Actively Recruiting
A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product) for Periodontitis
Led by Periotrap Pharmaceuticals GmbH · Updated on 2026-02-09
28
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a commercial toothpaste containing a novel compound aimed at supporting a healthy oral microbiome in people with periodontitis. This multi-center controlled clinical study focuses on volunteers who receive professional tooth cleaning every 3 to 6 months during a non-treatment period between supportive periodontitis therapy sessions. The study aims to determine how well this toothpaste works when used at home. Participants will brush their teeth twice daily with the allocated toothpaste for three months. The toothpaste includes common ingredients like sodium fluoride and cleaning agents, plus a new compound designed to benefit the oral microbiome. The study involves monitoring the participants during this 3-month period while they maintain their usual professional tooth cleaning routine. During the study, participants will be assessed before and after the 3 months of toothpaste use to evaluate its efficacy. Researchers will collect data on oral health, including the presence of specific bacteria and plaque control. Participants will be monitored for safety and adherence, and the main outcome is the toothpaste's effect on the oral microbiome after 12 weeks of use.
CONDITIONS
Brief Title
A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Demonstrates understanding of the study procedures and gives voluntary informed consent.
- Good general health with no significant medical abnormalities.
- No condition affecting safety or ability to follow study requirements.
- Has at least 16 natural, permanent teeth.
- Receives professional tooth cleaning once or twice yearly.
- Dental biofilm contains Porphyromonas gingivalis.
- Is 18 years old or older.
You will not qualify if you...
- Employee or immediate family of the study site or sponsor involved in the study.
- Participation in other investigational studies within 30 days before or during this study.
- Acute or chronic medical or psychiatric conditions increasing risk or affecting study results.
- Serious or unstable health conditions like cardiovascular disease, diabetes, liver, bleeding, or kidney disorders.
- Plaque Control Record greater than 35%.
- Pregnant, planning pregnancy, or breastfeeding.
- Known intolerance or hypersensitivity to study materials or ingredients.
- Unwilling or unable to comply with lifestyle requirements.
- Current smoker of more than 5 cigarettes per day.
- Use of smokeless tobacco products.
- Diagnosis of xerostomia or medications causing dry mouth.
- Recent history of alcohol or substance abuse within the last year.
- Severe oral conditions compromising oral health or study outcomes.
- Previous enrollment in this study.
- Use of antibiotics within 3 months before or during the study.
- Use of anti-inflammatory or systemic medications affecting plaque or gums repeatedly for more than 3 days during the study.
- Untreated or uncontrolled periodontitis.
- Active dental caries affecting oral health or study outcomes.
- Presence of orthodontic appliances except night guards.
- Dental conditions like overcrowding that could affect study outcomes or oral health.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants brush their teeth twice a day with the study toothpaste and refrain from mouth rinsing after spitting out.
Trial Site Locations
Total: 3 locations
1
Dr. Hofmann
Bietigheim-Bissingen, Germany, 74321
Not Yet Recruiting
2
Dr. T. Schütz
Borna, Germany, 04552
Actively Recruiting
3
Dr. G. Jungbauer
Straubing, Germany, 94315
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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