Relationship Between Obstructive Sleep Apnea and Postoperative Pain After Endodontic Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harran University
- Enrollment
- 78
- Locations
- 1
Study Overview
Brief Summary
This observational study aims to investigate the effects of sleep quality and systemic health status on pain levels following endodontic treatment in adult patients. The primary goal is to determine how obstructive sleep apnea and common systemic conditions (diabetes and hypertension) influence postoperative dental pain.
The key questions it aims to answer are:
Does the severity of Obstructive Sleep Apnea (OSA) lead to higher postoperative pain scores after root canal treatment?
How does the presence of systemic diseases, such as diabetes and hypertension, affect pain perception compared to healthy individuals and OSA patients?
Comparison Groups:
Researchers will compare outcomes across three distinct cohorts:
OSA Group: Patients diagnosed with moderate-to-severe obstructive sleep apnea via polysomnography.
Systemic Disease Group: Patients with diagnosed systemic conditions, specifically diabetes and hypertension.
Control Group: Systemically healthy individuals without sleep disorders.
Participants will:
Undergo a polysomnography (PSG) evaluation to assess their sleep status.
Receive routine, standard-of-care endodontic treatment.
Record and report their pain intensity using the Visual Analog Scale (VAS) at specific intervals after the procedure.
Detailed Description
Study Design and Power Analysis This observational study was designed to evaluate the interaction between Obstructive Sleep Apnea (OSA) and systemic diseases on postoperative pain following endodontic treatment. A power analysis was performed using G*Power 3.1 software with parameters f=0.40, α=0.05, and 80% power. While the analysis indicated a minimum of 66 participants, a total of 75 participants were targeted to account for a potential 15% dropout rate. The study was completed with 78 participants, maintaining and enhancing the required statistical power.
Participant Selection and Grouping
Patients aged 28 to 63 were enrolled based on their clinical status and divided into three groups:
Group 1 (n=24): Patients diagnosed with moderate (AHI 15-30) or severe (AHI >30) OSA via polysomnography (PSG) in an accredited sleep laboratory, who also presented with systemic diseases (Diabetes Mellitus and/or Hypertension).
Group 2 (n=24): Patients with diagnosed systemic diseases (Diabetes Mellitus and/or Hypertension) but without OSA.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged between 18 and 65 years.
- •Clinical requirement for endodontic (root canal) treatment.
- •Presence of a restorable tooth structure.
- •Diagnosis of moderate (AHI 15-30) or severe (AHI > 30) obstructive sleep apnea (OSA) confirmed by polysomnography, for relevant groups.
- •Patients with diagnosed systemic diseases (Diabetes Mellitus and/or Hypertension) or systemically healthy controls according to group allocation.
Exclusion Criteria
- •Presence of periapical lesions identified during preoperative radiographic evaluation.
- •Chronic use of analgesics or long-term pain-management medications.
- •Pregnancy.
- •Failure to complete the established study protocol.
Investigators
Ahmet AKAY
Assistant Professor
Harran University