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

NCT ID: NCT06984848

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-01

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 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 Spray or a placebo spray for four weeks. The primary outcome is the mean change in Summated Xerostomia Inventory (SXI) scores between groups from baseline to post-intervention. Secondary outcomes include changes in unstimulated salivary flow rate using the sialometry technique and OHRQoL measured by the Geriatric Oral Health Assessment Index (GOHAI) at baseline and three months post-intervention. Data will be analyzed using SPSS version 29.

Conclusion: This trial will provide evidence on the efficacy of Oral7® Mouth Spray in alleviating xerostomia symptoms and improving salivary function and oral health-related quality of life in older adults, potentially guiding future clinical management of this condition.

Conditions

Xerostomia; Geriatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group: Oral7® mouth spray

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

Group Type: EXPERIMENTAL

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

Intervention Type: COMBINATION_PRODUCT

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

Control group

The formulation of the placebo mouth spray is derived from distilled water which will be packaging into an identical spray bottle.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Oral7®

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZAINAB MAT YUDIN

INDUSTRY

Sponsor Role: lead

Responsible Party

ZAINAB MAT YUDIN

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

MBDMARKETING

Identifier Type: -

Identifier Source: org_study_id