MedDataX Logo

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

NCT ID: NCT02317172

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Xerostomia Hypertension Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Saliva substitute Edible gel Xerostomia Diabetes Mellitus Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gel-based artificial saliva

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

Group Type EXPERIMENTAL

Gel-based artificial saliva

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gel-based artificial saliva

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oral moisturizing jelly

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thammasat University

OTHER

Sponsor Role collaborator

Srinakharinwirot University

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

Dental Innovation Foundation Under Royal Patronage

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aroonwan Lam-ubol, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Srinakharinwirot University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Health, Ministry of Health

Nonthaburi, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26631691 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DIF-03

Identifier Type: -

Identifier Source: org_study_id