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

Primary Purpose

Xerostomia, Hypertension, Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Gel-based artificial saliva

About this trial

This is an interventional supportive care trial for Xerostomia focused on measuring Saliva substitute, Edible gel, Xerostomia, Diabetes Mellitus, Hypertension

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Health, Ministry of Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gel-based artificial saliva

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in objective dry mouth score

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)

Changes in salivary Potential of Hydrogen ion (pH)

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)

Changes in salivary buffering capacity

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)

Satisfaction of the edible gel-based artificial saliva

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.

Full Information

NCT ID

NCT02317172

First Posted

December 11, 2014

Last Updated

December 11, 2014

Sponsor

Dental Innovation Foundation Under Royal Patronage

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02317172

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dental Innovation Foundation Under Royal Patronage

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerostomia, Hypertension, Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gel-based artificial saliva

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Gel-based artificial saliva

Other Intervention Name(s)

Oral moisturizing jelly

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in subjective dry mouth score

Description

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)

Time Frame

baseline, 2 weeks and 4 weeks after intervention

Secondary Outcome Measure Information:

Title

Changes in objective dry mouth score

Description

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)

Time Frame

baseline, 2 weeks and 4 weeks after intervention

Title

Changes in salivary Potential of Hydrogen ion (pH)

Description

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)

Time Frame

baseline, 2 weeks and 4 weeks after intervention

Title

Changes in salivary buffering capacity

Description

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)

Time Frame

baseline, 2 weeks and 4 weeks after intervention

Title

Satisfaction of the edible gel-based artificial saliva

Description

Time Frame

at the first day of trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aroonwan Lam-ubol, DDS, PhD

Organizational Affiliation

Srinakharinwirot University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Health, Ministry of Health

City

Nonthaburi

ZIP/Postal Code

11000

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

26631691

Citation

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.

Results Reference

derived

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

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