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

Sponsor

Dental Innovation Foundation Under Royal Patronage (Other)

Overall Status

Completed

CT.gov ID

NCT02317172

Collaborator

Thammasat University (Other), Srinakharinwirot University (Other), Mahidol University (Other), Ministry of Health, Thailand (Other)

120

Enrollment

Location

Arm

Duration (Months)

24.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Hypertension Diabetes Mellitus	Other: Gel-based artificial saliva	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Gel-based artificial saliva

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

Other: Gel-based artificial saliva

Gel-based artificial saliva is a novel gel-like, edible moisturizing gel designed to relieve dry mouth.

Other Names:

Oral moisturizing jelly

Outcome Measures

Primary Outcome Measures

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

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.