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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04507646
Other study ID # N202001048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2020
Est. completion date April 30, 2021

Study information

Verified date April 2022
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to examine the effect of auricular acupuncture on improving oral health in older population. The hypothesis of this study is that older people receiving auricular acupuncture can increase salivary secretion. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.


Description:

The elderly living in long-term institutions are mostly limited to physical dysfunction and highly dependence. In addition, the chronic diseases are affected by taking a variety of drugs, which may easily lead to dry mouth. Thus, providing oral health to increase secretion of saliva is high recommended to those older population. The study is used to examine the effect of auricular acupuncture on improving oral health in older population. The eligible participants are random assign to experimental group receiving auricular acupuncture and control group having ineffective auricular acupuncture. Outcome measures include demographic variables, general health status and secretion of saliva, such as: Subjective dry mouth condition and objective mouth condition. Generalized linear model will be used to examine the effect of auricular acupuncture on improving oral health. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date April 30, 2021
Est. primary completion date September 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Residents in long-term institutions aged over 65 years old 2. Living in long-term institutions at least six months and above 3. Having normal cognitive functions with Mini-Mental State Examination scores more than 25 scores. Exclusion Criteria: 1. The resident whose acupuncture point has Trauma, eczema or ulcer. 2. Incapable of salivary secretion caused by disease,sush as radiation-induced xerostomia among patients with nasopharyngeal carcinoma, Sjogren's Syndrome,acute sialadenitis,chronic recurrent sialadenitis,viral salivary gland infection,salivary gland stones.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
True auricular acupuncture
The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.
sham auricular acupuncture
The participant in control group will receive acupuncture on ineffective point at ear.

Locations

Country Name City State
Taiwan Yilan Yuanshan Hopsital Yilan City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective dry mouth health self-rated salivation pre-test and post-test
Primary Objective dry mouth health Salivation measured by Oral moisture meter pre-test and post-test
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