dental school, Ghasrodasht Ave., Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 zahra_emami63@yahoo.com Shiraz University of Medical Sciences scientific Zahra Emami
Shiraz dental school, Ghasrdasht Ave., Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 zahra_emami63@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Gingivitis patient Patient must be from 18 to 70 year old At least 20 teeth without full crown restoration Bleeding on probing index must be at least 40% No intake of any particular medicine Patients have not taken antibiotics in the past 6 months Patients have not used mouthwash in the past 6 months No smoking No pregnancy 18 years 70 years Both Periodontitis and/or attachment loss Periodontal pocket depth more than 3mm Systemic disease like Diabetes or Cardiovascular disease K05.10 Chronic gingivitis, plaque induced Treatment - Drugs Treatment - Drugs Intervention group: Clean Key chamomile and Miswak containing dentifrice; made in Iran; Ahuradarou company.All toothpaste contents are listed on the toothpaste tube. Brush twice a day for four weeks using soft toothbrush and bass method as instructed by the researcher. Control group: Vi-One gum protector Triclosan containing dentifrice; Made in Iran Rojin company..All toothpaste contents are listed on the toothpaste tube. Brush twice a day using soft toothbrush and bass method as instructed by the researcher The rate of periodontal pocket depth. Timepoint: Before intervention and after 2 and 4 weeks after intervention. Method of measurement: Periodontal probe. The rate of bleeding on probing. Timepoint: Before intervention and 2, 4 weeks after intervention. Method of measurement: Periodontal probe. The rate of dental plaque. Timepoint: Before intervention and 2, 4 weeks after intervention. Method of measurement: Disclosing agent. Shiraz University of Medical Sciences Approved 2019-09-08 Ethics committee of Shiraz University of Medical Sciences Shiraz dental school, Ghasrodasht Ave.,Shiraz Shiraz Fars Iran (Islamic Republic of)