Exploratory Study on Effect of Whitening Agent With Emulsion Gel in Xerostomic Population

NCT04996069 | Completed Results

• 1 other identifier: STUDY00001757
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Xerostomia, is a subjective sensation of dryness of the mouth. There are more than 700 medications that can lead to the salivary hypofunction that results in dry mouth. This study will investigate a semi solid cohesive gel (referred to as Whitening Gel) that has the primary marketed purpose of teeth whitening. We theorize that the whitening gel's retention in the oral cavity is longer than rinse forms and this is likely to promote the flow of saliva by stimulating taste buds which could alleviate the sensation of dryness in the oral cavity. This will be a single center, two visit study investigating the effectiveness of dryness in the oral cavity, whiteness of teeth, and teeth sensitivity after one week's use of whitening agent.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• Subjective Perception of Mouth Dryness

  At both study visits, subjects will be asked to complete a visual analog scale (VAS) before and after the application of the study product to establish a self-reported subjective perception of the oral cavity. The scale ranges from 0 to 10 and the higher the score indicates the more Xerostomic the subject.

  visit 1 and visit 2 pre and post product application on Day 1 and day 7

Secondary Outcomes (2)

• Change in Saliva Production Measured in ml/Min

  visit 1 and visit 2 pre and post saliva production in day 1 and day 7

• Perceived Sensitivity of Teeth Between Visit 1 and 2

  7 days between visit 1 and visit 2

Study Arms (1)

All Participants

EXPERIMENTAL

This is a single arm study. All subjects enrolled will be apart of the experimental group. Subjects in this group will use Crest Whitening Emulsions on their teeth up to 4 times a day for 7 days in order for the study team to evaluate if the study intervention product increases saliva production in this Xerostomic population.

Device: Crest Whitening Emulsions

Interventions

Crest Whitening Emulsions DEVICE

Subjects with Xerostomia will be asked to apply the study intervention product to their teeth up to 4 times per day for 1 week to investigate if the study intervention product increases saliva production in this dry mouth populaiton.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• The inability to produce more than 0.18mL/min of unstimulated saliva.
• Score of 5 or more in the VAS dry mouth scale, evaluated in the mouth feel questionnaire.
• Evidence of currently taking Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines.
• Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne or Pronamel.
• Subject willing to comply with the study regimen and products.

You may not qualify if:

• Subjects who are currently pregnant (self-reported).
• Subjects able to produce more than 0.18mL/min of unstimulated saliva
• 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.
• Subjects with a condition the investigator believes not suitable for the study such as autoimmune diseases 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.
• Subject unable to provide consent (ex. Cognitively impaired adults).
• 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)

• 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

• 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

• 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

• 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

• 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

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Mabi Singh
• Organization: Tufts University School of Dental Medicine

mabi_l.singh@tufts.edu

6176363931

Study Officials

• Mabi Singh, DMD, MS

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This will be an open label study; thus no randomization plan is necessary.There will be no blinding for this study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Diagnostic Sciences

Model Details: * Primary aim: To see a reduction in the self-reported subjective perception of dryness in the oral cavity. * Secondary aims: To measure self-reported sensitivity of the teeth, self-reported perception of teeth whiteness, and objective measurement of improvement of saliva production.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 9, 2021
• Study Start: August 9, 2021
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)