Effect of Sleep Apnea on Pain After Dental Treatment

NCT07581964 | Completed

• 1 other identifier: HRU/25.15.53
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension Complicated With Type 2 Diabetes; Obstructive Sleep Apnea; Postoperative Pain

Keywords

Obstructive Sleep Apnea; Root Canal Therapy; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity measured by Visual Analog Scale (VAS)

  Pain intensity is self-reported by patients using a 10-point Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "severe pain".

  Preoperative (baseline), 6 hours, 24 hours, and 7 days after the endodontic treatment.

Secondary Outcomes (1)

• Preoperative Baseline Pain Level

  Baseline (Preoperative)

Study Arms (3)

Grup 1 (OSA + Systemic Disease)

Patients diagnosed with moderate (AHI 15-30) or severe (AHI \>30) Obstructive Sleep Apnea (OSA) via polysomnography, who also have systemic diseases such as Diabetes Mellitus and/or Hypertension.

Procedure: Standard Endodontic Treatment

Grup 2 (Systemic Disease Only)

Patients diagnosed with systemic diseases such as Diabetes Mellitus and/or Hypertension, but who do not have Obstructive Sleep Apnea.

Procedure: Standard Endodontic Treatment

Grup 3 (Control Group)

Systemically healthy individuals without any diagnosed systemic diseases or Obstructive Sleep Apnea.

Procedure: Standard Endodontic Treatment

Interventions

Standard Endodontic Treatment PROCEDURE

Standardized single-session root canal treatment performed under rubber dam isolation and local anesthesia. Root canals are prepared using the VDW.ROTATE™ rotary system, irrigated with 5.25% NaOCl and 17% EDTA, and obturated with the single-cone technique using AH Plus sealer.

Grup 1 (OSA + Systemic Disease); Grup 2 (Systemic Disease Only); Grup 3 (Control Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients seeking endodontic treatment at the Harran University Faculty of Dentistry, Department of Endodontics. Participants are selected consecutively from individuals who have undergone polysomnography in an accredited sleep laboratory (for the OSA groups) and from patients with diagnosed systemic conditions such as diabetes and hypertension.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University Faculty of Dentristry,Departman of Endodonti

Sanliurfa, Outside of the US, 63300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pain, Postoperative

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: September 15, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available starting 6 months after journal publication and will remain accessible for up to 3 years.
• Access Criteria: De-identified individual participant data can be requested by qualified researchers by emailing the corresponding author for academic and scientific purposes.

Locations

TU (1)