- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07581964
Effect of Sleep Apnea on Pain After Dental Treatment (OSA-EndoPain)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Outside of the US
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Sanliurfa, Outside of the US, Turecko (Türkiye), 63300
- Harran University Faculty of Dentristry,Departman of Endodonti
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative Pain Intensity measured by Visual Analog Scale (VAS)
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Preoperative Baseline Pain Level
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Nemoci nervového systému
- Pooperační komplikace
- Patologické procesy
- Nemoci dýchacích cest
- Poruchy dýchání
- Poruchy spánku a bdění
- Apnoe
- Poruchy spánku, vnitřní
- Dysomnie
- Syndromy spánkové apnoe
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolest, pooperační
- Spánková apnoe, obstrukční
Další identifikační čísla studie
- HRU/25.15.53
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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