Whitening Serum for Dry Mouth and Bad Breath

Recruiting in Palo Alto (17 mi)

Overseen by Mabi Singh, DMD,MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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, and whiten teeth.

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 data supports the effectiveness of the treatment Crest Whitening Emulsions, Crest Whitening Emulsions, Crest Daily Whitening Serum for dry mouth and bad breath?

The research on emulsions shows that they can improve the absorption of certain compounds, like β-cryptoxanthin and lutein, which might suggest that similar emulsions in the whitening serum could enhance the delivery and effectiveness of its active ingredients. ^{1 2 3 4 5}

Is the whitening serum safe for use in humans?

The whitening strips containing hydrogen peroxide, like Crest Whitestrips, have been tested in several studies and are generally safe for use, with no significant irritation to oral tissues reported. Additionally, betaine-containing products, which are sometimes used for dry mouth, have shown no adverse effects in studies and are well tolerated. ^{6 7 8 9 10}

Research Team

Mabi Singh, DMD,MS

Principal Investigator

Tufts University School of Dental Medicine

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Crest Whitening Emulsions (Other)

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.

Participant Groups

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+

Susan Pandya

Tufts University

Chief Medical Officer

MD from Tufts University School of Medicine

Kenneth Getz

Tufts University

Chief Executive Officer since 2021

MBA from the J.L. Kellogg Graduate School of Management at Northwestern University, BA from Brandeis University

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. New Zealand 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. [2021]

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

Lutein ester in serum after lutein supplementation in human subjects. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

CTL induction using synthetic peptides delivered in emulsions--critical role of the formulation procedure. [2023]

4. England pubmed.ncbi.nlm.nih.gov

In vivo and in vitro studies on the absorption characteristics of β-cryptoxanthin in the intestine. [2014]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of the emulsifier type on the physicochemical stability and in vitro digestibility of a lutein/zeaxanthin-enriched emulsion. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Effects of a betaine-containing toothpaste on subjective symptoms of dry mouth: a randomized clinical trial. [2018]

7. India pubmed.ncbi.nlm.nih.gov

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

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

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

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

Betaine-containing toothpaste relieves subjective symptoms of dry mouth. [2019]

10. Sweden pubmed.ncbi.nlm.nih.gov

The effects of two sodium lauryl sulphate-containing toothpastes with and without betaine on human oral mucosa in vivo. [2013]