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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317172
• Other study ID #: DIF-03
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: December 11, 2014
• Start date: October 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: Dental Innovation Foundation Under Royal Patronage
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Health, Ministry of Health	Nonthaburi

Sponsors (5)

Lead Sponsor	Collaborator
Dental Innovation Foundation Under Royal Patronage	Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University, Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

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