Recruiting

Mouthrinse

Sponsor:

UCLA

Code:

NCT05603650

Conditions

Oral Bacterial Infection

Oral Infection

Microbial Colonization

Viral Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lumineux Oral Essentials rinse

Listerine rinse

Study Details

Brief summary:

The purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. The participant will be randomly allocated to rinse their mouth twice daily either with Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water. The overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit.

Conditions

Oral Bacterial Infection

Oral Infection

Microbial Colonization

Viral Infection

Study ID

NCT05603650

Start date

Sep 1, 2021

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Eligible men and non-pregnant and non-lactating women of all races age 18-25.
  • Volunteers must consent to participate in all scheduled exam visits and procedures.
  • Volunteers must be available for follow up on the telephone.
  • Healthy gums or gums that bleed when you brush them.

Exclusion Criteria:

  • Volunteers unable or unwilling to sign the informed consent form.
  • Less than 20 teeth (excluding third molars).
  • Individuals who have taken antibiotics in the previous 3 months.
  • Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Water rinse

rinse twice daily for 1 min with water

experimental: Lumineux Oral Essentials rinse

rinse twice daily for 1 min with Lumineux Oral Essentials rinse

experimental: Listerine rinse

rinse twice daily for 1 min with Listerine rinse

Interventions

Lumineux Oral Essentials rinse

mouthrinse

Listerine rinse

mouthrinse

Primary outcome measure

  • total bacterial load and mRNA analysis [ Time Frame: Day 0 ]
  • total bacterial load and mRNA analysis [ Time Frame: Day 30 ]
  • total bacterial load and mRNA analysis [ Time Frame: Day 60 ]
  • total bacterial load and mRNA analysis [ Time Frame: Day 90 ]
  • total bacterial load and mRNA analysis [ Time Frame: Day 180 ]
  • viral load and mRNA analysis using RT-PCR [ Time Frame: Day 0 ]
  • viral load and mRNA analysis using RT-PCR [ Time Frame: Day 30 ]
  • viral load and mRNA analysis using RT-PCR [ Time Frame: Day 60 ]
  • viral load and mRNA analysis using RT-PCR [ Time Frame: Day 90 ]
  • viral load and mRNA analysis using RT-PCR [ Time Frame: Day 180 ]

Central Contacts and Locations

Central contacts

Nicole Wakida, PhD

949-824-4360nwakida@uci.edu

Locations

Beckman Laser Institute and Medical Clinic

Recruiting

Irvine, California, United States, 92612

Contacts

Nicole Wakida, PhD

949-824-4360nwakida@uci.edu

Principal Investigator:

Petra Wilder-Smith, DDS, PhD

More Information

Sponsor

University of California, Irvine

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Oral Microbiome
  • Fecal Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2025-12-17.