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

NCT07068204 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Caries, Dental
  • Calcium Hypophosphite
  • Fluoridation

Interventions

DEVICE

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).

DEVICE

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).

Sponsors & Collaborators

  • Department of Integrated Dentistry Medical University of Białystok

    collaborator UNKNOWN

  • Poznan University of Medical Sciences, Department of Integrated Dentistry

    collaborator UNKNOWN

  • Dr. Joachim Enax

    lead INDUSTRY

Principal Investigators

  • Elzbieta Paszynska, Prof., DDS, Msc, PhD · Poznan University of Medical Sciences

  • Malgorzata Pawinska, Assoc. Prof., DDS, PhD · Department of Integrated Dentistry Medical University of Białystok

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068204 on ClinicalTrials.gov