Ireland
--:--IST
Recruiting Not applicable

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

NCT07068204 · tracked via the Priya Life Science Poland tracker
Sponsor
Dr. Joachim Enax
Phase
Not applicable
Started
2026-01-22
Last updated
2026-04-13

Condition(s) studied

Caries, DentalCalcium HypophosphiteFluoridation

Investigational drug(s) / intervention(s)

2% Calcium Hypophosphite ToothpasteSodium Fluoride Toothpaste (1450 ppm F)

2% Calcium Hypophosphite Toothpaste: Oral hygiene instruction and regular application of the 2% Calcium Hypophosphite Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).

Sodium Fluoride Toothpaste (1450 ppm F): Oral hygiene instruction and regular application of the Sodium Fluoride Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).

Study 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

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index — Day 1, Day 182±28, Day 365±28 vs. Day 546±28
    Comparison between the 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects showing no increase in overall Decay-Missing-Filled index during the observation period of 546 days (assessed by the investigator).

Trial sites (2)

FacilityCityRegionStatus
Department of Integrated Dentistry Medical University of Białystok Bialystok Poland Not Yet Recruiting
Poznan University of Medical Sciences, Department of Integrated Dentistry Poznan Poland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07068204 on ClinicalTrials.gov ↗ ← All trials in Poland