Halitosis, Xerostomia
Conditions
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.
Interventions
OTHERCrest Daily Whitening Serum
one week's use of Crest Daily Whitening Serum as described on the label.
Sponsors
Tufts University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective 1- Visual Analogue Scale for Perceived Dry Mouth | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMabi Singh, DMD,MS
Tufts University School of Dental Medicine
Outcome results
None listed