Actively Recruiting
A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
Led by Periotrap Pharmaceuticals GmbH · Updated on 2026-02-09
28
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the study procedures and restrictions and agrees to participate by signing informed consent
- Is in good general health with no significant medical history abnormalities
- Has no conditions affecting safety or ability to follow study requirements
- Has at least 16 natural, permanent teeth
- Receives professional tooth cleaning once or twice yearly
- Has biofilm containing Porphyromonas gingivalis
You will not qualify if you...
- Is an employee or immediate family of the investigational site or sponsor involved in the study
- Participated in other investigational studies within 30 days before or during this study
- Has acute or chronic medical, psychiatric conditions, or lab abnormalities increasing study risk or interfering with results
- Has serious or unstable clinical conditions like cardiovascular disease, diabetes, liver, bleeding, or kidney disorders
- Has a Plaque Control Record over 35%
- Is pregnant, planning pregnancy, or breastfeeding
- Has intolerance or allergy to study materials or ingredients
- Is unwilling or unable to follow lifestyle considerations
- Is a current smoker of more than 5 cigarettes per day
- Uses smokeless tobacco products or nicotine-based e-cigarettes
- Diagnosed with xerostomia or taking medications causing dry mouth
- Has history of alcohol or substance abuse within the last year
- Has severe oral conditions like necrotizing gingivitis or ulcers
- Previously enrolled in this study
- Used antibiotics within 3 months before or during the study
- Currently using anti-inflammatory or systemic medications affecting plaque or gum condition repeatedly for over 3 days during study
- Has untreated or uncontrolled periodontitis
- Has active caries compromising oral health or study outcomes
- Has orthodontic appliances except night guards
- Has dental conditions like overcrowding that could affect oral health or study results
AI-Screening
AI-Powered Screening
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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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