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IRCT20220727055562N1 IRCT 2022-08-15 Tabriz University of Medical Sciences The effect of the ozonated gel on children's dental plaque The effect of 20 ppm ozonated gel and 1 % chlorhexidine gel on plaque index and the number of Streptococcus mutans obtained from dental plaque in children aged 6-12 years: A double-blind randomized clinical trial study 2022-08-13 anticipated 165 Complete https://irct.ir/trial/65219 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random sampling will be done among the patients referred to Tabriz Dental Faculty who are eligible for the study. The randomization method is simple and its unit is individual. Our tool for randomizing a table of random numbers. Based on this, the type of treatment is marked with code A (20 ppm ozone gel), B (1% chlorhexidine gel), and C (control) and placed inside sealed envelopes. Then the envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. In order to avoid selection bias, the random assignment of people to the study groups will be concealed and will remain hidden until the interventions are carried out. None of the patients will be informed about the treatment of another patient, Blinding description: This study is double-blind. Patients are aware of the existence of some types of treatment, but they do not know which group they belong to. After preparation, the gels will be transferred to containers with the same shape and packaging and will be labeled, and only the code of the gels will be recorded on the label (blinding of the treatable people) and only one of the collaborators of the project will know the content of the gels and he knows how to allocate the patients in the groups, he will distribute the gels among the patients, and the examination and taking of plaque samples will be done by another colleague of the project who does not know the type of patient group (blinding of the treating people). 2 Dental caries. Intervention 1: The first intervention group: O3life 20 ppm ozonated gel is applied twice a day (morning and night) half an hour after meals for 3 weeks using a finger on all dental surfaces. After three weeks, the final plaque index and the number of Streptococcus mutans bacteria will be calculated. Intervention 2: The second intervention group: HEXIGEL 1% chlorhexidine gel is applied twice a day (morning and night) half an hour after meals for 3 weeks using a finger on all dental surfaces. After three weeks, the final plaque index and the number of Streptococcus mutans bacteria will be counted. Intervention 3: Control group: The patient's clean finger is rubbed twice a day (morning and night) half an hour after meals for 3 weeks on all dental surfaces. After three weeks, the final plaque index and the number of Streptococcus mutans bacteria will be calculated. 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 Ziya Ebrahim Adhami
Golgasht St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 adhamipedodontist@gmail.com Tabriz University of Medical Sciences scientific Ziya Ebrahim Adhami
Golgasht St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 adhamipedodontist@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 6 to 12 years Being healthy in the state of systemic condition No known allergies Consent to participate in the study 6 years 12 years Both History of allergy to chlorhexidine or ozone Antibiotic use in the past few months Children with mental and physical disabilities History of frequent food and drug allergies K02 Dental caries Treatment - Drugs Treatment - Drugs Other The first intervention group: O3life 20 ppm ozonated gel is applied twice a day (morning and night) half an hour after meals for 3 weeks using a finger on all dental surfaces. After three weeks, the final plaque index and the number of Streptococcus mutans bacteria will be calculated. The second intervention group: HEXIGEL 1% chlorhexidine gel is applied twice a day (morning and night) half an hour after meals for 3 weeks using a finger on all dental surfaces. After three weeks, the final plaque index and the number of Streptococcus mutans bacteria will be counted. Control group: The patient's clean finger is rubbed twice a day (morning and night) half an hour after meals for 3 weeks on all dental surfaces. After three weeks, the final plaque index and the number of Streptococcus mutans bacteria will be calculated. Plaque index. Timepoint: Once before the start of the intervention and the second time after three weeks (at the end of the intervention). Method of measurement: After people use the detector tablet, the amount of plaque index is calculated and recorded. Number of Streptococcus mutans bacteria. Timepoint: Once before the start of the intervention and the second time after three weeks (at the end of the intervention). Method of measurement: The dental plaque sample will be removed from all surfaces of the desired tooth using a sterile toothpick and will be transferred to the microbiology laboratory and cultured in the Agar medium. The number of bacterial colonies is counted. Tabriz University of Medical Sciences Approved 2022-06-27 Ethics Committee of Tabriz University of Medical Sciences Golgasht St., Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)