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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Caries, Dental Calcium Hypophosphite Fluoridation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2% Calcium Hypophosphite Toothpaste

Group Type EXPERIMENTAL

2% Calcium Hypophosphite Toothpaste

Intervention Type 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)

Group Type PLACEBO_COMPARATOR

Sodium Fluoride Toothpaste (1450 ppm F)

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes