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.
A minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
Willingness to use an electric (powered) toothbrush
Willingness to use interdental floss
Willingness to have bitewing radiographs taken
Untreated caries [clinical investigation and analysis with an intraoral camera (DIAGNOcam)] (→ unsuitable subjects with one or two untreated caries in need of a restoration can become eligible after restorative therapy. If there are three or more untreated caries patients will be excluded)
Xerostomia (medication, radiation, disease induced)
Chemo/radiation therapy
Physical or mental disability which prevents proper oral health care
Parallel
2% Calcium Hypophosphite Toothpaste
DeviceOral 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).
Sodium Fluoride Toothpaste (1450 ppm F)
DeviceOral hygiene instruction and regular application of the Sodium Fluoride Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).
Evaluate 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).
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).
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
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Dr. Joachim Enax
Lead sponsor
Dr. Kurt Wolff GmbH & Co. KG
Sponsor institution
Department of Integrated Dentistry Medical University of Białystok
Collaborator
Poznan University of Medical Sciences, Department of Integrated Dentistry
Collaborator
