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RecruitingNCT07397312Updated Sep 1, 2026

A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)

An interventional study of Toothpaste in Periodontitis, sponsored by Periotrap Pharmaceuticals GmbH. Recruiting at 5 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Periotrap Pharmaceuticals GmbH · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2025, registered Feb 2026).
  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This clinical multi-center, controlled, study will be carried out in volunteers with every 3- to 6-months professional tooth cleaning during their non-treatment period between 2 re-calls of a supportive periodontitis therapy regime. The efficacy of domestic oral hygiene by using a commercial dentifrice will be determined. Besides regularly used ingredients such as NaF and cleaning bodies the dentifrice contains a novel compound, which may be beneficial for the protection of an eubiotic oral microbiome. During the 3-month study period, participants will brush with their allocated study product twice daily.

02

Conditions studied

  • Periodontitis

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Keywords

  • periodontitis
  • toothpaste
03

In context

Periodontitis

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's planned enrollment of 28 is below the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

This is the only study on the registry with Periotrap Pharmaceuticals GmbH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written and has received a signed and dated copy of the informed consent form.
  • Good general health with no and relevant abnormalities of medical history.
  • Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.

At Screening (Visit 1):

  • Participant with at least 16 natural, permanent teeth.
  • A participant who gets regularly professional tooth cleaning in a frequence of once to twice yearly.
  • Participant whose biofilm contains at least Porphyromonas gingivalis.

Exclusion criteria

Exclusion Criteria:

  • A participant who is an employee of the site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a sponsor's employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
  • A participant with an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • A participant who has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, bleeding disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
  • A participant who plans to get pregnant during the study or is already pregnant (pregnancy testing) or breastfeeding.
  • A participant who is known or suspected of intolerance or to the study materials (or closely related compounds) or any of their stated ingredients.
  • A participant who is unwilling or unable to comply with the lifestyle considerations.
  • Participant who is a current smoker (more than 10 cigarettes per day).
  • Participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
  • A participant who is diagnosed with xerostomia or is taking any medication that is causing xerostomia.
  • A participant who has a recent history (within the last year) of alcohol or other substance abuse.
  • A participant who has a severe oral condition (for example, necrotizing gingivitis/periodontitis or oral or peri-oral ulceration) that could compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
  • A participant who has previously been enrolled in this study.

Medication exclusions at screening (Visit 1):

  • A participant who is using any antibiotic medication within 3 months prior to inclusion or at any time during the study.
  • A participant who is currently taking an anti-inflammatory or systemic medication (for example, ), which could affect plaque/gingival condition (for example, ibuprofen, aspirin, cyclosporin, phenytoin, calcium channel blockers) repeatedly for more than 3 consecutive days within study participation.

Periodontal and dental exclusions:

  • A participant who has a formally untreated or not controlled periodontitis.
  • A participant who has active caries that could compromise study outcomes or the oral health of the participant if they participate in the study.
  • A participant who has an orthodontic appliance (bands, appliances, or fixed/ removable retainers except night guards).
  • A participant who has any dental condition (for example, overcrowding) that could compromise study outcomes or the oral health of the participant if they participate in the study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    toothpaste

    Other: Toothpaste

Interventions

  • OtherToothpaste

    brushing teeth with toothpaste twice a day for and refrain from mouth rinsing after spitting out

06

What researchers measure

Primary outcomes

  1. Efficacy before and after 3 months of using newly developed microbiome-modulating toothpaste

    Time frame: From enrollment to the end of treatment at 12 weeks.

07

Study locations

4 of 5 sites recruiting
  • Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
    Halle, Saxony-Anhalt 06112, Germany
    Recruiting
    • Stefan Reichert, apl. Prof. Dr. med. dent. habi · Contactstefan.reichert@uk-halle.de · +49 345 557 3762
    • Stefan Reichert, apl. Prof. Dr. med. dent. habi · Principal investigator
  • Zahnzentrum Halle
    Halle, Saxony-Anhalt 06114, Germany
    Recruiting
    • Arne F. Boeckler, apl. Prof. Dr. med. dent. habi · Contactinfo@zahnzentrum-halle.de · +49 345 2909 002
    • Arne F. Boeckler, apl. Prof. Dr. med. dent. habi · Principal investigator
    • Bacher · Sub investigator
    • Gräfe · Sub investigator
  • Dr. Hofmann
    Bietigheim-Bissingen, 74321, Germany
    Active, not recruiting

    Not enrolling at this site.

  • Dr. T. Schütz
    Borna, 04552, Germany
    Recruiting
  • Dr. G. Jungbauer
    Straubing, 94315, Germany
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Dec 2026, 17 months after the start.

Of 494 interventional studies with no phase under Periodontitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 17 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2026
First posted
Feb 9, 2026
StartActual
Jul 28, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07397312
Lead sponsor
Periotrap Pharmaceuticals GmbH
Responsible party
Sponsor
First posted
Feb 9, 2026
Start date
Jul 28, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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