A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeriotrap Pharmaceuticals GmbH
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Participant with at least 16 natural, permanent teeth.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Toothpaste
Other interventionbrushing teeth with toothpaste twice a day for and refrain from mouth rinsing after spitting out
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: toothpasteExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov