Evaluation of the Mouthwash Effect on Maintaining Healthy Microbiome in Healthy Mouth.
ConditionHealthy Mouth Microbiome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLacer S.A.
About this trial
The goal of this study is to learn if mouthwash works to maintain healthy microbiome in subjects with healthy mouth. It will also learn about its safety. The main question it aims to answer is:
• Does the mouthwash helps to maintain healthy microbiome in balance?
Participants will:
* Use mouthwash twice a day for 2 months * Visit the clinic as scheduled per protocol for evaluations
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy female and male subjects (without any specific repartition) subjects
Subjects of Caucasian ethnicity
Subjects aged between 18 and 55 years (extremes included)
Subjects with a (resting, not stimulated) salivary pH in the range 6.0-7.0
Disqualifiers
Subjects who do not meet the inclusion criteria
Subjects with active dental caries
Subjects with acute or chronic diseases (e.g. diabetes) able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements;
Subjects participating or planning to participate in other clinical trials
Trial design
Design model
Single group
Treatments tested in this trial
Mouthwash
Other interventionMouthwash will be used twice daily for 2 months
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: mouthwashExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evolution from Baseline in the microbiome at 2 Months.
Microbiome evaluation would be done by 16S rRNA gene amplification
Time frame
From enrollment to the end of study at 2 monthsLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: