Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)
Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
Dr. Joachim Enax
164 participants
Jan 22, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
- Willingness to undergo an oral examination by an intraoral camera (DIAGNOcam)
Exclusion Criteria11
- 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
- Orthodontic treatment
- Severe periodontitis at the Baseline Visit (pocket depth on at least one tooth ≥ 5.5 mm)
- Known hypersensitivity to one of the ingredients of the toothpastes to be tested
- Regular medication intake interfering with salivary function or flow
- Current pregnancy, the wish to become pregnant, the suspicion of being pregnant, or breastfeeding or in the course of the study
- or more carious lesions/restorations in last 36 months until Baseline Visit
- Teeth missing due to caries in last 36 months until Baseline Visit
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Interventions
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).
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07068204