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

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

A clinical trial with parallel intervention groups, double-blind, randomized, phase two on 165 patients. The sampling method is random. Randomization using a table of random numbers is the Random Allocation Software.

Among the children aged 6-12 years referring to Tabriz Dental Faculty, they participated in the study. All people will be trained in oral hygiene and the plaque index will be calculated. Patients are randomly assigned to one of the groups. In the first intervention group, 20 ppm ozone gel and in the second intervention group, 1% chlorhexidine gel are applied twice a day (morning and night) half an hour after meals for 3 weeks using a finger on all dental surfaces. In the third group, People will rub their clean finger on all tooth surfaces. After three weeks, the final plaque index will be calculated. The patient is aware of the existence of several types of treatment but does not know which group he is in. The evaluators of the plaque index are not aware of the type of intervention.

Inclusion criteria: Have not been treated with antibiotics in the last 3 weeks. People with high caries risk (dmft above 3) Exclusion criteria: Unwillingness to cooperate in the sampling process at the specified time, Appearance of allergy symptoms to the substances used in the study, Failure to follow the instructions given

Intervention 1: Ozonated gel 20 ppm - Intervention 2: Chlorhexidine gel 1% - Control: No use of gel

The plaque index Number of Streptococcus mutans bacteria

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.

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).