Actively Recruiting
Effect of Enzymatic-Containing Mouth Spray (Oral7 ae) on Xerostomia Symptoms, Salivary Flow Rate, and Oral Health-Related Quality of Life in Older Patients: A Randomised Placebo-Control Trial
Led by ZAINAB MAT YUDIN · Updated on 2026-05-22
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Xerostomia, commonly known as dry mouth, affects many older adults and can lead to difficulties with chewing, swallowing, speech, and increased risk of oral infections and dental problems. This trial evaluates an enzymatic mouth spray called Oral7 ae to see if it can reduce xerostomia symptoms, improve saliva flow, and enhance quality of life related to oral health in older patients. The study is a randomized, double-blind, placebo-controlled trial conducted at a single center. Participants aged 60 and above who experience dry mouth will be randomly assigned to use either the Oral7 ae mouth spray containing natural enzymes, calcium, xylitol, aloe vera, and peppermint, or a placebo spray made from distilled water. The intervention lasts for four weeks. The trial compares changes in xerostomia symptoms and saliva flow between the two groups, with follow-up assessments at baseline, after one month, and again three months post-intervention. During the study, participants will complete assessments including the Summated Xerostomia Inventory (SXI) to measure dry mouth symptoms, saliva flow rate tests, and the Geriatric Oral Health Assessment Index (GOHAI) to evaluate oral health-related quality of life. These measurements will be taken before treatment, after the four-week spray use, and three months later. Researchers will analyze the data to understand the mouth spray's impact on symptom relief, salivary function, and quality of life.
CONDITIONS
Brief Title
Effect of Enzymatic-Containing Mouth Spray (Oral7®) on Xerostomia Symptoms, Salivary Flow Rate, and Oral Health-Related Quality of Life in Older Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 60 years and above
- Often or always experiencing dry mouth as answered in a xerostomia question
- Taking nutrition orally
- Able to speak
- Physically fit to use an oral spray independently
You will not qualify if you...
- Using salivary substitutes in the past one week
- Having oral conditions needing immediate care such as bleeding, swelling, pain, or ulcers
- Deaf and mute
- Mental disabilities or cognitive problems affecting ability to answer questions independently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants use the Oral7® mouth spray or placebo spray to evaluate effects on dry mouth symptoms and oral health.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Actively Recruiting
Research Team
Z
ZAINAB MAT YUDIN, MEDICAL SCIENCES
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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