How inhaler use affects oral health in people with COPD
Effect of Inhaler Medication Use on Oral Health in COPD Patients: A Randomized Controlled Trial
NA · Çankırı Karatekin University · NCT07000604
This trial will test whether a short mouth-care training helps people with COPD who use inhalers keep their mouths healthier.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Çankırı Karatekin University (other) |
| Locations | 1 site (Çankırı) |
| Trial ID | NCT07000604 on ClinicalTrials.gov |
What this trial studies
Adults with COPD who use metered dose inhalers are randomized to receive a single brief mouth-care education session or no education, with data collected by face-to-face questionnaires. Informed consent is obtained and questionnaires take about 20–25 minutes to complete, with researchers checking for missing answers during the visit. The intervention group receives the mouth care training and the control group receives no training. Oral health is re-evaluated about three months after the baseline visit at the study site.
Who should consider this trial
Good fit: Adults (18+) diagnosed with COPD for at least six months who use a metered dose inhaler, are communicative, and have no current COPD exacerbation or respiratory infection are eligible.
Not a fit: Patients not using MDIs, those with active respiratory infections or recent exacerbations, or people unwilling or unable to complete the baseline and 3‑month follow-up visits are unlikely to benefit.
Why it matters
Potential benefit: If successful, the training could reduce inhaler-related oral problems such as thrush or dry mouth and improve everyday oral hygiene for participants.
How similar studies have performed: Previous small trials and clinical reports have suggested oral hygiene education can reduce inhaler-related mouth side effects, so the approach has some supportive but limited evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with COPD for at least 6 months, * Outpatient and inpatient, * Consent to participate in the research, * Not under the age of eighteen, * With a metered dose inhaler (MDI) in treatment, * No communication barriers, * No COPD exacerbation and/or respiratory tract infection, * According to the GOLD report; mild (Stage 1), moderate (Stage 2), severe (Stage 3). Exclusion Criteria: * Diagnosed with COPD for less than 6 months, * Refused to participate in the research, * Treatment without metered dose inhalers (MDIs), * Uncommunicative, * Those who withdrew from participating in the study during data collection, * Not completing the survey, * COPD exacerbation and/or respiratory tract infection,
Where this trial is running
Çankırı
- Çankiri Devlet Hastanesi — Çankırı, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Betül Yalçın, 2 — Çankırı Karatekin University
- Study coordinator: BETÜL YALÇIN, 2
- Email: betulozylmz@gmail.com
- Phone: +905536048980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease