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Completed

NCT Number: NCT02317172

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.

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Key information

Conditions

Xerostomia Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Salivary Gland Diseases Stomatognathic Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health, Ministry of Health

Nonthaburi, 11000, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gel-based artificial saliva

Other

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

Other names: Oral moisturizing jelly

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dental Innovation Foundation Under Royal Patronage

Other

Collaborators

  • Mahidol University
  • Ministry of Health, Thailand
  • Srinakharinwirot University
  • Thammasat University

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2014
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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