Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia; Dry Mouth
• Intervention / Treatment: Other: Benzydamine mouthwash; Other: Natural enzymes mouthwash

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50300
    • Faculty of Dentistry, Universiti Kebangsaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: Rifqah Nordin, MClinDent, National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2016
• Primary Completion (Actual): March 9, 2017
• Study Completion (Actual): March 24, 2017

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Estimate): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia; Anti-Inflammatory Agents; Benzydamine
• Other Study ID Numbers: UKM PPI/111/8/JEP-2016-582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No