Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Conditions
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Xerostomia, Dry Mouth

Intervention / Treatment
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* Other: Natural enzymes mouthwash
* Other: Benzydamine mouthwash


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Benzydamine mouthwash<br> | Other: Benzydamine mouthwash<br>* Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.<br>* Other names: Difflam mouthwash;|
| Experimental: Natural enzymes mouthwash<br> | Other: Natural enzymes mouthwash<br>* 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.<br>* Other names: Oral7 mouthwash;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in symptoms | Symptoms of xerostomia assessment using Xerostomia Inventory | At Day 0 and Day 14 of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in clinical signs | Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS) | At Day 0 and Day 14 of intervention | 
| Salivary flow rate | Resting and stimulated salivary flow rate | At Day 0 and Day 14 of intervention |