Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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