Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)
Recruiting now · Not applicable
Conditions studied: Caries, Dental, Calcium Hypophosphite, Fluoridation
In brief
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.
Key facts
- Study ID
- NCT07068204
- Run by
- Dr. Joachim Enax
- People needed
- 164
- Starts
- 2026-01-22
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Poznan University of Medical Sciences, Department of Integrated Dentistry — Poznan, Poland, Poland (enrolling)
- Department of Integrated Dentistry Medical University of Białystok — Bialystok, Poland, Poland
Full record on ClinicalTrials.gov
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