NCT05640362

Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Xerostomia
• Dry Mouth

Interventions

Type	Name	Description
OTHER	Natural 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.
OTHER	Benzydamine mouthwash	Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.

Timeline

• Start date: 2016-11-10
• Primary completion: 2017-03-09
• Completion: 2017-03-24
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

1 site across 1 country: Malaysia