Evaluation of clinical efficacy of an Iranian-made toothbrush in fixed orthodontic patients (Randomized clinical trial)

Determining the clinical efficacy of Confident toothbrush among fixed orthodontic patients

Clinical trial, Cross over, Double blind, Randomized, Phase 3 on 40 patients, The rand function of the Excel software was used for randomization.

Two groups of 20 patients undergoing fixed orthodontic treatment are randomly selected. Plaque index (PI) , Gingival index(GI) and Ortho-plaque index(OPI) are measured for them at time T0. Patients are taught by a clinician how to brush.The first group uses an Iranian-made toothbrush (Confident), and the second group uses a common foreign brand (Oral B), and after one month (T1), all three indexes are measured. One-week washout period is located between two phase of the study and after one week at T2 all three indexes are measured again. The members of the two groups exchange, and finally, after a month, the indexes are measured at T3. The average of the indexes for patients in groups 1 and 2 is calculated at T0, T1, T2 and T3. Thus the clinical efficiency of this toothbrush is evaluated.

Patients are at the end of the first phase of treatment. Patients have a fixed orthodontic appliance for at least one month. Lack of lingual arch in the lower jaw and transpalatal arch or Nance in the upper jaw and any auxillary appliance.

Patients in intervention group are asked to use Confident toothbrush and patients in control group are asked to use Oral B toothbrush for one month. Its efficacy is measured by comparing using Plaque index, Gingival index and Ortho-plaque index.

Plaque index (Silness & Loe): Microbial plaque thickness in the gingival area of ​​the tooth to assess patient plaque control function. Gingival index (Silness & Loe): to assess the severity of gingivitis. Ortho-plaque index: Plaque index for fixed orthodontic patients.

Randomization is done by Balanced block randomization. To randomize the samples, they are numbered in order of entry into the study, Randomization is done using 4 random blocks.Due to the fact that there are 2 different modes of 2 types of intervention, in each block 2 samples are assigned to each of the following states: 1. First Oral B then Confident 2. First Confident then Oral B The placement of samples inside the blocks will be by Random allocation method, in such a way that there are 2 samples from each group in the block. Randomization is done using Excel software and This process is designed by the project methodological consultant who is not involved in the executive operation of the study.

Participant: The brand name of the toothbrush is covered. Care provider: The toothbrushes are distributed by another person and the person who measures indexes does not know how the participants are allocated in groups. Outcome assessor: The toothbrushes are distributed by another person and the person who gives patients information about oral hygiene and the method of brushing does not know how the participants are allocated in groups.