The aim of the study is to compare the caries-preventive effect of the test and control toothpaste in order to proof the non-inferiority of the test toothpaste compared to the control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
164
Oral hygiene instruction and regular application of the 2% Calcium Hypophosphite Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).
Oral hygiene instruction and regular application of the Sodium Fluoride Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).
Department of Integrated Dentistry Medical University of Białystok
Bialystok, Poland, Poland
NOT_YET_RECRUITINGPoznan University of Medical Sciences, Department of Integrated Dentistry
Poznan, Poland, Poland
RECRUITINGEvaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index
Comparison between the 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects showing no increase in overall Decay-Missing-Filled index during the observation period of 546 days (assessed by the investigator).
Time frame: Day 1, Day 182±28, Day 365±28 vs. Day 546±28
Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of interproximal caries lesions
Comparison between 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects with no change in mineral density, as analyzed by DIAGNOcam Full Vision HD using near-infrared laser transillumination, over an observation period of 546 days (assessed by the investigator).
Time frame: Day 1 vs. Day 546±28
Evaluate the efficacy of 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of dental plaque deposition using the Plaque Control Record (PCR) index
At the study visits, a suitable disclosing solution such as Bismarck Brown, Diaplac or similar is painted on tooth surfaces. After the subject has rinsed, the investigator (using an explorer or a tip of a probe) examines each stained surface for soft accumulations at the dentogingival junction. After all teeth have been examined and scored, the index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces. Plaque Control Record Index Calculation = The number of plaque containing surfaces / The total number of available surfaces
Time frame: Day 1, Day 182±28, Day 365±28 vs. Day 546±28
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