Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

ZAINAB MAT YUDIN

Conditions:

Xerostomia

Geriatric

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • • 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.

Key Trial Info

Start Date :

August 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06984848

Start Date

August 1 2025

End Date

December 1 2026

Last Update

May 29 2025

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