Oral7 Mouth Spray for dry mouth in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled study at Universiti Sains Malaysia to see if an enzymatic mouth spray called Oral7® helps with xerostomia in older adults. Participants aged 60+ with self-reported dry mouth will use Oral7® or placebo for four weeks. Primary outcome is the change in a xerostomia symptom score, with secondary measures including unstimulated salivary flow rate and oral-health-related quality of life. The study uses natural enzymes and other ingredients in the spray and compares outcomes between the active and placebo groups. Enrollment spans August 2025 to July 2026 and excludes individuals with recent salivary substitutes or conditions requiring urgent oral care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universiti Sains Malaysia
  Kubang Kerian, Kelantan, Malaysia Recruiting

Study contacts

• Study coordinator: Zainab Mat Yudin, Medical Sciences
• Email: drzainab@usm.my
• Phone: +601110622974

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.