Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Xerostomia Clinical Trial

Official title:

Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640362
• Other study ID #: UKM PPI/111/8/JEP-2016-582
• Status: Completed
• Phase: N/A
• Start date: November 10, 2016
• Est. completion date: March 24, 2017

Study information

• Verified date: November 2022
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 24, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Mouth
• Xerostomia

Intervention

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.
• Benzydamine mouthwash
Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.

Locations

Country	Name	City	State
Malaysia	Faculty of Dentistry, Universiti Kebangsaan Malaysia	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in symptoms	Symptoms of xerostomia assessment using Xerostomia Inventory	At Day 0 and Day 14 of intervention
Secondary	Changes in clinical signs	Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS)	At Day 0 and Day 14 of intervention
Secondary	Salivary flow rate	Resting and stimulated salivary flow rate	At Day 0 and Day 14 of intervention