Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

National University of Malaysia

Status: Completed

Conditions: Xerostomia; Dry Mouth

Treatments: Other: Benzydamine mouthwash; Other: Natural enzymes mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT05640362

UKM PPI/111/8/JEP-2016-582

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Benzydamine mouthwash

Placebo Comparator group

Treatment:

Other: Benzydamine mouthwash

Natural enzymes mouthwash

Experimental group

Treatment:

Other: Natural enzymes mouthwash