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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nonthaburi, Thailand, 11000
        • Department of Health, Ministry of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in subjective dry mouth score
Time Frame: 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)
baseline, 2 weeks and 4 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in objective dry mouth score
Time Frame: 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)
baseline, 2 weeks and 4 weeks after intervention
Changes in salivary Potential of Hydrogen ion (pH)
Time Frame: 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)
baseline, 2 weeks and 4 weeks after intervention
Changes in salivary buffering capacity
Time Frame: 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)
baseline, 2 weeks and 4 weeks after intervention
Satisfaction of the edible gel-based artificial saliva
Time Frame: 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.
at the first day of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Estimate)

December 15, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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