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Postoperative Pain After OCT or EDTA Irrigation in Regenerative Endodontic Treatment

20. července 2026 aktualizováno: Busranur Yavuz, TC Erciyes University

Effect of Different Irrigation Protocols on Postoperative Pain Following Regenerative Endodontic Treatment: A Randomized Clinical Trial

This randomized clinical trial evaluated the effect of two different irrigation solutions on postoperative pain following regenerative endodontic treatment of necrotic immature permanent teeth with apical periodontitis. Participants were randomly allocated to receive either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) during regenerative endodontic treatment.

A total of 40 patients aged 9 to 16 years were included and allocated to the two intervention groups in a 1:1 ratio. Postoperative pain was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from the second through the seventh postoperative day. Analgesic use and the occurrence of flare-up were also evaluated.

Přehled studie

Detailní popis

Necrotic immature permanent teeth with apical periodontitis present a clinical challenge because incomplete root development is associated with thin dentinal walls, an open apex, and an increased risk of root fracture. Regenerative endodontic treatment is a biologically based procedure that aims to control intracanal infection, promote healing of the periapical tissues, and allow continued root development.

Successful regenerative endodontic treatment requires effective root canal disinfection while preserving an environment that supports the survival and activity of stem cells from the apical papilla. Ethylenediaminetetraacetic acid (EDTA) is commonly used in regenerative procedures because of its chelating properties, its ability to modify the dentin surface, and its potential to promote the release of dentin-derived bioactive molecules. Octenidine dihydrochloride (OCT) is a broad-spectrum antiseptic that has demonstrated antimicrobial activity and potentially favorable biological effects on dental-derived stem cells. However, clinical evidence regarding the use of OCT during regenerative endodontic treatment remains limited.

This prospective, participant-blinded, parallel-group randomized clinical trial included 40 systemically healthy patients aged 9 to 16 years who had a necrotic immature permanent tooth with apical periodontitis. Eligible teeth had Cvek stage 2 or 3 root development and a baseline Periapical Index score between 2 and 4. Each participant contributed one tooth to the study.

Participants were randomly assigned in a 1:1 ratio to one of two irrigation groups:

  1. The OCT group received 0.1% octenidine dihydrochloride.
  2. The EDTA group received 17% ethylenediaminetetraacetic acid.

Regenerative endodontic treatment was performed in two visits. During the first visit, the root canal was initially irrigated with 1.5% sodium hypochlorite. The allocated OCT or EDTA solution was then applied and ultrasonically activated. Calcium hydroxide was placed as an intracanal medicament, and the access cavity was temporarily sealed.

The second visit was performed approximately two weeks later. After removal of the intracanal medicament, the root canal was irrigated again according to the allocated protocol, and the irrigant was ultrasonically activated. Apical bleeding was induced to create an intracanal blood clot. Biodentine was placed over the blood clot as a coronal barrier, and the tooth was permanently restored with resin composite.

The primary outcome was postoperative pain intensity, which was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from day 2 through day 7 after the second treatment visit. Secondary outcomes included analgesic consumption and the occurrence of flare-up, defined as severe postoperative pain and/or swelling requiring an unscheduled clinical visit.

Typ studie

Intervenční

Zápis (Aktuální)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Kayseri
      • Kayseri, Kayseri, Turecko (Türkiye), 38039
        • Erciyes Üniversitesi Diş Hekimliği Fakültesi

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • Systemically healthy status classified as American Society of Anesthesiologists class I;
  • An immature permanent tooth with pulp necrosis and apical periodontitis;
  • Cvek stage 2 or 3 root development;
  • Preoperative pain below 40 on a 0-100 numerical rating scale (NRS);
  • A baseline Periapical Index (PAI) score between 2 and 4;
  • A tooth considered restorable and suitable for RET; and
  • Willingness of the participant and legal representative to comply with postoperative assessment and follow-up requirements.

Exclusion Criteria:

  • systemic disease
  • bruxism or another parafunctional habit
  • had used analgesics within 12 hours before treatment
  • severe root canal curvature
  • vertical root fracture

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 17% Ethylenediaminetetraacetic Acid (EDTA)
Participants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 17% ethylenediaminetetraacetic acid (EDTA) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups.
Regenerative endodontic treatment was performed using either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) as the allocated irrigation solution. In both groups, 20 mL of the assigned irrigant was applied for 5 minutes during each treatment visit and ultrasonically activated for 1 minute.
Aktivní komparátor: 0.1% Octenidine Dihydrochloride (OCT)
Participants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 0.1% octenidine dihydrochloride (OCT) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups.
Regenerative endodontic treatment was performed using either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) as the allocated irrigation solution. In both groups, 20 mL of the assigned irrigant was applied for 5 minutes during each treatment visit and ultrasonically activated for 1 minute.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative Pain Intensity Measured Using a Numerical Rating Scale
Časové okno: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Postoperative pain intensity was self-recorded by participants using a numerical rating scale ranging from 0 to 100, where 0 indicated no pain and 100 indicated the worst pain imaginable. Higher scores indicated greater postoperative pain intensity. Pain scores were recorded after the second regenerative endodontic treatment visit.
At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative Analgesic Consumption
Časové okno: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Participants were instructed to use paracetamol only when postoperative pain persisted. A dose of 250 to 500 mg was recommended according to the participant's age and body weight. The number of paracetamol tablets taken at each assessment time was recorded as 0, 1, or 2. Higher values indicated greater analgesic consumption.
At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. října 2025

Primární dokončení (Aktuální)

8. května 2026

Dokončení studie (Aktuální)

8. května 2026

Termíny zápisu do studia

První předloženo

20. července 2026

První předloženo, které splnilo kritéria kontroly kvality

20. července 2026

První zveřejněno (Aktuální)

23. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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