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

February 2, 2026 updated by: Periotrap Pharmaceuticals GmbH
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bietigheim-Bissingen, Germany, 74321
        • Not yet recruiting
        • Dr. Hofmann
        • Contact:
        • Principal Investigator:
          • Hofmann, Dr.
      • Borna, Germany, 04552
        • Recruiting
        • Dr. T. Schütz
        • Contact:
        • Principal Investigator:
          • Schütz, Dr.
        • Sub-Investigator:
          • Schmidtke
      • Straubing, Germany, 94315
        • Recruiting
        • Dr. G. Jungbauer
        • Contact:
        • Principal Investigator:
          • Gert Jungbauer, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 has a Plaque Control Record (PCR) > 35 %.
  • 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.
  • A participant who is unwilling or unable to comply with the lifestyle considerations.
  • Participant who is a current smoker (more than 5 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: toothpaste
Other: Toothpaste
brushing teeth with toothpaste twice a day for and refrain from mouth rinsing after spitting out

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From enrollment to the end of treatment at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Periotrap Pharmaceuticals GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CosTP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on Toothpaste

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe