2% Calcium Hypophosphite Toothpaste versus 1450 ppm Fluoride Toothpaste for Preventing Cavities
Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
NA · Dr. Kurt Wolff GmbH & Co. KG · NCT07068204
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Dr. Kurt Wolff GmbH & Co. KG (industry) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Bialystok, Poland and 1 other locations) |
| Trial ID | NCT07068204 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bialystok, Poland and 1 other locations
- Department of Integrated Dentistry Medical University of Białystok — Bialystok, Poland, Poland (NOT_YET_RECRUITING)
- Poznan University of Medical Sciences, Department of Integrated Dentistry — Poznan, Poland, Poland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Caries, Dental, Calcium Hypophosphite, Fluoridation