Hypertension Clinical Trial
Official title:
Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Health, Ministry of Health | Nonthaburi |
Lead Sponsor | Collaborator |
---|---|
Dental Innovation Foundation Under Royal Patronage | Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University, Thammasat University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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