Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis

Xerostomia Clinical Trial

Official title:

Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194123
• Other study ID #: 4475
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2024
• Source: Tufts University
• Contact: Mabi Singh, DMD, MS
• Phone: 617-636-3931
• Email: dentalresearchadministration[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Halitosis
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5, 30, 60 minute post application of product as well as degree of change after a 7 day period of use.
Secondary	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	60 minutes post application as well as degree of change after a 7 day period of use.