- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02317172
Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
December 11, 2014 updated by: Dental Innovation Foundation Under Royal Patronage
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
Conditions
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
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-
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Nonthaburi, Thailand, 11000
- Department of Health, Ministry of Health
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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:
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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
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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)
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baseline, 2 weeks and 4 weeks after intervention
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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
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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.
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at the first day of trial
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIF-03
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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