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Recruiting NCT07068204

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

No phase Interventional Caries, Dental Calcium Hypophosphite Fluoridation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2% Calcium Hypophosphite Toothpaste, Sodium Fluoride Toothpaste (1450 ppm F).
Who it may be relevant to
Registry conditions: Caries, Dental, Calcium Hypophosphite, Fluoridation. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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).

Primary outcome measures

  • Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index [Time frame: Day 1, Day 182±28, Day 365±28 vs. Day 546±28]
Secondary outcome measures (2)
  • Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of interproximal caries lesions [Time frame: Day 1 vs. Day 546±28]
  • Evaluate the efficacy of 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of dental plaque deposition using the Plaque Control Record (PCR) index [Time frame: Day 1, Day 182±28, Day 365±28 vs. Day 546±28]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Poland · 2 centers
  • Department of Integrated Dentistry Medical University of Białystok — Bialystok
  • Poznan University of Medical Sciences, Department of Integrated Dentistry — Poznan

Identifiers

NCT: NCT07068204 · CA2-04/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗