Comparing nasal CPAP masks and nasal airways for tooth extraction under sedation
Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Terms of Intraoperative Anesthesia Quality and Postoperative Associated Complications in Impacted Molar Tooth Extraction Patients Under Deep Sedation; A Multi-Center Study
This study is testing whether nasal CPAP masks or nasal airways provide better breathing support and comfort for adults during tooth extractions done under sedation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Kırıkkale University Academic / other |
| Locations | 2 sites (Kayseri and 1 other locations) |
| Trial ID | NCT06436638 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of nasal continuous positive airway pressure (CPAP) masks versus nasal airways in providing non-invasive ventilation support during impacted molar tooth extractions performed under deep sedation. A total of 60 adult patients will be included, with half receiving nasal CPAP masks and the other half receiving nasal airways. The study will monitor various parameters such as blood pressure, heart rate, oxygen saturation, and ventilation metrics to assess patient comfort and safety during the procedure. The aim is to determine which method offers better respiratory support and overall patient experience during dental surgeries.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18-60 scheduled for impacted molar extractions with a procedure time between 20 to 60 minutes.
Not a fit: Patients with respiratory diseases, severe nasal passage obstructions, or those outside the specified age and BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient comfort and safety during dental procedures requiring sedation.
How similar studies have performed: While the approach of using non-invasive ventilation during dental procedures is established, this specific comparison of nasal CPAP masks and nasal airways is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Volunteer adult patients aged 18-60 years * Patients scheduled for impacted tooth extraction * Cases with surgical time ≥20 minutes and ≤60 minutes * American Society of Anaesthesiologists (ASA) physical status I and II patients * Patients with BMI≤30 Exclusion Criteria: * Patients under 18 years old-over 60 years old * Surgeries with a procedure time over 1 hour or less than 20 minutes * American Society of Anaesthesiologists (ASA) physical status III and higher patients * Presence of conditions such as mental retardation that impair the patient's ability to make decisions about himself/herself * Patients with respiratory system diseases such as asthma, chronic obstructive pulmonary disease (COPD) or airway hyperreactivity * Patients with a condition that severely narrows the nasal passage opening (e.g. adenoid hypertrophy, etc.) * Patients with BMI\>30 * Patients who refused to participate in the study
Where this trial is running
Kayseri and 1 other locations
- Erciyes University Faculty of Dentistry — Kayseri, Turkey (Türkiye) (Recruiting)
- Kırıkkale University Faculty of Dentistry — Kirikkale, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Gözde Nur Erkan, Asst. Prof.
- Email: dr.gozdenur@gmail.com
- Phone: +905054334692
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.