Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases

Study Overview
=================
Brief Summary
-----------------
Elderly people usually have systemic diseases and take medications that can cause dry mouth. The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.

Detailed Description
-----------------
A pre-post test trial was conducted in 120 elders with xerostomia. All subjects received a total of 50 ml (10ml x 5 times) OMJ per day. Subjective and objective dry mouth scores, salivary pH, buffering capacity and satisfaction were monitored at 2 weeks and 1 month use, compared to baseline. The data were analyzed by Repeated Measure ANOVA.

Official Title
-----------------
Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases

Conditions
-----------------
Hypertension, Diabetes Mellitus, Xerostomia

Intervention / Treatment
-----------------
* Other: Gel-based artificial saliva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth Report symptoms of dry mouth Exclusion Criteria: Subjects with uncontrolled systemic diseases Subjects who aspirate upon eating Subjects who smoke Subjects who are allergic to component of the intervention

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gel-based artificial saliva<br>Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks | Other: Gel-based artificial saliva<br>* Gel-based artificial saliva is a novel gel-like, edible moisturizing gel designed to relieve dry mouth.<br>* Other names: Oral moisturizing jelly;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in subjective dry mouth score | The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) | baseline, 2 weeks and 4 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in objective dry mouth score | The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) | baseline, 2 weeks and 4 weeks after intervention | 
| Changes in salivary Potential of Hydrogen ion (pH) | The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) | baseline, 2 weeks and 4 weeks after intervention | 
| Changes in salivary buffering capacity | The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week) | baseline, 2 weeks and 4 weeks after intervention | 
| Satisfaction of the edible gel-based artificial saliva | All subjects will try a few spoon of the edible gel based saliva and a commercially available inedible gel-based saliva. Then, all subjects will be interviewed for satisfaction of both products and compare the results. | at the first day of trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saliva substitute, Edible gel, Xerostomia, Diabetes Mellitus, Hypertension