Status:
COMPLETED
Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborating Sponsors:
Sunstar Suisse
Conditions:
Xerostomia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Background. Xerostomia is estimated to affect up to 50% of the adult population and especially the elderly suffer from dry mouth sensation. Our aim was to compare the efficacy of GUM® Hydral® Moisturi...
Detailed Description
After clinical history analysis subjects were randomized, using a stratified randomization list which considered as main prognostic factor the presence of a systemic pathology/drug assumption responsi...
Eligibility Criteria
Inclusion
- Use of a dry mouth product in the past 6 months
- Level of discomfort from dry mouth between 4 to 10 on a 0 (no discomfort) to 10 (extreme discomfort) scale
- Use of a dry mouth product at least 2-3 times per week
Exclusion
- History of any treatment for cancer in the last 3 months
- Recurrence of cancer and end stage of it
- Being on a restrictive dietary regimen
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05342272
Start Date
September 22 2017
End Date
October 30 2018
Last Update
April 22 2022
Active Locations (2)
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1
ASST Spedali Civili di Brescia
Brescia, BS, Italy, 25123
2
ASST Spedali Civili di Brescia
Brescia, Italy