Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis

NCT06194123 | Active Not Recruiting

• 1 other identifier: 4475
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Xerostomia; Halitosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective 2- Visual Analogue Scale for Perceived Bad Breath and Saliva Production Increase

  60 minutes post application as well as degree of change after a 7 day period of use.

Study Arms (1)

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.

Other: Crest Daily Whitening Serum

Interventions

Crest Daily Whitening Serum OTHER

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (7)

• 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.

  PMID: 3476596 BACKGROUND

• 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.

  PMID: 21029258 BACKGROUND

• 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.

  PMID: 20572857 BACKGROUND

• 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.

  PMID: 16829502 BACKGROUND

• 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.

  PMID: 15934347 BACKGROUND

• 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.

  PMID: 12555958 BACKGROUND

• 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.

  PMID: 28741683 BACKGROUND

MeSH Terms

Conditions

Xerostomia; Halitosis

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mabi Singh, DMD,MS

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 8, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)