2.10. Course of the study
caries, tooth
CARIES


Potential subjects were informed by the investigator about the nature, significance, and scope of the clinical trial according to the requirements described in the written subject information. Before study enrollment, the willingness of the subjects to properly follow the study protocol throughout the 18 months of the study was assessed. Subjects were enrolled as study participants only when they had given their written informed consent. Subjects had to meet all inclusion criteria and no exclusion criteria. Subjects disqualified due to untreated caries became eligible after restorative therapy.Once informed consent had been given, an initial examination took place that covered the following aspects:Screening subjects for study eligibility (inclusion and exclusion criteria).Collection of demographic data.Baseline data collection performed in the following sequence: PCR, DMFS, DIAGNOcam.After the analysis of the PCR record using a plaque-staining solution, a professional tooth cleaning was performed. The professional tooth cleaning was performed at visits 1 and 4 only, and there was no fluoride application after the cleaning.Finally, the study subjects received an electric toothbrush with three brushing heads (replaced every 2 months) and the allocated toothpaste (test or control) by a trained study nurse or dentist not involved in clinical study examinations.The proper use of the assigned electric toothbrush and the issued toothpaste were also instructed by this study nurse or a dentist not involved in the clinical study examinations.

One-hundred eighty-two days after the baseline visit, the PCR and DMFS were reassessed as described for the baseline visit. Subsequently, a study nurse or a dentist who has not involved in clinical study examinations handed out three new brushing heads for the electric toothbrush and a new supply of the assigned experimental toothpaste (test or control) for the next 182 days. Finally, subjects received a new appointment for visit 3.

Three hundred sixty-four days after the baseline visit, the procedure performed on Visit 2 was repeated, after which the subjects received a new appointment for Visit 4.

Five hundred forty-six days after the baseline visit, the following assessments were repeated: PCR, DMFS after professional cleaning, and DIAGNOcam as described from the baseline visit.An overview of the study course in detail is presented in Study flowchart.