NCT04507646

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

August 26, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

7 days

First QC Date

July 26, 2020

Last Update Submit

April 25, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Subjective dry mouth health

    self-rated salivation

    pre-test and post-test

  • Objective dry mouth health

    Salivation measured by Oral moisture meter

    pre-test and post-test

Study Arms (2)

True auricular acupuncture

EXPERIMENTAL

Effective auricular acupuncture

Other: True auricular acupuncture

Sham auricular acupuncture

SHAM COMPARATOR

Ineffective auricular acupuncture

Other: sham auricular acupuncture

Interventions

The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.

True auricular acupuncture

The participant in control group will receive acupuncture on ineffective point at ear.

Sham auricular acupuncture

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Residents in long-term institutions aged over 65 years old
  • Living in long-term institutions at least six months and above
  • Having normal cognitive functions with Mini-Mental State Examination scores more than 25 scores.

You may not qualify if:

  • The resident whose acupuncture point has Trauma, eczema or ulcer.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yilan Yuanshan Hopsital

Yilan, 26443, Taiwan

Location

MeSH Terms

Conditions

Salivary Gland Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Hui-Chuan Huang, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Two blinded researchers indenpendent performered auricular acupuncture for experimental or control group, respectively. Experimental group receive true auricular acupuncture and control group receive sham auricular acupuncture.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population

Study Record Dates

First Submitted

July 26, 2020

First Posted

August 11, 2020

Study Start

August 26, 2020

Primary Completion

September 2, 2020

Study Completion

April 30, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations