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Effect of Sleep Apnea on Pain After Dental Treatment (OSA-EndoPain)

6 mai 2026 mis à jour par: Ahmet AKAY, Harran University

Relationship Between Obstructive Sleep Apnea and Postoperative Pain After Endodontic Treatment

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.

Aperçu de l'étude

Description détaillée

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.

Group 3 (n=30): Systemically healthy individuals without OSA (Control Group).

Exclusion criteria included the presence of periapical lesions on preoperative radiographs, chronic analgesic use, pregnancy, and failure to complete the study protocol. To minimize bias, the research team was blinded to the OSA classification process, and the data analyst was blinded during the statistical evaluation.

Standardized Endodontic Protocol To eliminate operator variability, all treatments were performed by a single experienced endodontist in a single session. Procedures were conducted under local anesthesia (2% lidocaine with 1:80,000 epinephrine) and rubber dam isolation. Root canal preparation was standardized using the VDW.ROTATE™ system up to a size 25.06 taper. The irrigation protocol included 5.25% NaOCl, 17% EDTA, and a final rinse with distilled water. Canals were obturated using the single-cone gutta-percha technique with AH Plus sealer.

Evaluation and Statistical Analysis Preoperative pain levels and postoperative pain at the 6th hour, 24th hour, and 7th day were recorded using a 10-point Visual Analog Scale (VAS) (0: no pain, 10: severe pain). The primary outcome was the difference in postoperative VAS scores between groups, while the secondary outcome was the duration of pain. Statistical analysis was performed using SPSS version 25. Due to non-normal distribution (confirmed via Kolmogorov-Smirnov test), the Kruskal-Wallis test with Bonferroni correction and the Mann-Whitney U test were utilized. The significance level was set at p < 0.05.

Type d'étude

Observationnel

Inscription (Réel)

78

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Outside of the US
      • Sanliurfa, Outside of the US, Turquie (Türkiye), 63300
        • Harran University Faculty of Dentristry,Departman of Endodonti

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
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 2 (Systemic Disease Only)
Patients diagnosed with systemic diseases such as Diabetes Mellitus and/or Hypertension, but who do not have Obstructive Sleep Apnea.
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 3 (Control Group)
Systemically healthy individuals without any diagnosed systemic diseases or Obstructive Sleep Apnea.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Postoperative Pain Intensity measured by Visual Analog Scale (VAS)
Délai: Preoperative (baseline), 6 hours, 24 hours, and 7 days after the endodontic treatment.
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Preoperative Baseline Pain Level
Délai: Baseline (Preoperative)
Assessment of the participants' pain intensity before the start of the endodontic treatment using the 10-point Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "severe pain". This measure is used to ensure baseline comparability between the groups.
Baseline (Preoperative)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 septembre 2025

Achèvement primaire (Réel)

15 mars 2026

Achèvement de l'étude (Réel)

30 mars 2026

Dates d'inscription aux études

Première soumission

6 mai 2026

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

12 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Individual participant data (IPD) that are completely de-identified will be shared. This includes demographic information (age and sex), Apnea-Hypopnea Index (AHI) values, systemic health status (diabetes and hypertension status), and preoperative and postoperative Visual Analog Scale (VAS) pain scores. No personally identifying information of the participants will be disclosed to protect patient privacy.

Délai de partage IPD

The data will be available starting 6 months after journal publication and will remain accessible for up to 3 years.

Critères d'accès au partage IPD

De-identified individual participant data can be requested by qualified researchers by emailing the corresponding author for academic and scientific purposes.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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