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NCT Number: NCT07068204

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

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.

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Key information

Conditions

Caries, Dental Calcium Hypophosphite Dental Caries Fluoridation Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Integrated Dentistry Medical University of Białystok, Bialystok, Poland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% Calcium Hypophosphite Toothpaste

Device

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)

Device

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 outcomes

  1. 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

    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).

Secondary outcomes

  1. 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

    Comparison between 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects with no change in mineral density, as analyzed by DIAGNOcam Full Vision HD using near-infrared laser transillumination, over an observation period of 546 days (assessed by the investigator).

  2. 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

    At the study visits, a suitable disclosing solution such as Bismarck Brown, Diaplac or similar is painted on tooth surfaces. After the subject has rinsed, the investigator (using an explorer or a tip of a probe) examines each stained surface for soft accumulations at the dentogingival junction. After all teeth have been examined and scored, the index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces.

    Plaque Control Record Index Calculation = The number of plaque containing surfaces / The total number of available surfaces

Study contacts

Contact information is provided by the study sponsor or research team.

Clarissa Masur, PhD

CONTACT

[email protected]

+49 521 8808 319

Joachim Enax, PhD

CONTACT

[email protected]

+49 521 8808 6064

Sponsors and collaborators

Lead sponsor

Dr. Joachim Enax

Industry

Collaborators

  • Department of Integrated Dentistry Medical University of Białystok
  • Poznan University of Medical Sciences, Department of Integrated Dentistry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 16, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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