Hydroxyapatite-toothpaste and Enamel Caries in the Primary Dentition (ECIPDEN17)
Tooth Decay, Hydroxyapatite, Tooth Demineralization
About this trial
This is an interventional prevention trial for Tooth Decay focused on measuring Dental caries, Toothpaste, Fluoride, Hydroxyapatite
Eligibility Criteria
Inclusion Criteria:
- age 3-6 years
- complete set of fully erupted primary molars (teeth 55, 54, 64, 65, 75, 74, 84, 85)
- presence of a caries restoration (filling) on a minimum of 1 primary molar
- minimum of 4 primary molars without a restoration or fissure sealing
Exclusion Criteria:
- untreated caries lesions of ICDAS code 3-6
- known hypersensitivity to one of the ingredients of the toothpastes to be tested
- systemic disorders interfering with salivary function or flow
- regular medication intake interfering with salivary function or flow
- need for antibiotic prophylaxis during dental treatments
- participation in any other clinical study within the past 3 months or ongoing
- lack of intellectual or physical ability to conduct the study properly
- any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study
Sites / Locations
- Poznan University of Medical Sciences, Department of Integrated Dentistry
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tooth Brushing HAP+Restorative dentistry
Tooth Brushing F+Restorative dentistry
Arm Intervention: HA-Toothpaste Tooth Brushing HA Prophylactic cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated toothpaste containing microcrystalline hydroxylapatite 3x daily over the duration of the study (336 days). Procedure: Tooth Brushing HA
Cleaning teeth using a standardized electric tooth brush and a fluoridated tooth paste containing amino fluoride (500 ppm F-), (three times daily over the duration of the study (336 days). Intervention: Procedure: Tooth Brushing F 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated toothpaste.