Diabetes Mellitus, Hypertension, Xerostomia
Conditions
Keywords
Saliva substitute, Edible gel, Xerostomia, Diabetes Mellitus, Hypertension
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.
Interventions
Gel-based artificial saliva is a novel gel-like, edible moisturizing gel designed to relieve dry mouth.
Sponsors
Thammasat University
Srinakharinwirot University
Mahidol University
Ministry of Health, Thailand
Dental Innovation Foundation Under Royal Patronage
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in subjective dry mouth score | baseline, 2 weeks and 4 weeks after intervention | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in objective dry mouth score | baseline, 2 weeks and 4 weeks after intervention | 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) |
| Changes in salivary Potential of Hydrogen ion (pH) | baseline, 2 weeks and 4 weeks after intervention | 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) |
| Changes in salivary buffering capacity | baseline, 2 weeks and 4 weeks after intervention | 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) |
| Satisfaction of the edible gel-based artificial saliva | at the first day of trial | 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. |
Countries
Thailand
Outcome results
None listed