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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02317172
Other study ID # DIF-03
Secondary ID
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


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
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