Arginine Toothpaste for Dry Mouth

Overseen By Ann-Marie Billig

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tufts University

Must be taking: Xerostomia medications

Must not be taking: Antibiotics, Antimicrobials, Pilocarpine, others

Disqualifiers: Sjogren's, Sarcoidosis, Immunocompromised, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special toothpaste with arginine to determine its effectiveness for people with dry mouth, a condition characterized by insufficient saliva production. Participants will use either the arginine toothpaste (Tom's of Maine Rapid Relief toothpaste) or a regular fluoride toothpaste (Colgate Cavity Protection Fluoride Toothpaste) for three months to compare effects. It is ideal for those experiencing dry mouth due to taking at least two medications known to cause this side effect. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for dry mouth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to have been taking at least two medications that cause dry mouth for the last three months, so it seems you may continue with those medications.

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

Research has shown that arginine toothpaste is usually easy for people to use. In studies, users of arginine toothpaste reported only mild side effects, indicating its safety for most individuals.

Tom's of Maine Rapid Relief toothpaste, which also contains arginine, is known for its gentle nature. Designed for sensitive teeth, it uses natural ingredients and avoids harsh chemicals or artificial additives, which can reassure those worried about side effects.

Overall, evidence suggests that toothpastes with arginine are safe, with rare and mild side effects. This makes them a good option for people with dry mouth or sensitive teeth. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dry mouth?

Unlike traditional treatments for dry mouth, which typically focus on moisturizing the mouth or stimulating saliva production, the investigational toothpaste being studied contains 8% arginine. Arginine is an amino acid that may help enhance oral health by potentially neutralizing acids produced by bacteria in the mouth and improving the overall oral environment. This makes the toothpaste a promising option for not only relieving dry mouth but also for providing additional dental benefits, such as protecting against cavities, which are common concerns for those with dry mouth. Researchers are excited about this because it could offer a dual approach to oral care in one product.

What evidence suggests that this trial's treatments could be effective for dry mouth?

This trial will compare the effectiveness of an 8% Arginine toothpaste with a control toothpaste containing 1000 ppm fluoride. Research has shown that toothpaste with 1.5% arginine and fluoride prevents cavities more effectively than regular fluoride toothpaste. Arginine neutralizes acids in the mouth, protecting teeth from decay, and boosts saliva production, aiding those with dry mouth. Tom's of Maine Rapid Relief toothpaste, which contains arginine, quickly eases tooth sensitivity by blocking pain signals. Overall, toothpaste with arginine may improve oral health by reducing cavities and relieving dry mouth symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Athena Papas, DMD, PhD

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for men and women with dry mouth who meet specific health requirements. Participants will be using one of two toothpastes over three months to see if there's an improvement in their oral condition.

Inclusion Criteria

I rate my dryness severity at 4 or higher on a scale of 0 to 10.

I have been on two medications causing dry mouth for the last three months.

Minimum of 10 teeth

Exclusion Criteria

Subjects unable to understand or unwilling to sign the informed consent form

Participation in any other clinical study within 1 week prior to enrollment into this study

I am not taking new or higher doses of pilocarpine or similar medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a 1000 ppm F toothpaste or an 8% Arginine toothpaste for 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in salivary pH and oral microbiome after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Colgate Cavity Protection Fluoride Toothpaste
• Tom's of Maine Rapid Relief toothpaste

Trial Overview The study compares Colgate Cavity Protection Fluoride Toothpaste with Tom's of Maine Rapid Relief toothpaste, both containing arginine, to see which is better for dry mouth over a period of three months.

How Is the Trial Designed?

Group I: Investigative Arm- Using an 8% Arginine toothpaste Experimental Treatment 1 Intervention

For the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste.

Group II: Control Arm- a 1000 ppm F toothpaste Active Control 1 Intervention

For the study period (12 weeks), subjects in the Control Arm will be instructed to brush their teeth with Control Arm- a 1000 ppm F toothpaste.

Colgate Cavity Protection Fluoride Toothpaste is already approved in United States, India, European Union for the following indications:

Approved in United States as Colgate Cavity Protection Fluoride Toothpaste for:

• Prevention of dental caries
• Relief of dentin hypersensitivity

Approved in India as Colgate Strong Teeth Toothpaste for:

• Prevention of dental caries
• Relief of dentin hypersensitivity
• Nourishment of teeth

Approved in European Union as Colgate Cavity Protection Fluoride Toothpaste for:

• Prevention of dental caries
• Relief of dentin hypersensitivity

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Colgate Palmolive

Industry Sponsor

Trials

106

Recruited

19,100+

Noel Wallace

Colgate Palmolive

Chief Executive Officer since 2019

MBA from Harvard Business School

Diana Haussling

Colgate Palmolive

Chief Marketing Officer since 2022

Bachelor's degree in Marketing

Published Research Related to This Trial

The Colgate-Palmolive Company has conducted a clinical program to evaluate the benefits of adding 1.5% arginine to fluoride toothpaste.

This addition aims to enhance the effectiveness of fluoride in preventing dental issues, although specific results or outcomes from the clinical program are not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comment on the paper entitled 'Arginine and caries prevention: A systematic review'. [2018]

A novel toothpaste containing 1.5% arginine, an insoluble calcium compound, and fluoride has been shown to significantly reduce the risk of dental caries compared to traditional fluoride-only toothpaste, based on results from ten randomized clinical trials (RCTs).

This arginine-containing toothpaste not only enhances caries prevention but also supports the natural oral flora, promoting a healthier oral environment while providing a new approach to supplement mechanical plaque control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Superior Anti-caries Efficacy of Fluoride Toothpaste Containing 1.5% Arginine. Cummins, D.[2018]

A toothpaste with 8.0% arginine and calcium carbonate (Pro-Argin technology) has been clinically validated to provide superior relief from dentin hypersensitivity compared to potassium-based desensitizing toothpastes.

New clinical data shows that this arginine-based toothpaste offers better instant and lasting relief than a toothpaste containing 8% strontium acetate, highlighting its effectiveness in treating sensitive teeth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evidence for the superior efficacy of a dentifrice containing 8.0% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity. Cummins, D.[2014]

Fluoride toothpastes are widely used to prevent cavities, but newer products are now competing by offering additional benefits like anti-tartar and whitening effects.

Recent advancements include multi-benefit toothpastes, such as Crest Gum Care and Colgate Total, which have been clinically shown to reduce plaque and gingivitis, in addition to their cavity-fighting properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The new toothpastes. Mandel, ID.[2010]

A toothpaste containing 8.0% arginine and calcium carbonate (Pro-Argin technology) has been shown to provide superior immediate and lasting relief from dentin hypersensitivity compared to a strontium-based toothpaste.

Clinical studies indicate that the strontium-based toothpaste is not more effective than regular fluoride toothpaste for immediate sensitivity relief, highlighting the efficacy of the arginine-based formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the clinical management of dentin hypersensitivity: a review of recent evidence for the efficacy of dentifrices in providing instant and lasting relief. Cummins, D.[2013]

In an 8-week clinical study with 121 participants, a new Pro-Argin formula toothpaste significantly reduced dentin hypersensitivity compared to a negative control toothpaste, showing improvements in sensitivity to both tactile and air blast stimuli.

The new toothpaste's effectiveness was comparable to that of a commercial Pro-Argin formula toothpaste, indicating that it is a viable option for managing dentin hypersensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dentin hypersensitivity reduction of a new toothpaste containing 8.0% arginine and 1450 ppm fluoride: an 8-week clinical study on Chinese adults. Que, K., Fu, Y., Lin, L., et al.[2013]

A systematic review of 14 randomized controlled trials indicates that arginine-containing toothpastes significantly reduce dentin hypersensitivity compared to placebo and potassium salt-containing toothpastes, with a moderate quality of evidence.

While arginine toothpastes show promise, the evidence quality is lower when compared to strontium-containing toothpastes, highlighting the need for more rigorous studies to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arginine-containing toothpastes for dentin hypersensitivity: systematic review and meta-analysis. Yan, B., Yi, J., Li, Y., et al.[2021]

Colgate Total Pharma (CTP) demonstrated a significant antiplaque effect compared to Colgate Regular Toothpaste (CRT) in a study involving 15 subjects, indicating its potential as an effective oral hygiene product.

The study utilized a robust clinical methodology, including a crossover design and multiple independent examiners, to ensure reliable and reproducible results, confirming the efficacy of CTP in reducing plaque formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the Modified Gingival Margin Plaque Index (MGMPI) method to investigate the inhibitory effect of various toothpastes on dental plaque formation. Moazzez, R., Booth, V., Barnes, VM., et al.[2013]

The 5% NovaMin-based toothpaste was significantly more effective at occluding dentin tubules compared to both water and a control toothpaste after four days of use, indicating its superior efficacy in a clinical setting.

The 8% arginine-based toothpaste did not show significant occlusion compared to the control and water, suggesting it may be less effective under acidic dietary conditions, highlighting the importance of choosing the right desensitizing technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized in situ clinical study comparing the ability of two new desensitizing toothpaste technologies to occlude patent dentin tubules. West, NX., Macdonald, EL., Jones, SB., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-3-xerostomia-5-2024-4df79

Arginine Toothpaste for Dry Mouth Research shows that toothpaste containing 1.5% arginine and fluoride is more effective at preventing cavities than regular fluoride toothpaste. Additionally, ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06365047/dry-mouth-toothpaste-study-comparing-two-toothpastes-with-arginine

Dry Mouth Toothpaste Study - Comparing Two ... This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste.

3. tomsofmaine.com tomsofmaine.com/products/fluoride-free-rapid-relief-sensitive-fresh-mint-toothpaste?srsltid=AfmBOorxkkOSunWgXbwHyvNcycKHKD9c0vBWXSTg2eVhFp-aFrzRg2AD

Rapid Relief Sensitive Fluoride-Free Toothpaste Tom's of Maine Rapid Relief for sensitive teeth goes to work by actually blocking the pathways to sensitive tooth nerves.

4. tomsofmaine.com tomsofmaine.com/products/fluoride-free-rapid-relief-sensitive-fresh-mint-toothpaste?bvstate=pg:2/ct:r&srsltid=AfmBOorDgLd-wLvoWVUZn_dgIY9I90l1bPXtR6KBRpu4GYO280XIlJLM

Rapid Relief Sensitive Fluoride-Free Toothpaste It advertised "rapid relief" of sensitivity, that feeling of slight nerve pain on some tooth surfaces and a little bit of bloody gums. After a few day's use, ...

5. sddental.org sddental.org/docs/statesdsouthdakotalibraries/annual-session/annual-session-handouts/drug-related-problems-handout-5-17-25.pdf?sfvrsn=b84864da_1

USEFUL DRUG & DENTAL MANAGEMENT ... NeutraSal is indicated for dryness of the mouth (hyposalivation, xerostomia); NeutraSal is also indicated for dryness of the oral mucosa due to drugs such as ...

6. tomsofmaine.com tomsofmaine.com/products/fluoride-free-rapid-relief-sensitive-fresh-mint-toothpaste?srsltid=AfmBOoqntsxsWprWABQmJuzDZl33xE2R-3FpjfM-z2WdMxOh3Zab6836

Rapid Relief Sensitive Fluoride-Free Toothpaste Soothe sensitive teeth naturally! Tom's of Maine Rapid Relief Sensitive Fluoride-Free Toothpaste provides gentle care with naturally derived ingredients.

7. ewg.org ewg.org/skindeep/products/1055474-Toms_of_Maine_Fluoride_Free_Rapid_Relief_Sensitive_Fresh_Mint_Toothpaste/

EWG Skin Deep® | Tom's of Maine Fluoride Free Rapid ... EWG's Skin Deep® Cosmetics Database Rating for Tom's of Maine Fluoride Free Rapid Relief Sensitive Fresh Mint Toothpaste.

8. geriatrichousecalldentistry.com geriatrichousecalldentistry.com/product/toms-of-maine-fluoride-free-rapid-relief-sensitive-toothpaste-fresh-mint-4-oz-3-pack-packaging-may-vary/

Tom's of Maine Fluoride-Free Rapid Relief Sensitive ... Best of all, it contains no animal ingredients, preservatives, or artificial flavors or colors, and is not tested on animals.

9. tomsofmaine.ca tomsofmaine.ca/en-ca/products/oral-care/rapid-relief-sensitive-toothpaste

Rapid Relief Sensitive Fluoride Free Natural Toothpaste ... With regular use, this natural toothpaste builds a protective barrier that acts like a seal against sensitivity. It is a fluoride free toothpaste for sensitive ...