Dry Mouth, Xerostomia
Conditions
Brief summary
The goal of this clinical is to assess the efficacy of natural enzymes mouthwash in the treatment of xerostomia (dry mouth). The main questions it aims to answer are: (1) the efficacy of natural enzymes mouthwash in the symptomatic treatment of xerostomia; and (2) the response of xerostomia patients towards natural enzymes mouthwash. Participants were given a mouthwash to be used. Intervention group received natural enzymes moisturising mouthwash, while control group received benzydamine mouthwash. Mouthwashes were repacked, labelled with specific code and were given to participants by third-party. Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. Data were compared within each arm before and after using the mouthwashes; and between both arms after using the mouthwashes.
Interventions
OTHERNatural enzymes mouthwash
Natural enzymes mouthwash contains numerous natural protein-enzymes, including lactoferrin, lysozyme, lactoperoxidase, glucose oxidase. These active ingredients were proposed to render this mouthwash to act as salivary substitutes by reinforcing the functions of available saliva, hence reinforcing the immune system in the oral cavity. It was expected to relieve the symptoms in xerostomia patients, and even more if the patients have salivary flow reduction by improving the functions of the limited amount of saliva. The potential mechanisms of action of the mouthwash to treat xerostomia may be related to: (1) lubrication effects to wet the oral mucosal surfaces; (2) antimicrobial properties that will reduce risks of mucosal irritation by infections; (3) absence of alcohol in the mouthwash Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.
OTHERBenzydamine mouthwash
Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years old and above, * complained of dry mouth (xerostomia), and * taking nutrition orally
Exclusion criteria
* patients who had been using mouthwash for xerostomia in the past 1 week, * unable to provide saliva samples, * unable to chew paraffin wax for stimulated saliva, * patients with oral motor function deficits, and * those with severe cognitive deterioration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in symptoms | At Day 0 and Day 14 of intervention | Symptoms of xerostomia assessment using Xerostomia Inventory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in clinical signs | At Day 0 and Day 14 of intervention | Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS) |
| Salivary flow rate | At Day 0 and Day 14 of intervention | Resting and stimulated salivary flow rate |
Countries
Malaysia
Outcome results
None listed