Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Dry Mouth; Xerostomia
• Interventions: Other: Benzydamine mouthwash; Other: Natural enzymes mouthwash

• Registration Number: NCT05640362
• Lead Sponsor: National University of Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-10
• Primary Completion: 2017-03-09
• Study Completion: 2017-03-24
• Status Verified: 2022-11
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Benzydamine mouthwash	Benzydamine mouthwash	-
Natural enzymes mouthwash	Natural enzymes mouthwash	-

Primary Outcome Measures

Name	Time	Method
Changes in symptoms	At Day 0 and Day 14 of intervention	Symptoms of xerostomia assessment using Xerostomia Inventory

Secondary Outcome Measures

Name	Time	Method
Salivary flow rate	At Day 0 and Day 14 of intervention	Resting and stimulated salivary flow rate
Changes in clinical signs	At Day 0 and Day 14 of intervention	Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS)

Trial Locations

Locations (1)

Faculty of Dentistry, Universiti Kebangsaan Malaysia; 🇲🇾 Kuala Lumpur, Malaysia