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Search / Trial NCT06984848

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

Launched by ZAINAB MAT YUDIN · May 14, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Xerostomia Dry Mouth Geriatric Older Patient

ClinConnect Summary

This clinical trial is studying the effects of a mouth spray called Oral7® on older adults who experience dry mouth, medically known as xerostomia. Dry mouth is a common issue among seniors that can make it hard to chew, swallow, and even speak, and it can lead to more serious problems like dental issues and infections. The goal of the study is to see if using this mouth spray can help reduce the symptoms of dry mouth, improve the amount of saliva produced, and enhance the overall quality of life related to oral health for those affected.

To participate in this trial, you need to be 60 years or older and often feel that your mouth is dry. Participants will be randomly assigned to receive either the Oral7® mouth spray or a placebo (a spray that does not contain the active ingredient) for four weeks. During the study, researchers will track changes in dry mouth symptoms and overall oral health. This trial is important because it could provide helpful information on how to better manage dry mouth in older adults, potentially leading to better oral health and well-being.

Gender

ALL

Eligibility criteria

  • 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.

About Zainab Mat Yudin

Zainab Mat Yudin is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative study designs and rigorous methodologies. With a strong focus on ethical standards and regulatory compliance, Zainab leads initiatives that facilitate the development of novel therapies across various therapeutic areas. Her expertise in trial management and collaboration with multidisciplinary teams ensures the efficient execution of clinical studies, fostering a culture of integrity and transparency in the pursuit of scientific excellence.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported