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Postoperative Pain After OCT or EDTA Irrigation in Regenerative Endodontic Treatment

20 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Pain Intensity Measured Using a Numerical Rating Scale
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Analgesic Consumption
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2025

Completamento primario (Effettivo)

8 maggio 2026

Completamento dello studio (Effettivo)

8 maggio 2026

Date di iscrizione allo studio

Primo inviato

20 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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