Randomization (random number generation, allocation concealment, implementation)
tooth
PLAQUE, PLAQUE
The patients were randomly assigned to one of the three treatment sequences determined by a computer-generated plan prepared before the study (ABC, BCA, and CAB) with 30 participants in each treatment sequence. Group allocation and distribution of toothbrushes was done by an investigator who was blinded to the data collection. Allocation concealment was achieved with sequentially numbered, opaque, sealed envelopes containing the treatment allocation cards, which were prepared before the trial.The participants were recalled four times (visit and scored 1, 2, 3, and 4) with a wash-out period of 1 week between each visit.As part of the study, the participants consented not to brush their teeth the day before each appointment and refrain from eating, drinking, and smoking for 4 h before each visit, except for small sips of water. Two evaluators who were blinded to the group allocation evaluated the plaque. The inter-examiner reliability test for the evaluation of the plaque score was conducted and calculated using the Intraclass correlation coefficient.The sample’s understanding of the brushing method was evaluated by the investigator before beginning the study. On Day 1, the patients were interviewed, and the relevant information was obtained regarding their demography, and regular oral hygiene behavior and they received a dental clinical examination that included recording the number of teeth present.On day 1, all the patients received oral and written instructions regarding the use of their assigned toothbrush with the Modified Bass method. The toothbrush is placed at the gum margin at an angle of 45° and making small, vibratory movements, also moving along the dental arches until all accessible tooth surfaces had been brushed. The tooth brushing was performed for 2 min (30 s for each quadrant) with the assigned toothbrush, using standard fluoride toothpaste in front of the examiner during each appointment. After brushing, the participants were instructed to lightly rinse their mouths once with water.During each visit, the plaque was recorded using a red disclosing solution to obtain the baseline data. Plaque assessments were performed by two periodontists who were blinded to the brushing method, using the Turesky Modified Quigley-Hein Plaque Index [The same procedure was done during subsequent appointments using the other toothbrushes that were randomly assigned to each participant. All three periods followed the same procedure. Participants' accountability was documented at Period 3.The criteria for plaque scoring using the Turesky Modified Quigley-Hein Plaque Index, were as follows [The buccal and lingual surfaces of each tooth were scored. A total of 40 surfaces on 20 teeth were scored per participant. The average values for each participant were calculated by dividing the total score by the number of teeth examined.