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

Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults

NCT07068204•Dr. Joachim Enax

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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
+1 more criteria

Key Dates

Start Date

September 1, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

September 3, 2025

Enrollment

164

ESTIMATED participants

Conditions

Caries, DentalCalcium HypophosphiteFluoridation

Interventions

2% Calcium Hypophosphite Toothpaste

DEVICE

Sodium Fluoride Toothpaste (1450 ppm F)

DEVICE

Contacts

Joachim Enax, PhD

CONTACT

+49 521 8808 6064 joachim.enax@drwolffgroup.com

Clarissa Masur, PhD

CONTACT

+49 521 8808 319 clarissa.masur@drwolffgroup.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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