Actively Recruiting
Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Molar Tooth Extraction Under Deep Sedation
Led by Gözde Nur Erkan · Updated on 2026-03-20
60
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
Sponsors
G
Gözde Nur Erkan
Lead Sponsor
T
TC Erciyes University
Collaborating Sponsor
AI-Summary
What this Trial Is About
In patients with high levels of fear and anxiety, it is recommended to perform dental procedures under sedation or general anesthesia depending on the nature of the procedure. In dental treatment under anesthesia, it is important that the procedure is comfortable and well tolerated by the patient. In addition, patient comfort is important in all dental procedures to prevent the development of avoidance behavior. During dental procedures performed under anesthesia, the oral cavity is completely within the scope of the surgical or procedure field. In this respect, sedation and general anesthesia in dental procedures and operations have specific risks and challenges.Since there is a risk of respiratory depression, hypoxia and hypercarbia during deep sedation, non-invasive ventilation support provided to patients with airway devices would be beneficial. In the research clinics where the study will be conducted, deep sedation with non-invasive mechanical ventilation support using a nasal CPAP (Continuous Positive Airway Pressure) mask or nasal airway is applied during the extraction of impacted molars. Thus, many dental procedures are routinely performed under deep sedation without the need for general anesthesia. There are very limited data in the literature on the use of a nasal CPAP mask during sedation for different procedures in patients with obstructive sleep apnea or obesity. However, no study comparing ventilation support during deep sedation with nasal CPAP mask and nasal airway has been found in the literature. The aim of this study is to compare the non-invasive ventilation support provided with 2 different airway devices during the procedure in terms of intraoperative and postoperative related complications, ventilation parameters, patient and surgeon satisfaction. The hypothesis of the study is that two different ventilation support methods during deep sedation may be superior to each other in terms of anesthesia quality, postoperative complications related to airway devices, patient and surgeon satisfaction. In the study, a total of 60 patients (Group airway, n;30, Group Mask, n;30) from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial \>0.8. The permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included.
CONDITIONS
Official Title
Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Molar Tooth Extraction Under Deep Sedation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer adult patients aged 18-60 years
- Patients scheduled for impacted tooth extraction
- Surgical procedure time between 20 and 60 minutes
- American Society of Anaesthesiologists (ASA) physical status I and II
- Body Mass Index (BMI) 30 or less
You will not qualify if you...
- Patients under 18 years old or over 60 years old
- Surgeries lasting less than 20 minutes or more than 1 hour
- American Society of Anaesthesiologists (ASA) physical status III or higher
- Conditions impairing decision-making ability such as mental retardation
- Respiratory diseases like asthma, chronic obstructive pulmonary disease, or airway hyperreactivity
- Severe narrowing of nasal passages (e.g., adenoid hypertrophy)
- Body Mass Index (BMI) greater than 30
- Patients who refuse to participate in the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Erciyes University Faculty of Dentistry
Kayseri, Turkey (Türkiye)
Actively Recruiting
2
Kırıkkale University Faculty of Dentistry
Kirikkale, Turkey (Türkiye)
Actively Recruiting
Research Team
G
Gözde Nur Erkan, Asst. Prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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