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Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Primary Purpose

Xerostomia, Dry Mouth

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Natural enzymes mouthwash
Benzydamine mouthwash
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Xerostomia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Universiti Kebangsaan Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Benzydamine mouthwash

Natural enzymes mouthwash

Arm Description

Outcomes

Primary Outcome Measures

Changes in symptoms
Symptoms of xerostomia assessment using Xerostomia Inventory

Secondary Outcome Measures

Changes in clinical signs
Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS)
Salivary flow rate
Resting and stimulated salivary flow rate

Full Information

First Posted
November 28, 2022
Last Updated
November 28, 2022
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05640362
Brief Title
Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
Official Title
Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Dry Mouth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benzydamine mouthwash
Arm Type
Placebo Comparator
Arm Title
Natural enzymes mouthwash
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Natural enzymes mouthwash
Other Intervention Name(s)
Oral7 mouthwash
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Benzydamine mouthwash
Other Intervention Name(s)
Difflam mouthwash
Intervention Description
Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.
Primary Outcome Measure Information:
Title
Changes in symptoms
Description
Symptoms of xerostomia assessment using Xerostomia Inventory
Time Frame
At Day 0 and Day 14 of intervention
Secondary Outcome Measure Information:
Title
Changes in clinical signs
Description
Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS)
Time Frame
At Day 0 and Day 14 of intervention
Title
Salivary flow rate
Description
Resting and stimulated salivary flow rate
Time Frame
At Day 0 and Day 14 of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rifqah Nordin, MClinDent
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Universiti Kebangsaan Malaysia
City
Kuala Lumpur
ZIP/Postal Code
50300
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

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