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

Launched by DR. JOACHIM ENAX · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new toothpaste containing 2% calcium hypophosphite works to prevent tooth decay (cavities) compared to a regular fluoride toothpaste, which is commonly used to protect teeth. The goal is to see if the new toothpaste is just as effective as the fluoride one in keeping teeth healthy.

People who might join this study need to be between about 6,500 and 16,400 years old (which seems like a typographical error—likely meaning ages 6 to 74) and have at least 10 healthy back teeth without any fillings or cavities. Participants should be willing to use an electric toothbrush and floss regularly, and agree to have dental X-rays and oral exams with a special camera. Those with untreated cavities, certain health issues affecting saliva or mouth health, ongoing orthodontic treatment, or pregnancy won’t be able to join. If accepted, participants will use one of the two toothpastes and have their oral health monitored over time to see which toothpaste better prevents new cavities. This study is not yet recruiting, but it aims to find safe and effective ways to keep teeth strong and healthy.

Gender

ALL

Eligibility 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