Duration of Effect of Biotene Spray in Patients With Dry Mouth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03663231|
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dry Mouth||Device: Biotene Device: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth|
|Actual Study Start Date :||February 11, 2019|
|Actual Primary Completion Date :||November 22, 2019|
|Actual Study Completion Date :||November 22, 2019|
People who present with dry mouth and will receive a single dose of Biotene.
Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL.
Placebo Comparator: Placebo
People who present with dry mouth and will receive a single dose of an alternative agent.
IND/IDE exempt device primarily water
- mean duration of action of intervention [ Time Frame: baseline up to 2 hours ]Participant will receive a dose of Biotene and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action.
- mean subject evaluation of test reagent [ Time Frame: 2 hours ]Subjects will be given a 10 question survey that assesses their tolerability, acceptability, and ease of use of product. The range of the questionnaire score is 1-30 with 30 indicating better outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663231
|United States, New York|
|University of Rochester Eastman Dental Center|
|Rochester, New York, United States, 14620|