Mouthrinses for Oral Microbiome Health

(Microbiome Trial)

Recruiting at 1 trial location

Overseen By Nicole Wakida, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Antibiotics

Disqualifiers: Less than 20 teeth, others

Compensation: Varies

Number of Visits: 5

Duration: 180 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude individuals who have taken antibiotics in the previous 3 months.

Is the use of mouthrinses like Listerine and Lumineux generally safe for humans?

Mouthrinses like Listerine and Lumineux are generally considered safe for humans, with studies showing they can reduce bacteria in the mouth and help with oral health. However, some risks include potential effects on salivary flow and concerns about oral cancer with long-term use, so it's important to follow usage guidelines. ^{1 2 3 4 5}

How is the mouthrinse treatment for oral microbiome health different from other treatments?

This treatment is unique because it uses specific mouthrinses like Listerine and Lumineux Oral Essentials, which are known for their antimicrobial properties that help reduce bacteria in the mouth, prevent plaque buildup, and support oral health. Unlike some other treatments, these mouthrinses can also help decrease bacteria aerosolized during dental procedures and have anti-Candida properties, making them beneficial for patients with weakened immune systems. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Listerine rinse and similar mouthwashes for oral microbiome health?

Research shows that Listerine Antiseptic can significantly reduce bacteria in the mouth, helping to control plaque and gingivitis. It also has anti-Candida properties, which can be beneficial for people with weakened immune systems. ^{1 2 7 10 11}

Who Is on the Research Team?

Petra Wilder-Smith, DDS, PhD

Principal Investigator

University of Calfornia Irvine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Volunteers must be available for follow up on the telephone

My gums are healthy or they bleed when I brush.

Volunteers must consent to participate in all scheduled exam visits and procedures

Exclusion Criteria

I have fewer than 20 teeth, not counting wisdom teeth.

I am willing and able to sign the informed consent form.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants rinse twice daily with either Listerine, Lumineux Oral Essentials, or water for 180 days

180 days

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Listerine rinse
• Lumineux Oral Essentials rinse

Trial Overview 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.

How Is the Trial Designed?

Group I: Lumineux Oral Essentials rinse Experimental Treatment 1 Intervention

rinse twice daily for 1 min with Lumineux Oral Essentials rinse

Group II: Listerine rinse Experimental Treatment 1 Intervention

rinse twice daily for 1 min with Listerine rinse

Group III: Water rinse Placebo Group 2 Interventions

rinse twice daily for 1 min with water

Listerine rinse is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Listerine for:

• Gingivitis
• Bad Breath
• Plaque Control
• Tartar Control

Approved in European Union as Listerine for:

• Gingivitis
• Bad Breath
• Plaque Control
• Tartar Control

Approved in Canada as Listerine for:

• Gingivitis
• Bad Breath
• Plaque Control
• Tartar Control

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

Mouth rinses containing chlorhexidine gluconate or essential oils have been shown to significantly reduce plaque and gingivitis, making them effective adjuncts to oral hygiene practices based on a review of multiple studies.

Cetylpyridinium chloride offers limited benefits compared to control rinses, and there is insufficient evidence regarding the effectiveness of aloe vera gel, while all tested rinses were found to be safe with no significant impact on salivary flow rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiseptic mouth rinses: an update on comparative effectiveness, risks and recommendations. Osso, D., Kanani, N.[2022]

Using Listerine Antiseptic as a subgingival irrigant significantly reduces both anaerobic and aerobic bacteria linked to bacteremia before dental scaling procedures.

Both Listerine and chlorhexidine gluconate are effective in reducing bacteria aerosolized during dental procedures and have additional benefits, such as anti-Candida properties for immunosuppressed patients and aiding in wound healing after periodontal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded and future uses of mouthrinses. Ciancio, S.[2019]

A 6-month study involving 83 subjects using Listerine Antiseptic showed no significant changes in oral microbial populations, indicating that long-term use does not lead to an increase in harmful oral pathogens.

The study found no emergence of resistant microbial forms or increases in opportunistic pathogens, suggesting that Listerine Antiseptic is safe for long-term use without negatively impacting oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 6 months use of an antiseptic mouthrinse on supragingival dental plaque microflora. Minah, GE., DePaola, LG., Overholser, CD., et al.[2019]

0.2% chlorhexidine (CHX) mouthwash demonstrated significant antibacterial effects, inhibiting bacterial growth by an average of 18.38 mm in vitro, while Listerine® and Persica showed no inhibition.

In vivo, after two weeks of use, 0.2% CHX led to a mean reduction of 23.13 colony-forming units (CFU) in bacterial count, outperforming Listerine® and Persica, which reduced CFU by 19.75 and 13.5 respectively, compared to only 1 CFU reduction with water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Antimicrobial Effects of Three Different Mouthwashes. Haerian-Ardakani, A., Rezaei, M., Talebi-Ardakani, M., et al.[2022]

Rinsing with Listerine Antiseptic resulted in a significant 60%-65% reduction in viable salivary bacteria within 2 minutes, with effects lasting up to 60 minutes, compared to a control rinse that showed no significant change.

The study suggests that Listerine could be clinically useful as a pre-procedural rinse in dental settings to lower the number of microorganisms in the mouth, potentially reducing the risk of infection during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an antiseptic mouthrinse on salivary microbiota. DePaola, LG., Minah, GE., Overholser, CD., et al.[2006]

A study comparing LISTERINE Antiseptic (alcohol-based) and Crest Pro-Health Rinse (non-alcohol-based) found that both mouthrinses had similar effects on salivary flow and perceived dryness after 12 weeks of use in healthy adults.

There were no significant differences in dry mouth symptoms between the two mouthrinses, indicating that using an alcohol-based mouthrinse does not increase the risk of dry mouth compared to a non-alcohol-based option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two mouthrinses in relation to salivary flow and perceived dryness. Kerr, AR., Corby, PM., Kalliontzi, K., et al.[2015]

Preprocedural rinsing with Cool Mint Listerine Antiseptic mouthrinse led to a significant reduction of 92.1% in viable bacteria in dental aerosols immediately after rinsing, and 91.3% reduction 40 minutes later, based on two double-blind studies involving 36 healthy subjects.

These findings suggest that using Listerine before dental procedures could effectively lower the risk of cross-contamination in dental settings, making it a valuable practice for enhancing safety during treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of viable bacteria in dental aerosols by preprocedural rinsing with an antiseptic mouthrinse. Fine, DH., Furgang, D., Korik, I., et al.[2022]

The developed alcohol-free mouthwash with low chlorhexidine concentration effectively prevents oral infections in immunocompromised and cancer patients, showing strong antimicrobial activity against both planktonic and biofilm forms of Candida albicans.

The mouthwash also demonstrated efficacy against other harmful bacteria like Klebsiella pneumoniae, Pseudomonas aeruginosa, and MRSA, with its antiseptic effects comparable to those of commercially available alcohol-based mouthwashes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiseptic effect of a novel alcohol-free mouthwash: a convenient prophylactic alternative for high-risk patients. Bahna, P., Hanna, HA., Dvorak, T., et al.[2013]

In a study involving 160 healthy volunteers, both alcohol-free antimicrobial mouthrinses were found to be more effective in reducing plaque (measured by QHI and MPPI) compared to toothbrushing alone, demonstrating the added benefit of rinsing.

There was no significant difference in effectiveness between the alcohol-free rinses and the alcohol-containing rinse, suggesting that alcohol-free options can be just as effective for oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on the efficacy of new alcohol-free chlorhexidine mouthrinses after 8 weeks. Zimmer, S., Korte, P., Verde, P., et al.[2015]

Therapeutic mouthrinses can effectively complement mechanical tooth cleaning by directly killing harmful oral bacteria or preventing their adhesion, which helps manage oral biofilms.

These mouthrinses are important for both treating and preventing gum disease, thereby supporting overall oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plaque inhibition: the science and application of oral rinses. Demke, R.[2012]

Cepacol mouthrinse demonstrated the lowest minimum inhibitory concentration (MIC) and minimal bactericidal concentration (MBC) against Streptococcus mutans, indicating it is highly effective at killing this bacteria compared to other mouthrinses tested.

Both Noplak and Cepacol significantly reduced enamel demineralization and lesion depth, suggesting they have the best anti-caries effects among the mouthrinses evaluated in this study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of oral antimicrobial mouthrinses containing alcohol on viability of Streptococcus mutans and microcosm biofilm and on the prevention of enamel caries lesions. Braga, AS., Degand, GB., Pires, JG., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Antiseptic mouth rinses: an update on comparative effectiveness, risks and recommendations. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Expanded and future uses of mouthrinses. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of 6 months use of an antiseptic mouthrinse on supragingival dental plaque microflora. [2019]

4. Iran pubmed.ncbi.nlm.nih.gov

Comparison of Antimicrobial Effects of Three Different Mouthwashes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of an antiseptic mouthrinse on salivary microbiota. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of two mouthrinses in relation to salivary flow and perceived dryness. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Reduction of viable bacteria in dental aerosols by preprocedural rinsing with an antiseptic mouthrinse. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Antiseptic effect of a novel alcohol-free mouthwash: a convenient prophylactic alternative for high-risk patients. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on the efficacy of new alcohol-free chlorhexidine mouthrinses after 8 weeks. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Plaque inhibition: the science and application of oral rinses. [2012]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of oral antimicrobial mouthrinses containing alcohol on viability of Streptococcus mutans and microcosm biofilm and on the prevention of enamel caries lesions. [2019]