XerostomiaNCT06194123
Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis
A study testing Crest Daily Whitening Serum in people with Xerostomia and Halitosis, run by Tufts University at 1 site in United States.
Trial summary
The objective of this study is to evaluate how well the study product, Crest Daily Whitening Serum, alleviates Xerostomia and perceived halitosis over 1 week of use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Halitosis
- What is being tested?
- Crest Daily Whitening Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Can produce an unstimulated salivary flow rate of 0.18mL/min. or less.
- Score of 3 or more on question 1 of the VAS dry mouth scale (How severe is your dryness right now?), evaluated in the Pre-Product Use Dry Mouth \& Sensitivity Questionnaire.
- Evidence of currently taking a stable dose (3 months or more) of Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines and etc.
- At screening, participants may present the prescription bottle, a picture of the prescriptions bottle or medical records showing the prescription.
- Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne, Pronamel etc.
Show all 11Show fewer
- Subject willing to comply with the study regimen and products.
- Not consume alcohol for 24 hours prior to their visit.
- Not brush their teeth for 1.5 hours prior to their visit.
- Not have had anything to eat or drink (including chewing gum or eating candy) for 1.5 hours prior to their visit). Water is acceptable to drink up to 1 hour prior to the study visit.
- Not smoke 1.5 hours prior to their visit
Who cannot join
- Subjects who are currently pregnant (self-reported). ii. Unstimulated salivary flow rate of more than 0.18mL/min iii. Subjects that have ever received therapeutic radiation in the head and neck area.
- Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome per the investigator's expert opinion.
- Subjects with a condition the investigator believes not suitable for the study, such as autoimmune diseases and radiation therapy to head and neck region that impact salivary flow.
- Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.
- Subjects currently participating in any other research studies. viii. Subject unable to provide consent (e.g. Cognitively impaired adults). ix. Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
The objective of this study is to evaluate how well the study product, Crest Daily Whitening Serum, alleviates Xerostomia and perceived halitosis over 1 week of use.
- Conditions
- Xerostomia, Halitosis
- Being tested
- Crest Daily Whitening Serum
- Medical subject headings
- Xerostomia, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crest Daily Whitening SerumOther
one week's use of Crest Daily Whitening Serum as described on the label.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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. Receives: Other: Crest Daily Whitening Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective 1- Visual Analogue Scale for Perceived Dry Mouth
To observe presence and degree of reduction in the self-reported subjective perception of dryness in the oral cavity at different time intervals after the application of a Whitening Agent with Emulsion Gel in Xerostomic Population
Measured: 5, 30, 60 minute post application of product as well as degree of change after a 7 day period of use.
Secondary outcomes (1)
Objective 2- Visual Analogue Scale for Perceived Bad Breath and Saliva Production Increase
To measure presence and degree of reduction of self-reported bad breath and subject's objective measurement of how well saliva production improved on a 1-10 scale at different time intervals with a Whitening Agent with Emulsion Gel in Xerostomic Population
Measured: 60 minutes post application as well as degree of change after a 7 day period of use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mabi Singh, DMD,MS, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194123
- Sponsor's protocol ID
- 4475
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collins LM, Dawes C. The surface area of the adult human mouth and thickness of the salivary film covering the teeth and oral mucosa. J Dent Res. 1987 Aug;66(8):1300-2. doi: 10.1177/00220345870660080201.
PubMed 3476596Osailan S, Pramanik R, Shirodaria S, Challacombe SJ, Proctor GB. Investigating the relationship between hyposalivation and mucosal wetness. Oral Dis. 2011 Jan;17(1):109-14. doi: 10.1111/j.1601-0825.2010.01715.x. Epub 2010 Oct 28.
PubMed 21029258Pramanik R, Osailan SM, Challacombe SJ, Urquhart D, Proctor GB. Protein and mucin retention on oral mucosal surfaces in dry mouth patients. Eur J Oral Sci. 2010 Jun;118(3):245-53. doi: 10.1111/j.1600-0722.2010.00728.x.
PubMed 20572857Murray Thomson W, Poulton R, Mark Broadbent J, Al-Kubaisy S. Xerostomia and medications among 32-year-olds. Acta Odontol Scand. 2006 Aug;64(4):249-54. doi: 10.1080/00016350600633243.
PubMed 16829502Thomson WM. Issues in the epidemiological investigation of dry mouth. Gerodontology. 2005 Jun;22(2):65-76. doi: 10.1111/j.1741-2358.2005.00058.x.
PubMed 15934347Guggenheimer J, Moore PA. Xerostomia: etiology, recognition and treatment. J Am Dent Assoc. 2003 Jan;134(1):61-9; quiz 118-9. doi: 10.14219/jada.archive.2003.0018.
PubMed 12555958Apperley O, Medlicott N, Rich A, Hanning S, Huckabee ML. A clinical trial of a novel emulsion for potential use as a saliva substitute in patients with radiation-induced xerostomia. J Oral Rehabil. 2017 Nov;44(11):889-895. doi: 10.1111/joor.12545. Epub 2017 Aug 20.
PubMed 28741683
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis
- ClinicalTrials.gov ID
- NCT06194123
- Acronym / sponsor ID
- 4475
- Conditions
- Xerostomia, Halitosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate how well the study product, Crest Daily Whitening Serum, alleviates Xerostomia and perceived halitosis over 1 week of use.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Crest Daily Whitening SerumAll 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years of age.
- Can produce an unstimulated salivary flow rate of 0.18mL/min. or less.
- Score of 3 or more on question 1 of the VAS dry mouth scale (How severe is your dryness right now?), evaluated in the Pre-Product Use Dry Mouth \& Sensitivity Questionnaire.
- Evidence of currently taking a stable dose (3 months or more) of Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines and etc.
- Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne, Pronamel etc.
Key exclusion criteria (5 listed)
- Subjects who are currently pregnant (self-reported). ii. Unstimulated salivary flow rate of more than 0.18mL/min iii. Subjects that have ever received therapeutic radiation in the head and neck area.
- Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome per the investigator's expert opinion.
- Subjects with a condition the investigator believes not suitable for the study, such as autoimmune diseases and radiation therapy to head and neck region that impact salivary flow.
- Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.
- Subjects currently participating in any other research studies. viii. Subject unable to provide consent (e.g. Cognitively impaired adults). ix. Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crest Daily Whitening Serumone week's use of Crest Daily Whitening Serum as described on the label. | Other | Experimental |
Primary outcome
Objective 1- Visual Analogue Scale for Perceived Dry Mouth
Time frame: 5, 30, 60 minute post application of product as well as degree of change after a 7 day period of use.
To observe presence and degree of reduction in the self-reported subjective perception of dryness in the oral cavity at different time intervals after the application of a Whitening Agent with Emulsion Gel in Xerostomic Population
1 secondary outcome
Objective 2- Visual Analogue Scale for Perceived Bad Breath and Saliva Production Increase
Time frame: 60 minutes post application as well as degree of change after a 7 day period of use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 3476596Collins LM, Dawes C. The surface area of the adult human mouth and thickness of the salivary film covering the teeth and oral mucosa. J Dent Res. 1987 Aug;66(8):1300-2. doi: 10.1177/00220345870660080201.
- Background: PubMed 21029258Osailan S, Pramanik R, Shirodaria S, Challacombe SJ, Proctor GB. Investigating the relationship between hyposalivation and mucosal wetness. Oral Dis. 2011 Jan;17(1):109-14. doi: 10.1111/j.1601-0825.2010.01715.x. Epub 2010 Oct 28.
- Background: PubMed 20572857Pramanik R, Osailan SM, Challacombe SJ, Urquhart D, Proctor GB. Protein and mucin retention on oral mucosal surfaces in dry mouth patients. Eur J Oral Sci. 2010 Jun;118(3):245-53. doi: 10.1111/j.1600-0722.2010.00728.x.
- Background: PubMed 16829502Murray Thomson W, Poulton R, Mark Broadbent J, Al-Kubaisy S. Xerostomia and medications among 32-year-olds. Acta Odontol Scand. 2006 Aug;64(4):249-54. doi: 10.1080/00016350600633243.
- Background: PubMed 15934347Thomson WM. Issues in the epidemiological investigation of dry mouth. Gerodontology. 2005 Jun;22(2):65-76. doi: 10.1111/j.1741-2358.2005.00058.x.
- Background: PubMed 12555958Guggenheimer J, Moore PA. Xerostomia: etiology, recognition and treatment. J Am Dent Assoc. 2003 Jan;134(1):61-9; quiz 118-9. doi: 10.14219/jada.archive.2003.0018.
- Background: PubMed 28741683Apperley O, Medlicott N, Rich A, Hanning S, Huckabee ML. A clinical trial of a novel emulsion for potential use as a saliva substitute in patients with radiation-induced xerostomia. J Oral Rehabil. 2017 Nov;44(11):889-895. doi: 10.1111/joor.12545. Epub 2017 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mabi Singh, DMD,MS principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crest Daily Whitening Serum in people with Xerostomia and Halitosis, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective 1- Visual Analogue Scale for Perceived Dry Mouth (time frame: 5, 30, 60 minute post application of product as well as degree of change after a 7 day period of use.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194123, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.