Study on Oral74 Mouth Spray for Relief of Dry Mouth and Improvement of Saliva Flow and Oral Health in Older Adults

What this Trial Is About

Xerostomia, commonly known as dry mouth, affects many older adults and can lead to difficulties with chewing, swallowing, speech, and increased risk of oral infections and dental problems. This trial evaluates an enzymatic mouth spray called Oral7ae to see if it can reduce xerostomia symptoms, improve saliva flow, and enhance quality of life related to oral health in older patients. The study is a randomized, double-blind, placebo-controlled trial conducted at a single center. Participants aged 60 and above who experience dry mouth will be randomly assigned to use either the Oral7ae mouth spray containing natural enzymes, calcium, xylitol, aloe vera, and peppermint, or a placebo spray made from distilled water. The intervention lasts for four weeks. The trial compares changes in xerostomia symptoms and saliva flow between the two groups, with follow-up assessments at baseline, after one month, and again three months post-intervention. During the study, participants will complete assessments including the Summated Xerostomia Inventory SXI to measure dry mouth symptoms, saliva flow rate tests, and the Geriatric Oral Health Assessment Index GOHAI to evaluate oral health-related quality of life. These measurements will be taken before treatment, after the four-week spray use, and three months later. Researchers will analyze the data to understand the mouth sprays impact on symptom relief, salivary function, and quality of life.

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