A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
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 determin
| Condition(s) | Periodontitis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. 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. |
| Who can participate | 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 par |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Periotrap Pharmaceuticals GmbH |
| Locations | Bietigheim-Bissingen, Germany; Borna, Germany; Straubing, Germany |
| Start date | 2025-07-28 |
| NCT ID | NCT07397312 |
| Official listing | https://clinicaltrials.gov/study/NCT07397312 |