Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

NCT05640362 | Completed

• 1 other identifier: UKM PPI/111/8/JEP-2016-582
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia; Dry Mouth

Outcome Measures

Primary Outcomes (1)

• Changes in symptoms

  Symptoms of xerostomia assessment using Xerostomia Inventory

  At Day 0 and Day 14 of intervention

Secondary Outcomes (2)

• Changes in clinical signs

  At Day 0 and Day 14 of intervention

• Salivary flow rate

  At Day 0 and Day 14 of intervention

Study Arms (2)

Benzydamine mouthwash

PLACEBO COMPARATOR

Other: Benzydamine mouthwash

Natural enzymes mouthwash

EXPERIMENTAL

Other: Natural enzymes mouthwash

Interventions

Natural enzymes mouthwash OTHER

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.

Also known as: Oral7 mouthwash

Natural enzymes mouthwash

Benzydamine mouthwash OTHER

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

Also known as: Difflam mouthwash

Benzydamine mouthwash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and above,
• complained of dry mouth (xerostomia), and
• taking nutrition orally

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Faculty of Dentistry, Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (1)

• Chiam TL, Choo J, Ashar A, Hussaini HM, Rajandram RK, Nordin R. Efficacy of natural enzymes mouthwash: a randomised controlled trial. Clin Oral Investig. 2024 Apr 19;28(5):259. doi: 10.1007/s00784-024-05658-7.

  PMID: 38639763 DERIVED

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Rifqah Nordin, MClinDent

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: November 10, 2016
• Primary Completion: March 9, 2017
• Study Completion: March 24, 2017
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)