Salivary Gland DiseasesNCT04507646
The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population
A study testing True auricular acupuncture in people with Salivary Gland Diseases, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Salivary Gland Diseases
- What is being tested?
- True auricular acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2020to 30 Apr 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Salivary Gland Diseases
- Being tested
- True auricular acupuncture, sham auricular acupuncture
- Medical subject headings
- Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True auricular acupunctureOther
The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.
sham auricular acupunctureOther
The participant in control group will receive acupuncture on ineffective point at ear.
| Study group | Role | What they receive |
|---|---|---|
| True auricular acupuncture | Experimental | Effective auricular acupuncture Receives: Other: True auricular acupuncture |
| Sham auricular acupuncture | Sham comparator | Ineffective auricular acupuncture Receives: Other: sham auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective dry mouth health
self-rated salivation
Measured: pre-test and post-test
Objective dry mouth health
Salivation measured by Oral moisture meter
Measured: pre-test and post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start26 Aug 2020
- Primary completion2 Sep 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang, Hui-Chuan, Taipei Medical University
- Investigators
- Hui-Chuan Huang, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507646
- Sponsor's protocol ID
- N202001048
- Status last verified
- Apr 2022
- First submitted
- 26 Jul 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No