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

Dental Innovation Foundation Under Royal Patronage

Status: Completed

Conditions: Hypertension; Xerostomia; Diabetes Mellitus

Treatments: Other: Gel-based artificial saliva

Study type: Interventional

Funder types: Other

Identifiers

NCT02317172

DIF-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Gel-based artificial saliva

Experimental group

Description:

Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks

Treatment:

Other: Gel-based artificial saliva