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Effect of Enzymatic-Containing Mouth Spray (Oral7®) on Xerostomia Symptoms, Salivary Flow Rate, and Oral Health-Related Quality of Life in Older Patients

RecruitingNAAges 60 Years - anyAllZAINAB MAT YUDIN
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In plain words

What the trial is, and whether it could suit you

Background: Xerostomia, or dry mouth, is a prevalent condition among older adults and has significant implications for oral and systemic health. It is associated with impaired chewing, swallowing, and speech, and increases the risk of oral infections, dental caries, and gum disease. Xerostomia may also contribute to malnutrition and aspiration pneumonia. Objective: This study aims to evaluate the effectiveness of an enzymatic-containing mouth spray (Oral7®) on xerostomia symptoms, unstimulated salivary flow rate, and oral health-related quality of life (OHRQoL) in older patients with xerostomia. Methods: A single-center, randomized, double-blind, placebo-controlled trial will be conducted at Hospital Universiti Sains Malaysia from August 2025 to July 2026. Eligible participants aged 60 and above with self-reported xerostomia will be randomly assigned to receive either Oral7® Mouth Spra

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 60 years and above * Patients with often or always having dry mouth/xerostomia by asking single-item xerostomia question: "How often does your mouth feel dry?" (Adakah mulut anda sering merasakan kekeringan?). The response options were "Never (Tidak Pernah)," "Sometimes (Kadang-kadang)," "Often (Kerap)," or "Always (Sentiasa/Sepanjang masa)." * Patients who are taking nutrition orally * Patients who are able to speak * Patients who are physically fit to take oral spray on their own. Exclusion Criteria: * • Patients on salivary substitutes for the past one week * Oral condition that required immediate attention such as mucosal or gingival bleeding, orofacial swelling, oral pain and oral ulcer. * Patients who are deaf and mute * Those with mental disabilities or documented cognitive deficits that would impair their ability to answer questions independently.
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What it tests

  • Oral7® mouth spray contains Natural Enzymes (Lactoperoxidase, Glucose Oxidase, Lactoferrin, Lysozyme), Calcium, Xylitol, Aloe Vera, Natural peppermint.
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Where

1 site
Universiti Sains Malaysia
Kubang Kerian, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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