A Phase 1 interventional study of sugar-free chewing gum and chewing gum in Xerostomia, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by University of Oklahoma · Phase 1, Interventional, and Treatment
The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.
Xerostomia (dry mouth) is the most common late complication of radiation therapy for head and neck cancers. When patients are cured or survive for several years, xerostomia often becomes quite bothersome; it affects their quality of life. This study compares the effectiveness of seven over-the-counter remedies, 2 rinses, 3 sprays and 2 chewing gums. A computer program will make random assignments so that the patient nor the physician will choose the order in which the products are tried. The remedies will be used for one week each and at the end of each period the patient will fill out a questionaire.
254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.
This study's enrollment of 28 is below the median of 42 across 216 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each participant will receive an unidentified product to use for a one week period. This will continue until all 7 dry-mouth products have been evaluated.
Other: sugar-free chewing gum · Other: chewing gum · Other: mouth rinse · Drug: mouth spray
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Also known as: Freedent chewing gum
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Also known as: Biotene chewing gum
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire
Also known as: Flavored water
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Also known as: Biotene mouth rinse
Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
Also known as: Salivart
Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
Also known as: MouthKote
The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.
Time frame: 8-10 weeks
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of Oklahoma