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

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ClinicalTrials.gov Identifier: NCT02317172
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : December 15, 2014
Sponsor:
Collaborators:
Thammasat University
Srinakharinwirot University
Mahidol University
Ministry of Health, Thailand
Information provided by (Responsible Party):
Dental Innovation Foundation Under Royal Patronage

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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 : October 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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 Name: Oral moisturizing jelly




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317172


Locations
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Thailand
Department of Health, Ministry of Health
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Dental Innovation Foundation Under Royal Patronage
Thammasat University
Srinakharinwirot University
Mahidol University
Ministry of Health, Thailand
Investigators
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Principal Investigator: Aroonwan Lam-ubol, DDS, PhD Srinakharinwirot University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dental Innovation Foundation Under Royal Patronage
ClinicalTrials.gov Identifier: NCT02317172     History of Changes
Other Study ID Numbers: DIF-03
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by Dental Innovation Foundation Under Royal Patronage:
Saliva substitute
Edible gel
Xerostomia
Diabetes Mellitus
Hypertension

Additional relevant MeSH terms:
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Xerostomia
Mouth Diseases
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Salivary Gland Diseases
Stomatognathic Diseases