Blinded Dry Mouth Spray Crossover Study
- Conditions
- Interventions
- Registration Number
- NCT04608773
- Lead Sponsor
- Jonas Johnson
- Brief Summary
To identify the effectiveness of two mouth sprays at relieving symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.
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- Detailed Description
Investigators have observed that patients at the University of Pittsburgh Medical Center Head and Neck Survivorship clinic with symptoms of radiation-induced xerostomia expressed verbal preference for Biotene and Refresh mouth sprays (spray form of mouthwash) compared to other oral products such as gel, toothpaste, and chewing gum. Investigators have designe...
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- biopsy-proven oral cavity, oropharynx, larynx, and hypopharynx carcinoma
- who received primary radiation with curative intent (>50 Gray in 20 fractions)
- radiation treatment completed greater than 6 months ago
- who endorse xerostomia
- evidence of metastasis or recurrent disease
- Current use of pilocarpine, antidepressants, anticholinergic drugs, or any other medication that has an effect on salivation
- those who have documented medical conditions associated with xerostomia such as Sjogren's Syndrome
- those who use oral inhalants for the treatment of respiratory disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Biotene Spray, followed by Refresh Spray Remineralizing Extreme Dry Mouth Spray with Xylitol The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed) Refresh Spray, followed by Biotene Spray Remineralizing Extreme Dry Mouth Spray with Xylitol The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed) Biotene Spray, followed by Refresh Spray Alcohol-Free Moisturizing Dry Mouth Spray The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed) Refresh Spray, followed by Biotene Spray Alcohol-Free Moisturizing Dry Mouth Spray The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)
- Primary Outcome Measures
Name Time Method Oral Dryness 2 week trial period at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics.
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- Secondary Outcome Measures
Name Time Method Speaking Difficulty Due to Oral Dryness 2 week trial Speaking difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Speaking difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to speak without drinking liquids? Very Difficult 0 10 20 30 40 50 60 70 80 9...
Sleeping Difficulty Due to Oral Dryness 2 week trial sleeping difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Sleeping difficulty will be measured on a 0-100 point scale
...Taste Alteration/Impairment Due to Oral Dryness 2 week trial Alteration/impairment in sense of taste will be documented via questionnaire completion by participants administered via Qualtrics. Taste alteration/impairment will be measured on a 0-100 point scale "During the last three days, has your sense of taste been impaired or affected? Greatly Impaired/Affected 0 10 20 30 40 50 60 70 80 90 100 Not Impaired/Affected...
Swallowing and Chewing Difficulty Due to Oral Dryness 2 week trial Swallowing and chewing difficulty due to oral dryness will be documented via questionnaire completion by participants administered via Qualtrics. Swallowing and chewing difficulty will be measured on a 0-100 point scale "During the last three days, overall, due to the dryness of your mouth and tongue, how difficult was it to chew and swallow food? Very Diffi...
Saliva PH 2 week trial PH Is a measure of acidity on a logarithmic scale range 0 (most acidic) to 14 (most basic) with a neutral PH of 7 as the desired outcome.
Difficulty Wearing Dental Prostheses (if Applicable) 6 weeks Difficulty wearing dental prostheses (if applicable) will be documented via questionnaire completion by participants administered via Qualtrics. Dental prostheses wearing difficulty will be measured on a 0-100 point scale "If you normally wear dentures, due to the dryness of your mouth and tongue, how difficult was it to wear dentures during the last three d...
Trial Locations
- Locations (2)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States