Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis

NCT ID: NCT06194123

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Xerostomia Halitosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Crest Daily Whitening Serum

Intervention Type OTHER

one week's use of Crest Daily Whitening Serum as described on the label.

Interventions

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Crest Daily Whitening Serum

one week's use of Crest Daily Whitening Serum as described on the label.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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

Exclusion Criteria

i. 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.

iv. Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome per the investigator's expert opinion.

v. 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.

vi. Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.

vii. Subjects currently participating in any other research studies. viii. Subject unable to provide consent (e.g. Cognitively impaired adults). ix. Non-English speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mabi Singh, DMD,MS

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Locations

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Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 3476596 (View on PubMed)

Osailan 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.

Reference Type BACKGROUND
PMID: 21029258 (View on PubMed)

Pramanik 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.

Reference Type BACKGROUND
PMID: 20572857 (View on PubMed)

Murray 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.

Reference Type BACKGROUND
PMID: 16829502 (View on PubMed)

Thomson 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.

Reference Type BACKGROUND
PMID: 15934347 (View on PubMed)

Guggenheimer 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.

Reference Type BACKGROUND
PMID: 12555958 (View on PubMed)

Apperley 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.

Reference Type BACKGROUND
PMID: 28741683 (View on PubMed)

Other Identifiers

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4475

Identifier Type: -

Identifier Source: org_study_id

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