Study design and allocation
calculus, ): Radio‐Frequency + Vibration
RECRUITMENT, GROUP B
This is a prospective, double‐blind, randomized, sham‐controlled two‐arm study of a 3‐month duration. Data is reported according to the Consolidated Standards of Reporting (CONSORT) guidelines. One experienced investigator (J.K.) evaluated the subjects and was responsible for the patients' enrollment process following the assessment of the inclusion and exclusion criteria. The study flow chart is reported in Figure Study flow‐chart.All brushes came with serial numbers (1–60) and were given to the participants by order of recruitment. The toothbrushes were pre‐divided to Group A or B via Research Randomizer as a way to generate random numbers, or in this case, assign the numbers to Groups A or B in a random way. This was done before the study began clinically. Thus, the patients were recruited and given a toothbrush in numerical ascending order, and consequently allocated to Group A or B according to the randomizer. Throughout the study and the analysis of the results, neither the investigators nor the research coordinator knew that Group A was the test and Group B was a sham. The test and sham group were revealed to us after the statistical analysis was performed.Group A (Test): Radio‐Frequency + Vibration. The patients in this group received a treatment of calculus removal using an ultrasonic device and manual curettes. Oral hygiene instructions were given by the same operator (J.K.) and the use of the toothbrush was demonstrated on a plastic model. The brushing technique instructed was modified bass; a 45° tilt of the bristles into the sulcus, a horizontal scrub of two to three teeth, and finally a sweep in an apico‐coronal direction. The brushing time instructed was a minimum of 2 min, while three vibration strengths were optional. At the end of the meeting, the patients received a vibrating electric toothbrush with active RF technology.Group B (Control): Vibration. The patients in this group received a treatment of calculus removal using an ultrasonic device and manual curettes. The same oral hygiene instructions were given, and the use of the toothbrush was demonstrated on a plastic model. At the end of the meeting, the patients received a vibrating electric toothbrush without RF technology.The toothbrushes were identical in shape, size, and vibration. The RF sign was illuminated in both groups to prevent exposure to group allocation but was only activated in the test group.