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Mouthrinses for Oral Microbiome Health (Microbiome Trial)
N/A
Recruiting
Led By Dr. Petra Wilder-Smith
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 180
Summary
This trial studies the effects of two mouthwashes on bacteria and 3 viruses in the mouth and gut. Participants will make 5 visits over 180 days, spending 2.5 hours in total. Fecal matter will be collected in some.
Who is the study for?
This trial is for healthy individuals aged 18-25 with either good gum health or gums that bleed when brushing. Participants must have at least 20 teeth, not be on antibiotics in the last 3 months, and agree to attend all study visits and procedures.
What is being tested?
The study tests how Listerine mouthwash and Lumineux Oral Essentials affect oral and gut bacteria plus three types of viruses. Participants will use one of these rinses or water twice daily for about six months, with five check-in visits.
What are the potential side effects?
Potential side effects may include changes in taste sensation, dryness or irritation inside the mouth, allergic reactions to ingredients in the mouthwashes, or an imbalance in oral/gut microbiome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
total bacterial load and mRNA analysis
viral load and mRNA analysis using RT-PCR
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumineux Oral Essentials rinseExperimental Treatment1 Intervention
rinse twice daily for 1 min with Lumineux Oral Essentials rinse
Group II: Listerine rinseExperimental Treatment1 Intervention
rinse twice daily for 1 min with Listerine rinse
Group III: Water rinsePlacebo Group2 Interventions
rinse twice daily for 1 min with water
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
564 Previous Clinical Trials
1,932,396 Total Patients Enrolled
Dr. Petra Wilder-SmithPrincipal InvestigatorBeckman Laser Institute University of California Irvine
1 Previous Clinical Trials
275 Total Patients Enrolled
Petra Wilder-Smith, DDS, PhDPrincipal InvestigatorUniversity of Calfornia Irvine
2 Previous Clinical Trials
2,577 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have fewer than 20 teeth, not counting wisdom teeth.I am between 18 and 25 years old and not pregnant or breastfeeding.I am willing and able to sign the informed consent form.My gums are healthy or they bleed when I brush.I have not taken antibiotics in the last 3 months.My gums are healthy or they bleed when I brush.
Research Study Groups:
This trial has the following groups:- Group 1: Listerine rinse
- Group 2: Water rinse
- Group 3: Lumineux Oral Essentials rinse
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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