PeriodontitisNCT07397312
A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
A study testing Toothpaste in people with Periodontitis, run by Periotrap Pharmaceuticals GmbH at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesGermany
- Study dates
- 28 Jul 2025to 31 Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Good general health with no clinically significant 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.
Who cannot join
- A participant who is an employee of the investigational 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 hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Show all 21Show fewer
- 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, immunosuppressants), 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites, 4 recruiting
- Active, not recruiting
Dr. Hofmann
Bietigheim-Bissingen, 74321
- Recruiting
Dr. T. Schütz
Borna, 04552
Dr. Schütz, +493433903962, praxis.dr.t.schuetz@t-online.de
Schütz, Dr.
- Recruiting
Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
Halle, Saxony-Anhalt, 06112
Stefan Reichert, apl. Prof. Dr. med. dent. habi, +49 345 557 3762, stefan.reichert@uk-halle.de
Stefan Reichert, apl. Prof. Dr. med. dent. habi
- Recruiting
Zahnzentrum Halle
Halle, Saxony-Anhalt, 06114
Arne F. Boeckler, apl. Prof. Dr. med. dent. habi, +49 345 2909 002, info@zahnzentrum-halle.de
Arne F. Boeckler, apl. Prof. Dr. med. dent. habi
- Recruiting
Dr. G. Jungbauer
Straubing, 94315
Dr. Jungbauer, +49 942110777, gert.jungbauer@unibe.ch
Gert Jungbauer, Dr.
About this study
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.
- Conditions
- Periodontitis
- Being tested
- Toothpaste
- Keywords
- periodontitis, toothpaste
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothpasteOther
brushing teeth with toothpaste twice a day for and refrain from mouth rinsing after spitting out
| Study group | Role | What they receive |
|---|---|---|
| toothpaste | Experimental | Not described Receives: Other: Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy before and after 3 months of using newly developed microbiome-modulating toothpaste
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start28 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Periotrap Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397312
- Sponsor's protocol ID
- CosTP-001
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
- ClinicalTrials.gov ID
- NCT07397312
- Acronym / sponsor ID
- CosTP-001
- Conditions
- Periodontitis
- Keywords
- periodontitis, toothpaste
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Periotrap Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| toothpaste | Experimental | Other: Toothpaste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Good general health with no clinically significant 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.
- Participant with at least 16 natural, permanent teeth.
- A participant who gets regularly professional tooth cleaning in a frequence of once to twice yearly.
Key exclusion criteria (21 listed)
- A participant who is an employee of the investigational 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.
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 |
|---|---|---|
| Toothpastebrushing teeth with toothpaste twice a day for and refrain from mouth rinsing after spitting out | Other | toothpaste |
Primary outcome
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.
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 1 Sep 2026.
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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.
Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
Halle, Germany
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste in people with Periodontitis, run by Periotrap Pharmaceuticals GmbH at 5 sites in Germany.
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 7 inclusion and 21 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 1 Sep 2026.