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

NCT02317172 | Completed

• 1 other identifier: DIF-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia; Hypertension; Diabetes Mellitus

Keywords

Saliva substitute; Edible gel; Xerostomia; Diabetes Mellitus; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Changes in objective dry mouth score

  baseline, 2 weeks and 4 weeks after intervention

• Changes in salivary Potential of Hydrogen ion (pH)

  baseline, 2 weeks and 4 weeks after intervention

• Changes in salivary buffering capacity

  baseline, 2 weeks and 4 weeks after intervention

• Satisfaction of the edible gel-based artificial saliva

  at the first day of trial

Study Arms (1)

Gel-based artificial saliva

EXPERIMENTAL

Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks

Other: Gel-based artificial saliva

Interventions

Gel-based artificial saliva OTHER

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

Also known as: Oral moisturizing jelly

Gel-based artificial saliva

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth
• Report symptoms of dry mouth

You may not qualify if:

• Subjects with uncontrolled systemic diseases
• Subjects who aspirate upon eating
• Subjects who smoke
• Subjects who are allergic to component of the intervention

Sponsors & Collaborators

• Dental Innovation Foundation Under Royal Patronage: lead
• Thammasat University: collaborator
• Srinakharinwirot University: collaborator
• Mahidol University: collaborator
• Ministry of Health, Thailand: collaborator

Study Sites (1)

Department of Health, Ministry of Health

Nonthaburi, 11000, Thailand

Location

Related Publications (1)

• Dalodom S, Lam-Ubol A, Jeanmaneechotechai S, Takamfoo L, Intachai W, Duangchada K, Hongsachum B, Kanjanatiwat P, Vacharotayangul P, Trachootham D. Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus. Geriatr Nurs. 2016 Mar-Apr;37(2):101-9. doi: 10.1016/j.gerinurse.2015.10.014. Epub 2015 Nov 26.

  PMID: 26631691 DERIVED

MeSH Terms

Conditions

Xerostomia; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Aroonwan Lam-ubol, DDS, PhD

  Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 15, 2014
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

TH (1)