Pilot test of a commercial toothpaste for periodontitis
A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
This test will see if brushing twice daily with a commercial toothpaste that contains a new ingredient helps people with periodontitis protect their oral microbiome between regular cleanings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Periotrap Pharmaceuticals GmbH Industry-sponsored |
| Locations | 3 sites (Bietigheim-Bissingen and 2 other locations) |
| Trial ID | NCT07397312 on ClinicalTrials.gov |
What this trial studies
This multicenter, controlled pilot enrolls people with periodontitis who receive professional tooth cleaning every 3–6 months and whose dental biofilm contains Porphyromonas gingivalis. Participants with at least 16 natural teeth will be assigned to use the allocated commercial dentifrice, which contains standard ingredients like fluoride plus a novel compound, and will brush twice daily for three months. The study compares oral hygiene using the test dentifrice during the non-treatment interval between two recalls, with clinical periodontal measures and microbiome-related outcomes recorded. The goal is to determine whether the product supports a eubiotic oral microbiome and helps maintain periodontal health between professional cleanings.
Who should consider this trial
Good fit: Adults with periodontitis who have at least 16 natural teeth, receive regular professional cleanings (about once to twice yearly), and have detectable Porphyromonas gingivalis in their dental biofilm are ideal candidates.
Not a fit: People without periodontitis, those lacking P. gingivalis, individuals with fewer than 16 natural teeth, or those unable to follow twice-daily brushing or attend visits are unlikely to benefit.
Why it matters
Potential benefit: If successful, the toothpaste could help maintain a healthier oral microbiome and reduce periodontal deterioration between professional cleanings.
How similar studies have performed: While fluoride and mechanical brushing are proven for oral health, the specific novel compound in this toothpaste is relatively untested in clinical trials for modifying the oral microbiome, so direct evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bietigheim-Bissingen and 2 other locations
- Dr. Hofmann — Bietigheim-Bissingen, Germany (Not_yet_recruiting)
- Dr. T. Schütz — Borna, Germany (Recruiting)
- Dr. G. Jungbauer — Straubing, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.