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Completed

NCT Number: NCT05640362

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.

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Key information

Conditions

Xerostomia Dry Mouth Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Oral7 mouthwash

Benzydamine mouthwash

Other

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

Other names: Difflam mouthwash

Primary outcomes

  1. Changes in symptoms

    Time frame: At Day 0 and Day 14 of intervention

    Symptoms of xerostomia assessment using Xerostomia Inventory

Secondary outcomes

  1. Changes in clinical signs

    Time frame: At Day 0 and Day 14 of intervention

    Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS)

  2. Salivary flow rate

    Time frame: At Day 0 and Day 14 of intervention

    Resting and stimulated salivary flow rate

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 7, 2022
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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