Caries, DentalNCT07068204
Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)
A study testing 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F) in people with Caries, Dental and Calcium Hypophosphite, run by Dr. Joachim Enax at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental, Calcium Hypophosphite, Fluoridation
- What is being tested?
- 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 2 sitesPoland
- Study dates
- 22 Jan 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Not yet recruiting
Department of Integrated Dentistry Medical University of Białystok
Bialystok, Poland, 15-276
Małgorzata Pawińska, DDS, PhD, +48 693 245 095, malgosiapaw@interia.pl
- Recruiting
Poznan University of Medical Sciences, Department of Integrated Dentistry
Poznan, Poland, 60-812
Elzbieta Paszynska, DDS, PhD, +48 601 55 11 89, paszynska@ump.edu.pl
About this study
Official title: Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
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
- Being tested
- 2% Calcium Hypophosphite Toothpaste, Sodium Fluoride Toothpaste (1450 ppm F)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Calcium Hypophosphite ToothpasteDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 2% Calcium Hypophosphite Toothpaste | Experimental | Not described Receives: Device: 2% Calcium Hypophosphite Toothpaste |
| Sodium Fluoride Toothpaste (1450 ppm F) | Placebo comparator | Not described Receives: Device: Sodium Fluoride Toothpaste (1450 ppm F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index
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).
Measured: Day 1, Day 182±28, Day 365±28 vs. Day 546±28
Secondary outcomes (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
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).
Measured: 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
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
Measured: Day 1, Day 182±28, Day 365±28 vs. Day 546±28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start22 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Joachim Enax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Integrated Dentistry Medical University of Białystok, Poznan University of Medical Sciences, Department of Integrated Dentistry
- Responsible party
- Sponsor-investigator, Dr. Joachim Enax, Dr. Kurt Wolff GmbH & Co. KG
- Investigators
- Elzbieta Paszynska, Prof., DDS, Msc, PhD, Principal investigator, Poznan University of Medical SciencesMalgorzata Pawinska, Assoc. Prof., DDS, PhD, Principal investigator, Department of Integrated Dentistry Medical University of Białystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068204
- Sponsor's protocol ID
- CA2-04/2024
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
- ClinicalTrials.gov ID
- NCT07068204
- Acronym / sponsor ID
- CA2-04/2024
- Conditions
- Caries, Dental, Calcium Hypophosphite, Fluoridation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Dr. Joachim EnaxIndustry (pharma, biotech, devices)
- Collaborators
- Department of Integrated Dentistry Medical University of Białystok, Poznan University of Medical Sciences, Department of Integrated Dentistry
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Calcium Hypophosphite Toothpaste | Experimental | Device: 2% Calcium Hypophosphite Toothpaste |
| Sodium Fluoride Toothpaste (1450 ppm F) | Placebo comparator | Device: Sodium Fluoride Toothpaste (1450 ppm F) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Calcium Hypophosphite ToothpasteOral 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 | 2% Calcium Hypophosphite Toothpaste |
| 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). | Device | Sodium Fluoride Toothpaste (1450 ppm F) |
Primary outcome
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elzbieta Paszynska, Prof., DDS, Msc, PhD principal investigator
Poznan University of Medical Sciences
Malgorzata Pawinska, Assoc. Prof., DDS, PhD principal investigator
Department of Integrated Dentistry Medical University of Białystok
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F) in people with Caries, Dental and Calcium Hypophosphite, run by Dr. Joachim Enax at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joachim Enax, PhD (+49 521 8808 6064, joachim.enax@drwolffgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.