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Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Sponsor
National University of Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT05640362
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
4.4
Actual Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Natural enzymes mouthwash
  • Other: Benzydamine mouthwash
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
Actual Study Start Date :
Nov 10, 2016
Actual Primary Completion Date :
Mar 9, 2017
Actual Study Completion Date :
Mar 24, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in symptoms [At Day 0 and Day 14 of intervention]

      Symptoms of xerostomia assessment using Xerostomia Inventory

    Secondary Outcome Measures

    1. Changes in clinical signs [At Day 0 and Day 14 of intervention]

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

    2. Salivary flow rate [At Day 0 and Day 14 of intervention]

      Resting and stimulated salivary flow rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Universiti Kebangsaan Malaysia Kuala Lumpur Malaysia 50300

    Sponsors and Collaborators

    • National University of Malaysia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National University of Malaysia
    ClinicalTrials.gov Identifier:
    NCT05640362
    Other Study ID Numbers:
    • UKM PPI/111/8/JEP-2016-582
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Dec 7, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Xerostomia
    Benzydamine

    Study Results

    No Results Posted as of Dec 7, 2022