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

Not Applicable

Completed

• Conditions: Xerostomia; Hypertension; Diabetes Mellitus
• Interventions: Other: Gel-based artificial saliva

• Registration Number: NCT02317172
• Lead Sponsor: Dental Innovation Foundation Under Royal Patronage

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-12
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-11
• Last Update Submitted: 2014-12-11
• Study First Posted: 2014-12-15
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

Department of Health, Ministry of Health; 🇹🇭 Nonthaburi, Thailand