Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)

Dr. Joachim Enax

Status: Not yet enrolling

Conditions: Calcium Hypophosphite; Caries, Dental; Fluoridation

Treatments: Device: Sodium Fluoride Toothpaste (1450 ppm F); Device: 2% Calcium Hypophosphite Toothpaste

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07068204

CA2-04/2024

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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164 participants in 2 patient groups, including a placebo group

2% Calcium Hypophosphite Toothpaste

Experimental group

Treatment:

Device: 2% Calcium Hypophosphite Toothpaste

Sodium Fluoride Toothpaste (1450 ppm F)

Placebo Comparator group

Treatment:

Device: Sodium Fluoride Toothpaste (1450 ppm F)