2% Calcium Hypophosphite Toothpaste versus 1450 ppm Fluoride Toothpaste for Preventing Cavities
Official title: Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
Run by Dr. Kurt Wolff GmbH & Co. KG · NCT07068204 · Data updated 2026-11-12
This will test whether a toothpaste containing 2% calcium hypophosphite prevents cavities as well as a standard 1450 ppm fluoride toothpaste in people with at least 10 healthy molars and premolars.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Dr. Kurt Wolff GmbH & Co. KG Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Bialystok, Poland and 1 other locations) |
| Status | Recruiting |
| Started | January 22, 2026 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07068204 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with at least 10 healthy molars and premolars who can use an electric toothbrush and interdental floss, agree to bitewing radiographs and DIAGNOcam exams, and have no major oral health contraindications.
✕Probably not a fit
People with three or more untreated caries, xerostomia, active chemo/radiation, severe periodontitis, current orthodontic appliances, known hypersensitivity to toothpaste ingredients, or who cannot maintain the required oral hygiene routines are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, interventional non-inferiority study compares a 2% calcium hypophosphite toothpaste to a sodium fluoride toothpaste (1450 ppm F) for prevention of dental caries. Participants with at least 10 healthy molars and premolars will be enrolled at two university dental centers in Poland and asked to use an electric toothbrush and interdental floss while using the assigned toothpaste. Clinical examinations including bitewing radiographs and intraoral DIAGNOcam imaging will be used to monitor caries development over follow-up visits. Key exclusions include untreated multiple caries, xerostomia, ongoing chemo/radiation, severe periodontitis, orthodontic treatment, or hypersensitivity to toothpaste ingredients.
Why it matters
Potential benefit: If successful, the calcium hypophosphite toothpaste could provide an effective alternative to standard fluoride toothpaste for preventing cavities.
How similar studies have gone: Some calcium- and phosphate-based remineralizing toothpastes have shown promise in prior studies, but head-to-head non-inferiority data specifically for 2% calcium hypophosphite versus 1450 ppm fluoride are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 * 3 or more carious lesions/restorations in last 36 months until Baseline Visit * Teeth missing due to caries in last 36 months until Baseline Visit
Where it's running
-
Poznan University of Medical Sciences, Department of Integrated Dentistry
Poznan, Poland, Poland Recruiting -
Department of Integrated Dentistry Medical University of Białystok
Bialystok, Poland, Poland Not yet recruiting
Study contacts
- Principal investigator: Elzbieta Paszynska, Prof., DDS, Msc, PhD — Poznan University of Medical Sciences
- Study coordinator: Joachim Enax, PhD
- Email: joachim.enax@drwolffgroup.com
- Phone: +49 521 8808 6064
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.