OTC Oral Care Products for Oral Health

Overseen By Nicole Wakida, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Allergy to oral hygiene products

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 7 days to 6 months

275 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find better ways to measure oral health using photos and imaging software. Participants will use different toothpastes or mouthwashes (over-the-counter oral care products) to assess their impact on plaque levels, gum health, and saliva production. Individuals with healthy gums who often struggle with plaque buildup might be a good fit for this study.

As an unphased trial, this study offers a unique opportunity to contribute to advancements in oral health measurement techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the dental gels and mouthwashes in this trial are generally safe for use. LivFresh and LivFree Dental Gels have been used in other studies without major issues, helping to reduce plaque and improve gum health. AIM Dental Gel also demonstrated good results in controlling plaque and reducing gum inflammation without causing significant problems.

Crest Prohealth Dental Gel protects against cavities and gum disease and has been used safely by many. Parodontax Dental Gel effectively reduces bacteria that cause bleeding gums and is considered safe when used as directed.

Colgate Total Dental Gel is FDA-approved for fighting bacteria that cause gum issues and is safe for daily use. Lastly, mouthwashes like Lumineux and Listerine have undergone safety testing. Lumineux is alcohol-free, and both help reduce gum inflammation without harmful effects.

Overall, these products are widely used and have been tested in various studies. They are typically well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these oral care products because they offer a variety of options that could enhance oral health in unique ways. Unlike traditional toothpastes, LivFresh and LivFree Dental Gels, along with AIM, Crest Prohealth, Parodontax, and Colgate Total Dental Gels, may provide different active ingredients or formulations aimed at reducing plaque and gingival inflammation more effectively. Additionally, the use of Lumineux or Listerine Mouthwashes in conjunction with brushing could offer an extra layer of protection by tackling bacteria and plaque that brushing alone might miss. These products are being investigated for their potential to improve the efficiency and effectiveness of standard oral hygiene routines, which is why there's so much interest in seeing how they perform in clinical settings.

What evidence suggests that this trial's treatments could be effective for oral health?

This trial will compare various OTC oral care products for oral health. Studies have shown that LivFresh and LivFree Dental Gels, which participants may use, significantly reduce plaque, gum swelling, and bleeding, with improvements of over 200% in these areas. AIM Dental Gel, another option in this trial, effectively controls plaque and reduces gum swelling. Crest Prohealth Dental Gel reduces gum swelling and bleeding, while Parodontax Dental Gel decreases gum swelling and plaque buildup. Colgate Total Dental Gel has demonstrated clear improvements in oral hygiene. Lastly, participants may use Lumineux or Listerine mouthwashes, both of which effectively reduce plaque and gum swelling. ^{1 6 7 8 9}

Who Is on the Research Team?

Petra Wilder-Smith, DDS, PhD

Principal Investigator

Beckman Laser Institute University of California Irvine

Are You a Good Fit for This Trial?

This trial is for adults over 18 in good health who want to help find better ways to measure oral health using images. It's not for those with allergies or intolerances to toothpaste and mouthwash.

Inclusion Criteria

I am in good overall health.

Exclusion Criteria

History of allergy or intolerance of oral hygiene products such as toothpastes and mouthrinses

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use assigned toothpaste or mouthwash for the study duration, with oral health assessments conducted through clinical exams and photographs.

7 days to 6 months

Visits every 1 week, 1 month, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OTC Toothpastes or Mouthrinses

Trial Overview The study tests how well different over-the-counter toothpastes and mouthrinses improve dental plaque control, gum health, and saliva production, using photos and imaging software.

How Is the Trial Designed?

Group I: Brushing with LivFresh Dental Gel Active Control 1 Intervention

Subjects will brush twice daily for the study duration with LivFresh Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

Group II: Brushing with LivFree Dental Gel Active Control 1 Intervention

Subjects will brush twice daily for the study duration with LivFree Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

Group III: Brushing with AIM Dental Gel Active Control 1 Intervention

Subjects will brush twice daily for the study duration with AIM Dental Gels with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

Group IV: Brushing with Crest Prohealth Dental Gel Active Control 1 Intervention

Subjects will brush twice daily for the study duration with Crest Prohealth Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

Group V: Brushing with Parodontax Dental Gel Active Control 1 Intervention

Subjects will brush twice daily for the study duration with Parodontax Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

Group VI: Brushing with Colgate Total Dental Gel Active Control 1 Intervention

Subjects will brush twice daily for the study duration with Colgate Total Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

Group VII: Rinsing with Lumineux or Listerine Mouthwashes Active Control 1 Intervention

Subjects will be asked to rinse twice daily with 1 capful for 1 minute with Lumineux or Listerine Mouthwashes directly after brushing their teeth, while continuing with their usual oral hygiene protocol. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images. These photos will not show the subject's face but will focus on the subject's mouth.

OTC Toothpastes or Mouthrinses is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Toothpaste/Mouthwash for:

• Oral hygiene
• Plaque control
• Gingivitis prevention
• Bad breath prevention

Approved in European Union as Toothpaste/Mouthwash for:

• Oral hygiene
• Plaque control
• Gingivitis prevention
• Bad breath prevention

Approved in Canada as Toothpaste/Mouthwash for:

• Oral hygiene
• Plaque control
• Gingivitis prevention
• Bad breath prevention

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

A scoping review of toothpaste research from 2015 to 2020 found that herbal toothpaste is effective and safe, exhibiting antimicrobial, anti-inflammatory, and desensitizing properties.

Conversely, toothpaste containing sodium lauryl sulfate has been identified as harmful, highlighting the need for clear labeling of active and potentially harmful ingredients on toothpaste packaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical vs. natural toothpaste: which formulas for which properties? A scoping review. Kanouté, A., Dieng, SN., Diop, M., et al.[2022]

A survey of 48 toothpaste products sold in Finland revealed that nearly 50% contained around 30 known allergens, raising safety concerns for users.

Common allergens identified include flavors like cinnamic aldehyde and peppermint, as well as preservatives, which can lead to various oral health issues such as stomatitis and gingivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact allergens in toothpastes and a review of their hypersensitivity. Sainio, EL., Kanerva, L.[2019]

Three cases of allergic contact stomatitis were identified as a result of using desensitizing toothpastes containing stannous chloride, highlighting a potential safety concern.

The study emphasizes the need for dental professionals to be more aware of the adverse effects associated with various toothpaste ingredients, particularly in patients using desensitizing formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic contact stomatitis due to desensitizing toothpastes. He, W., Hu, X., Hua, H., et al.[2022]

A study of 66 commercially available toothpastes in Sweden found that 64 contained l-carvone, a common mint flavor, with concentrations ranging from 0.00005% to 0.35%, and 10 of these exceeded 0.1%.

The presence of l-carvone was often associated with the labeling of limonene, but the concentrations found may not be directly related to the advertised flavor, raising concerns about potential allergic reactions in sensitive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of l-carvone in toothpastes available on the Swedish market. Kroona, L., Warfvinge, G., Isaksson, M., et al.[2019]

In a 6-month study involving 273 healthy adult participants, the 0.07% cetylpyridinium chloride (CPC) therapeutic mouthrinse demonstrated high compliance and favorable user acceptability, indicating it could be effectively integrated into dental care routines.

The therapeutic mouthrinse showed similar side effects to a cosmetic rinse, with no significant differences in calculus or stain accumulation, suggesting it is a safe alternative for maintaining oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice implications with an alcohol-free, 0.07% cetylpyridinium chloride mouthrinse. Blenman, TV., Morrison, KL., Tsau, GJ., et al.[2013]

Toothpastes have evolved from basic cleaning agents to multifunctional products that provide therapeutic benefits, such as fighting cavities and controlling tartar, with the first fluoridated toothpaste introduced in 1955 and tartar-control toothpaste in the mid-1980s.

Research over the past 30 years has focused on enhancing the health and aesthetic benefits of dentifrices, particularly in the multibenefit segment, which is the most popular among consumers in the US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel dentifrice technology for advanced oral health protection: A review of technical and clinical data. Baig, A., He, T.[2015]

In a randomized clinical trial with 49 participants, OASIS Moisturizing Mouthwash significantly improved symptoms of dry mouth compared to normal remedies, showing benefits in flavor, breath freshening, and lubrication.

A consumer usage test with 323 subjects revealed that over 80% rated the mouthwash as 'excellent' or 'very good' for taste and texture, indicating high acceptability and satisfaction among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective assessment of a new moisturizing mouthwash for the symptomatic management of dry mouth. Shirodaria, S., Kilbourn, T., Butler, A., et al.[2006]

A study involving 30 patients with dry mouth showed that a toothpaste and mouthwash containing triclosan, fluoride, and mineral salts significantly improved symptoms of xerostomia, enhancing overall quality of life.

The tested products demonstrated superior antimicrobial action against cariogenic bacteria compared to control products, although they did not show significant differences in effectiveness compared to traditional salivary enzyme substitutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and antimicrobial evaluation of a mouthwash and toothpaste for xerostomia: a randomized, double-blind, crossover study. López-Jornet, MP., García-Teresa, G., Viñas, M., et al.[2022]

A meta-analysis of 11 randomized control studies found that chlorhexidine mouthwash is favored over herbal mouthwashes for oral health, with four studies supporting chlorhexidine and only two supporting herbal alternatives.

The study highlights the need for more rigorous research to validate the efficacy of herbal mouthwashes, as their current evidence does not support them as a replacement for the established 'gold standard' chlorhexidine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mouthwash War - Chlorhexidine vs. Herbal Mouth Rinses: A Meta-Analysis. Manipal, S., Hussain, S., Wadgave, U., et al.[2022]

A study assessing the cytotoxicity of ingredients in 16 toothpastes and 4 mouthwashes found that sodium lauryl sulfate and cocamidopropyl betaine exhibited over 90% cytotoxicity to human gingival fibroblasts, indicating a high risk for oral tissue damage.

The research suggests that to reduce harmful effects, these ingredients should be replaced with safer alternatives, and the concentration of sodium fluoride should be lowered to 400 ppm, or replaced with other safer antibacterial agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytotoxicity of the Ingredients of Commonly Used Toothpastes and Mouthwashes on Human Gingival Fibroblasts. Tabatabaei, MH., Mahounak, FS., Asgari, N., et al.[2022]

Fluoride mouthwashes can be beneficial for children at high risk of dental caries and may also help older adults, especially those prone to root caries, but toothpaste is often more acceptable for children.

The effectiveness of mouthwashes for reducing bad breath (antihalitosis) is unclear, while their anticaries benefits, particularly through fluoride, are significant for individuals with dry mouth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mouthwashes: Do They Work and Should We Use Them? Part 2: Anticaries, Antihalitosis and Dry Mouth Relief Efficacy of Mouthwashes. Hodge, P.[2018]

Some natural mouthwashes, particularly propolis, show promise in reducing plaque and gingivitis, although their overall clinical effectiveness remains debated.

Emerging mouthwash technologies, such as nanoparticle formulations and immunomodulant agents like erythropoietin, could offer targeted treatments for oral conditions like mucositis, but face challenges related to regulatory approval and environmental impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mouthwashes: Alternatives and Future Directions. Duane, B., Yap, T., Neelakantan, P., et al.[2023]

Triclosan, an antiseptic commonly found in toothpastes and mouthrinses, poses potential risks that are not well understood, raising concerns about its safety in routine oral care products.

While much criticism has been directed at alcohol content in mouthrinses, the harmful effects of triclosan on oral health warrant further attention and investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triclosan: Hazards of Overuse are not limited to Antibiotics. Uppal, N., Bonanthaya, K.[2019]

Citations

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Effects of a Novel Dental Gel on Plaque and Gingivitis The novel dental gel formulation was provided effective plaque control and reduced gingival inflammation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524004/

A Randomized Double-Blind Clinical Trial Evaluating ... A new stannous fluoride dental gel toothpaste demonstrated significant improvements in plaque, gingival inflammation and bleeding on probing

3. sciencedirect.com sciencedirect.com/science/article/pii/S0020653924012644

Evaluation of antioxidant properties of gingival gel in ... The muco-gingival gel proved effective in the context of experimental periodontitis in rats. This was evidenced by a reduction in malondialdehyde content.

4. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-025-05551-z

Effectiveness of a novel amine + zinc + fluoride toothpaste in ... For subjects with the most severe inflammation problems (gingival index of 3), more than 70% of sites improved after 6 months, meaning 7 of 10 ...

5. researchgate.net researchgate.net/publication/338074500_Effects_of_a_Dental_Gel_Over_6_Months_on_Periodontal_Health_in_Subjects_with_Stage_II_and_III_Mild_and_Moderate_Periodontitis

(PDF) Effects of a Dental Gel Over 6 Months on Periodontal ... A test dental gel was found to improve gingival inflammation and bleeding, as well as periodontal pocket depths significantly better than a control dentifrice.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5342977/

Plaque Removal and Gingival Health after Use of a Novel ... In this clinical study, a test dental gel demonstrated significantly more effective plaque control and reduced gingival inflammation compared to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06915623

Gels to Treat and Prevent Gingival Inflammation Around ... This study aims to evaluate a gel's potential to improve gum health around dental implants when used alongside traditional cleaning methods.

8. researchgate.net researchgate.net/publication/277958626_Effects_Of_A_Novel_Dental_Gel_On_Plaque_And_Gingivitis_A_Comparative_Study

(PDF) Effects Of A Novel Dental Gel On Plaque And Gingivitis The dental gel was designed to (1) break up and prevent re-accumulation of microbial biofilm, and (2) inhibit metal mediated inflammation.

9. frontiersin.org frontiersin.org/journals/dental-medicine/articles/10.3389/fdmed.2024.1442887/full

Innovations in oral hygiene tools: a mini review on recent ... This review examines advancements in oral hygiene aids and their impact on gingival and periodontal health.