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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of OTC oral care products for oral health?

Research shows that fluoride in mouthwashes can help prevent cavities, especially in people at high risk, and certain mouthwashes can relieve dry mouth symptoms. These findings suggest that OTC oral care products like toothpaste and mouthwash may be effective in improving oral health. ^{1 2 3 4 5}

Are OTC oral care products like toothpastes and mouthwashes safe for humans?

Some ingredients in toothpastes and mouthwashes can cause allergic reactions or irritation in the mouth, such as stomatitis (inflammation of the mouth) and dermatitis (skin irritation). Common allergens include flavors like cinnamon and mint, and preservatives. Additionally, the antiseptic triclosan in some products may have harmful effects. ^{6 7 8 9 10}

How do OTC oral care products differ from other treatments for oral health?

OTC oral care products like toothpastes and mouthrinses are unique because they are easily accessible and can contain a variety of ingredients such as fluoride, triclosan, and mineral salts, which help improve oral health by reducing bacteria and strengthening teeth. Unlike prescription treatments, these products are available without a prescription and can offer multiple benefits, including antimicrobial action and cosmetic improvements. ^{1 6 11 12 13}

What is the purpose of this trial?

The purpose of this research study is to develop a better way of measuring the health of patients' mouth using photographs and imaging software. The investigators will also study the specific effects of individual toothpastes and mouthwashes on oral health. Participants who have volunteered to be in the study will be asked to use a toothpaste or over a period of 7 days to 6 months. The investigators will determine the participants' oral plaque levels, gum health, and saliva (spit) production with clinical exams as well as photographs of the participants' mouths. It is the hope of the study team to find better ways of assessing the health of patients' mouths and to identify whether gum health can be improved by specific toothpastes or mouthwashes.

Research Team

Petra Wilder-Smith, DDS, PhD

Principal Investigator

Beckman Laser Institute University of California Irvine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical and antimicrobial evaluation of a mouthwash and toothpaste for xerostomia: a randomized, double-blind, crossover study. [2022]

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

Subjective assessment of a new moisturizing mouthwash for the symptomatic management of dry mouth. [2006]

3. India pubmed.ncbi.nlm.nih.gov

The Mouthwash War - Chlorhexidine vs. Herbal Mouth Rinses: A Meta-Analysis. [2022]

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

Practice implications with an alcohol-free, 0.07% cetylpyridinium chloride mouthrinse. [2013]

5. England 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. [2018]

6. Iran pubmed.ncbi.nlm.nih.gov

Cytotoxicity of the Ingredients of Commonly Used Toothpastes and Mouthwashes on Human Gingival Fibroblasts. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Contact allergens in toothpastes and a review of their hypersensitivity. [2019]

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

Allergic contact stomatitis due to desensitizing toothpastes. [2022]

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

Quantification of l-carvone in toothpastes available on the Swedish market. [2019]

10. India pubmed.ncbi.nlm.nih.gov

Triclosan: Hazards of Overuse are not limited to Antibiotics. [2019]

11. Italy pubmed.ncbi.nlm.nih.gov

Chemical vs. natural toothpaste: which formulas for which properties? A scoping review. [2022]

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

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

13. England pubmed.ncbi.nlm.nih.gov

Mouthwashes: Alternatives and Future Directions. [2023]