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

2026년 5월 6일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (실제)

78

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Postoperative Pain Intensity measured by Visual Analog Scale (VAS)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Preoperative Baseline Pain Level
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 9월 15일

기본 완료 (실제)

2026년 3월 15일

연구 완료 (실제)

2026년 3월 30일

연구 등록 날짜

최초 제출

2026년 5월 6일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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