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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crest Daily Whitening Serum | Other | one week's use of Crest Daily Whitening Serum as described on the label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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
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| Name | Affiliation | Role |
|---|---|---|
| Mabi Singh, DMD,MS | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3476596 | 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. | |
| 21029258 | 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. |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| 20572857 | 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. |
| 16829502 | 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. |
| 15934347 | 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. |
| 12555958 | 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. |
| 28741683 | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |