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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDr. Joachim Enax

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 2% Calcium Hypophosphite Toothpaste
  • Sodium Fluoride Toothpaste (1450 ppm F)

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr. Joachim Enax

Lead sponsor

Dr. Kurt Wolff GmbH & Co. KG

Sponsor institution

Department of Integrated Dentistry Medical University of Białystok

Collaborator

Poznan University of Medical Sciences, Department of Integrated Dentistry

Collaborator