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

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

Recruiting
18-45 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Caries
    Dental
    Calcium Hypophosphite
    Fluoridation

NCT07068204

Dr. Joachim Enax

13 May 2026

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