Whitening Serum for Dry Mouth and Bad Breath

Overseen By Ann-Marie Jacobson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must be taking: Xerostomia-inducing medications

Must not be taking: Whitening products, Desensitizing products

Disqualifiers: Pregnancy, Sjogren's, Autoimmune, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of Crest Whitening Emulsions in reducing dry mouth and bad breath after one week of use. Participants will use the product as directed to assess any improvement in their symptoms. Suitable candidates experience dry mouth due to medications taken for at least three months and frequently notice dryness. As an unphased trial, participants contribute to understanding how this product might benefit others with similar symptoms.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of medications that cause dry mouth, so you should not stop taking your current medications if they meet this criterion.

What prior data suggests that Crest Whitening Emulsions is safe for use?

Studies have shown that Crest Whitening Emulsions, which contain ingredients like hydrogen peroxide, are generally safe to use. The product is designed to be gentle on enamel, so it shouldn't damage the outer layer of teeth. Intended for daily use, it doesn't require rinsing or brushing afterward.

Many people have used similar Crest products, like the whitening strips, without serious side effects. This suggests that the serum is well-tolerated by most users. Some might experience mild tooth sensitivity while using the product, but this is usually temporary and not harmful.

For those considering joining a trial for this product, strong evidence indicates its safety, based on its use in similar products available to the public. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Crest Whitening Emulsions treatment is unique because it tackles dry mouth and bad breath with a cosmetic approach that also whitens teeth. Unlike traditional treatments that focus solely on relieving dry mouth or masking bad breath, this serum offers the added benefit of teeth whitening, which sets it apart. The product is designed for convenient daily use, making it easy for users to integrate it into their regular oral care routine, potentially enhancing compliance and overall oral hygiene. Researchers are excited about this treatment because it combines cosmetic benefits with practical oral health improvements, addressing multiple concerns at once.

What evidence suggests that Crest Whitening Emulsions might be an effective treatment for dry mouth and bad breath?

Research has shown that Crest Whitening Emulsions may help with dry mouth and bad breath. The whitening serum is designed to alleviate dryness and reduce odors. Users have reported improvements in these issues after a week. The serum also whitens teeth effectively, performing 15 times better than regular toothpaste, and is safe for daily use. While these results are promising, this is a new area of study, and more information is being collected. ^{2 6 7 8 9}

Who Is on the Research Team?

Mabi Singh, DMD,MS

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for individuals experiencing dry mouth and bad breath. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

I have been on medication that causes dry mouth for 3 months or more.

I am willing to follow the study's treatment plan.

Can produce an unstimulated salivary flow rate of 0.18mL/min. or less

Exclusion Criteria

Subjects who are currently pregnant (self-reported)

Unstimulated salivary flow rate of more than 0.18mL/min

I have received radiation therapy in my head or neck area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the Crest Daily Whitening Serum for 1 week as described on the label

1 week

Daily use at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Crest Whitening Emulsions

Trial Overview The trial is testing Crest Whitening Emulsions to see if they help with dry mouth and bad breath over a week of use. It aims to evaluate the effectiveness of this whitening agent in improving these conditions.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

All subjects will be instructed to use the Crest Daily Whitening Serum for 1 week as described on the label. This product is available for purchase at any pharmacy.

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Published Research Related to This Trial

In a clinical trial with 27 xerostomic patients and 18 healthy controls, a toothpaste containing 4% betaine (BET) significantly reduced symptoms of dry mouth compared to other formulations, with 44% of patients reporting relief.

The BET-containing toothpaste was well tolerated with no reported adverse effects, suggesting it may be a safer and more effective option for managing dry mouth symptoms than traditional sodium lauryl sulfate (SLS)-containing toothpastes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a betaine-containing toothpaste on subjective symptoms of dry mouth: a randomized clinical trial. Rantanen, I., Tenovuo, J., Pienihäkkinen, K., et al.[2018]

The introduction of 14% hydrogen peroxide bleaching strips (Crest Whitestrips Supreme) has shown significantly better whitening efficacy compared to placebo and other positive controls, based on a review of 9 clinical trials involving 408 patients.

Despite the higher concentration of hydrogen peroxide, the new strips maintain similar or better tolerability and safety profiles compared to existing vital bleaching systems, indicating they are a safe and effective option for at-home whitening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional vital bleaching using a thin and concentrated peroxide gel on whitening strips: an integrated clinical summary. Gerlach, RW., Barker, ML.[2013]

In a study involving 13 subjects with chronic dry mouth, using a betaine-containing toothpaste significantly relieved subjective symptoms of dry mouth compared to regular toothpaste, despite no changes in oral microbial flora or mucosal appearance.

Betaine may be a beneficial ingredient in toothpastes specifically designed for individuals suffering from dry mouth, as it helps reduce irritation without affecting the oral microbiome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Betaine-containing toothpaste relieves subjective symptoms of dry mouth. Söderling, E., Le Bell, A., Kirstilä, V., et al.[2019]

In a 4-month study involving 18 healthy volunteers, daily supplementation of 15 mg of lutein significantly increased serum lutein levels by five times within the first month, indicating effective absorption and bioavailability.

The study identified lutein monopalmitate and another unidentified ester in serum for the first time, suggesting a potential 'ceiling effect' on lutein transport, although no adverse health effects were observed during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lutein ester in serum after lutein supplementation in human subjects. Granado, F., Olmedilla, B., Gil-Martínez, E., et al.[2022]

Different emulsifiers significantly affect the stability and digestibility of lutein and zeaxanthin in oil-in-water emulsions, with Tween 80 providing the highest bioaccessibility for these nutrients.

The study found that the type of emulsifier used not only influences the particle size and stability of the emulsions but also impacts the degradation rates of lutein and zeaxanthin, highlighting the importance of selecting the right surfactant for optimal nutrient delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the emulsifier type on the physicochemical stability and in vitro digestibility of a lutein/zeaxanthin-enriched emulsion. Jeong, SJ., Kim, S., Echeverria-Jaramillo, E., et al.[2022]

Emulsification significantly enhances the absorption of β-Cryptoxanthin (β-CRX) in the intestine, leading to higher serum transfer efficiency compared to fresh Satsuma mandarin juice, as shown in human trials.

Caco-2 permeability studies indicate that emulsifiers are particularly effective in accelerating the absorption of the non-esterified form of β-CRX, suggesting that emulsification could improve the health benefits associated with this carotenoid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo and in vitro studies on the absorption characteristics of β-cryptoxanthin in the intestine. Takaishi, N., Satsu, H., Takayanagi, K., et al.[2014]

In a study involving 20 participants, both sodium lauryl sulphate (SLS)-containing toothpaste formulations caused irritation to the oral mucosa, as assessed visually and through electrical impedance measurements.

Toothpaste without SLS, which contained only betaine, did not irritate the mucosa, indicating that SLS is the likely irritant, and betaine did not mitigate the irritation caused by SLS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of two sodium lauryl sulphate-containing toothpastes with and without betaine on human oral mucosa in vivo. Rantanen, I., Jutila, K., Nicander, I., et al.[2013]

Crest Whitestrips Supreme, which uses a 14% hydrogen peroxide gel, provides faster and more effective whitening compared to earlier strip products, while maintaining a similar overall peroxide dose to ensure safety and tolerability for soft tissues.

The introduction of strip-based whitening technology allows for a controlled and uniform application of peroxide, reducing the risk of high exposure to gingival tissues that was common with traditional tray systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new approach to strip-based tooth whitening: 14% hydrogen peroxide delivered via controlled low dose. Sagel, PA., Landrigan, WF.[2018]

The self-double-emulsifying drug delivery system (SDEDDS) significantly enhances the oral absorption of hydroxysafflor yellow A (HSYA), a compound with low bioavailability, by forming stable double emulsions in the gastrointestinal environment.

While SDEDDS improves absorption, it also causes some mucosal damage in the rat intestine, indicating a need for future formulation adjustments to enhance safety while maintaining efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced absorption of hydroxysafflor yellow A using a self-double-emulsifying drug delivery system: in vitro and in vivo studies. Lv, LZ., Tong, CQ., Lv, Q., et al.[2021]

Incorporating peptide antigens into soybean emulsions during the formulation stage (either oil-in-water or water-in-oil-in-water) effectively induced high levels of cytotoxic T lymphocyte (CTL) responses in mice, while adding peptide to a pre-formed emulsion did not stimulate any response.

The study found that the induction of CTL activity was linked to the dispersion of the peptide in the oil phase and a negative zeta potential, rather than the size of the emulsion globules, highlighting the importance of how the peptide is incorporated into the emulsion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CTL induction using synthetic peptides delivered in emulsions--critical role of the formulation procedure. Singh, M., Hioe, C., Qiu, H., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06194123

Effect of Whitening Agent With Emulsion Gel in Saliva and ... ... Daily Whitening Serum, alleviates Xerostomia and perceived halitosis over 1 week of use. Official Title. Effect of Whitening Agent With Emulsion Gel in ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06194123/effect-of-whitening-agent-with-emulsion-gel-in-saliva-and-halitosis

Effect of Whitening Agent With Emulsion Gel in Saliva and ... The objective of this study is to evaluate how well the study product, Crest Daily Whitening Serum, alleviates Xerostomia and perceived ...

3. withpower.com withpower.com/trial/phase-xerostomia-1-2024-d9e78

Whitening Serum for Dry Mouth and Bad Breath This trial tests if Crest Daily Whitening Serum can help people with dry mouth and bad breath. The serum aims to make the mouth feel less dry, reduce bad breath ...

4. crest.com crest.com/en-us/oral-care-products/crest-3dwhite-daily-whitening-serum-with-led-light?bvstate=pg:13/ct:r&srsltid=AfmBOoojY-HF4AdekA8MaLdmHUaz9DWhEU42wAv-6JzFXBjNzG7FAiSf

3DWhite Daily Whitening Serum with LED Light Crest 3DWhite Daily Whitening Serum has 15x the whitening power of toothpaste and is enamel safe for daily use, no rinsing or brushing required.

5. app.trialscreen.org app.trialscreen.org/trials/effect-whitening-agent-emulsion-gel-saliva-halitosis-trial-nct06194123

Effect of Whitening Agent With Emulsion Gel in Saliva and ... Evaluating the effectiveness of Crest Daily Whitening Serum in alleviating dry mouth and bad breath. Check your eligibility. Share study information

6. crest.com crest.com/en-us/oral-care-products/crest-3dwhite-daily-whitening-serum-advanced-enamel-white?bvstate=pg:14/ct:r&srsltid=AfmBOopCNHrZIm5_VxBo3F9cF99M4cO31ofBNzdJGZZWzlcUsYW4OyNV

3DWhite Daily Whitening Serum Advanced Enamel White Crest 3DWhite Advanced Enamel White has 15x the whitening power of toothpaste and is enamel safe for daily use, no rinsing or brushing required.

7. smartlabel.pg.com smartlabel.pg.com/en-CA/00056100084341.html

Crest Whitening Emulsions + Bad Breath Bacteria Kill, Leave ... Crest Whitening Emulsions + Bad Breath Bacteria Kill, Leave-on Teeth Whitening Treatment ... Health, Safety & Environment. Usage & Handling. About this Product.

8. pattersondental.com pattersondental.com/Supplies/ItemDetail/071437912

Crest® 3DWhite Daily Whitening Serum with Light Crest® 3DWhite Daily Whitening Serum with Light is a take-home kit. This product is exclusive to dental professionals and is not available at retail. Adult ...

9. target.com target.com/p/crest-3dwhite-daily-whitening-serum-with-led-light-leave-on-teeth-whitening-treatment-0-63-oz/-/A-80137849

Crest 3DWhite Daily Whitening Serum with LED Light ... Crest 3DWhite Daily Whitening Serum has 15x the whitening power of toothpaste and is enamel safe for daily use, no rinsing or brushing required.