Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fl… (NCT07068204) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)
Poland164 participantsStarted 2026-01-22
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index
Timeframe: Day 1, Day 182±28, Day 365±28 vs. Day 546±28