Oral Health CareNCT07211906
Effects of Oral Nursing Education on Oral Health and Quality of Life in Patients With Home Non-Invasive Ventilator
A study testing oral hygiene education program in people with Oral Health Care and Oral Hygiene, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study evaluated the impact of oral care guidance on oral health and quality of life in patients using non-invasive ventilation at home. Using a randomized controlled trial, results showed significant improvements in oral hygiene, overall health, sleep quality, and daily living after the intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health Care, Oral Hygiene, Noninvasive Ventilators
- What is being tested?
- oral hygiene education program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 29 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Participants aged 18 years or older with full legal capacity. 2. Able to communicate in Mandarin or Taiwanese. 3. Currently using a non-invasive ventilator. 4. Individuals with natural dentition or complete edentulism will be included. 5. Able to operate and use the LINE communication application.
Who cannot join
- 1. Individuals who are unable to independently comprehend or respond to questions.
- 2. Individuals whose daily living activities rely on caregiver assistance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung University Of Science and Technology
Chiayi City, Taiwan
About this study
This study evaluated the impact of oral care guidance on oral health and quality of life in patients using non-invasive ventilation at home. Using a randomized controlled trial, results showed significant improvements in oral hygiene, overall health, sleep quality, and daily living after the intervention. Additionally, better oral care was positively associated with enhanced sleep quality and overall well-being. The findings suggest that targeted oral health education can effectively improve the health and quality of life for home non-invasive ventilation users, supporting its integration into clinical practice.
Read the detailed description
This study focused on exploring how providing specific oral care guidance can benefit individuals who rely on non-invasive ventilation (NIV) at home. Non-invasive ventilation is a respiratory support method used by people suffering from chronic respiratory conditions, such as COPD (chronic obstructive pulmonary disease), to help them breathe more easily without the need for invasive procedures like intubation.
The research aimed to see whether improving oral hygiene through targeted education could positively impact these patients' oral health, sleep quality, and overall quality of life. Since poor oral health has been linked to respiratory infections and other health complications, the study hypothesized that better oral care might help reduce related problems and enhance daily living.
In the study, participants receiving NIV at home were divided into two groups: one received comprehensive oral health guidance and education tailored to their needs, while the control group continued with usual care without additional instruction. The intervention included instructions on proper oral hygiene practices, such as effective brushing and oral cleaning, tailored to the specific needs of NIV users, and was provided over a period of three months.
Throughout the study, the researchers collected data on various aspects including oral health status, sleep quality, and overall life satisfaction. They used validated questionnaires like the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep and the Oral Health Impact Profile-14 (OHIP-14) to assess oral health-related quality of life.
The results demonstrated that patients who received the oral care guidance showed significant improvements in their oral health, sleep quality, and overall well-being compared to those in the control group. The intervention not only helped with maintaining better oral hygiene but also contributed to a better sleep experience and higher quality of life, reducing the negative impacts associated with respiratory diseases and the challenges of long-term NIV use.
Importantly, implementing such educational programs in clinical settings can empower patients to take better care of their oral health, which in turn may reduce the risk of infections and other complications, ultimately improving their daily lives. The study highlights the importance of integrating oral health education into the routine care for patients with chronic respiratory conditions on home NIV, emphasizing a holistic approach to patient health and quality of life.
- Being tested
- Control Group: oral hygiene education standard, oral hygiene education program
- Keywords
- Oral health, Oral hygiene, Noninvasive ventilation, Quality of Life, Sleep Quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group: oral hygiene education standardOther
oral hygiene education Standard care: oral hygiene education standard care, which involved providing participants with printed oral health education leaflets without additional personalized instruction or digital support. Specifically, participants were assessed at baseline, and then, at one-month intervals, they received printed oral care instructions and completed follow-up assessments. This group was not provided oral education or interactive guidance via digital platforms during the study period.
oral hygiene education programOther
Oral hygiene education program:
The oral hygiene education program includes a "Line-based oral care guidance program," which involves personalized, one-on-one oral health education facilitated through the Line communication platform. The process began with an initial pre-test assessment, including interviews and questionnaire evaluations. Then, the participants engaged in the "Line-guided oral care" intervention, where they received tailored guidance and demonstrated
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants receive routine oral care guidance or standard education materials without additional digital support or structured intervention. This group serves as a baseline to evaluate the effectiveness of the tailored oral health education and digital follow-up. Receives: Other: Control Group: oral hygiene education standard |
| Intervention | Experimental | The intervention group in this study received a structured oral care program integrated with technological support via Line communication. Specifically, participants in the experimental group were provided with personalized oral hygiene guidance through one-on-one oral care instruction, which included oral health education and demonstration. They also received continuous support and follow-up through the Line communication platform, where they could reply to educational prompts and clarify doubts, fostering adherence to oral care practices over a three-month period. This approach aimed to improve oral health outcomes and quality of life among home non-invasive ventilation users through a combination of direct guidance and digital communication. Receives: Other: Control Group: oral hygiene education standard; Other: oral hygiene education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Assessment Tool (OHAT)
his measure evaluates various aspects of oral health, such as lips, tongue, gingiva, saliva, natural teeth, dentures, oral cleanliness, and pain, with higher scores indicating poorer oral health. The study aims to determine if the oral health education intervention can significantly improve or maintain oral health status over the three-month period
Measured: The time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.
Secondary outcomes (1)
Pittsburgh Sleep Quality Index (PSQI)
This measure evaluates various aspects of sleep over the past month, including sleep quality, latency, duration, efficiency, disturbances, medication use, and daytime dysfunction. Higher PSQI scores indicate poorer sleep quality over the three-month period.
Measured: The time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Jul 2025
- Primary completion29 Mar 2026 (estimated)
- Study completion29 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health CareStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211906
- Sponsor's protocol ID
- 202500853B0
- Status last verified
- Jul 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nursing Education on Oral Health and Quality of Life in Patients With Home Non-Invasive Ventilator
- ClinicalTrials.gov ID
- NCT07211906
- Acronym / sponsor ID
- 202500853B0
- Keywords
- Oral health, Oral hygiene, Noninvasive ventilation, Quality of Life, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 29 Mar 2026 (estimated)
- Study completion
- 29 Mar 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the impact of oral care guidance on oral health and quality of life in patients using non-invasive ventilation at home. Using a randomized controlled trial, results showed significant improvements in oral hygiene, overall health, sleep quality, and daily living after the intervention. Additionally, better oral care was positively associated with enhanced sleep quality and overall well-being. The findings suggest that targeted oral health education can effectively improve the health and quality of life for home non-invasive ventilation users, supporting its integration into clinical practice.
Detailed description
This study focused on exploring how providing specific oral care guidance can benefit individuals who rely on non-invasive ventilation (NIV) at home. Non-invasive ventilation is a respiratory support method used by people suffering from chronic respiratory conditions, such as COPD (chronic obstructive pulmonary disease), to help them breathe more easily without the need for invasive procedures like intubation.
The research aimed to see whether improving oral hygiene through targeted education could positively impact these patients' oral health, sleep quality, and overall quality of life. Since poor oral health has been linked to respiratory infections and other health complications, the study hypothesized that better oral care might help reduce related problems and enhance daily living.
In the study, participants receiving NIV at home were divided into two groups: one received comprehensive oral health guidance and education tailored to their needs, while the control group continued with usual care without additional instruction. The intervention included instructions on proper oral hygiene practices, such as effective brushing and oral cleaning, tailored to the specific needs of NIV users, and was provided over a period of three months.
Throughout the study, the researchers collected data on various aspects including oral health status, sleep quality, and overall life satisfaction. They used validated questionnaires like the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep and the Oral Health Impact Profile-14 (OHIP-14) to assess oral health-related quality of life.
The results demonstrated that patients who received the oral care guidance showed significant improvements in their oral health, sleep quality, and overall well-being compared to those in the control group. The intervention not only helped with maintaining better oral hygiene but also contributed to a better sleep experience and higher quality of life, reducing the negative impacts associated with respiratory diseases and the challenges of long-term NIV use.
Importantly, implementing such educational programs in clinical settings can empower patients to take better care of their oral health, which in turn may reduce the risk of infections and other complications, ultimately improving their daily lives. The study highlights the importance of integrating oral health education into the routine care for patients with chronic respiratory conditions on home NIV, emphasizing a holistic approach to patient health and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control Group: oral hygiene education standardParticipants receive routine oral care guidance or standard education materials without additional digital support or structured intervention. This group serves as a baseline to evaluate the effectiveness of the tailored oral health education and digital follow-up. |
| Intervention | Experimental | Other: Control Group: oral hygiene education standard, Other: oral hygiene education programThe intervention group in this study received a structured oral care program integrated with technological support via Line communication. Specifically, participants in the experimental group were provided with personalized oral hygiene guidance through one-on-one oral care instruction, which included oral health education and demonstration. They also received continuous support and follow-up through the Line communication platform, where they could reply to educational prompts and clarify doubts, fostering adherence to oral care practices over a three-month period. This approach aimed to improve oral health outcomes and quality of life among home non-invasive ventilation users through a combination of direct guidance and digital communication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants aged 18 years or older with full legal capacity. 2. Able to communicate in Mandarin or Taiwanese. 3. Currently using a non-invasive ventilator. 4. Individuals with natural dentition or complete edentulism will be included. 5. Able to operate and use the LINE communication application.
Key exclusion criteria (2 listed)
- 1. Individuals who are unable to independently comprehend or respond to questions.
- 2. Individuals whose daily living activities rely on caregiver assistance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Group: oral hygiene education standardoral hygiene education Standard care: oral hygiene education standard care, which involved providing participants with printed oral health education leaflets without additional personalized instruction or digital support. Specifically, participants were assessed at baseline, and then, at one-month intervals, they received printed oral care instructions and completed follow-up assessments. This group was not provided oral education or interactive guidance via digital platforms during the study period. | Other | Control Group, Intervention |
| oral hygiene education programOral hygiene education program: The oral hygiene education program includes a "Line-based oral care guidance program," which involves personalized, one-on-one oral health education facilitated through the Line communication platform. The process began with an initial pre-test assessment, including interviews and questionnaire evaluations. Then, the participants engaged in the "Line-guided oral care" intervention, where they received tailored guidance and demonstrated | Other | Intervention |
Primary outcome
Oral Health Assessment Tool (OHAT)
Time frame: The time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.
his measure evaluates various aspects of oral health, such as lips, tongue, gingiva, saliva, natural teeth, dentures, oral cleanliness, and pain, with higher scores indicating poorer oral health. The study aims to determine if the oral health education intervention can significantly improve or maintain oral health status over the three-month period
1 secondary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: The time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral hygiene education program in people with Oral Health Care and Oral Hygiene, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Assessment Tool (OHAT) (time frame: The time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.