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Effectiveness of Three Different Irrigation Methods During a Root Canal Treatment

25 luglio 2026 aggiornato da: Haroon Hafeez, Pakistan Institute of Medical Sciences

Effect of Various Irrigant Activation Methods and Its Penetration in the Apical Third of Root Canal

This study aims to compare the effectiveness of three root canal irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle (SVN), and Ultrasonic Irrigation (UI)-in achieving irrigant penetration into the apical third of the root canal. Since conventional irrigation often fails to adequately clean complex root canal anatomy, the study evaluates whether activation methods improve irrigant penetration. A randomized controlled trial will compare these three techniques using extracted single-rooted mandibular premolars. A radiopaque dye mixed with sodium hypochlorite will be used to measure irrigant penetration on digital radiographs, and the results will be statistically analyzed to determine the most effective irrigation method.

Panoramica dello studio

Descrizione dettagliata

This study focuses on evaluating the effectiveness of three different root canal irrigation techniques in achieving irrigant penetration into the apical third of the root canal. Successful root canal treatment depends not only on mechanical instrumentation but also on adequate irrigation to eliminate bacteria, dissolve organic tissue, and remove debris from areas that instruments cannot reach. Due to the complex anatomy of the root canal system, studies have shown that nearly 35% of the canal walls remain untouched after instrumentation. Therefore, irrigation plays a vital role in ensuring complete disinfection of the canal system. Furthermore, bacteria are capable of penetrating 300-500 micrometers into the dentinal tubules, making it essential for the irrigant to reach as deep as possible within the canal.

Conventionally, sodium hypochlorite is delivered into the canal using a syringe and needle. Although it is considered the gold standard irrigant because of its tissue-dissolving ability and broad-spectrum antimicrobial action, conventional needle irrigation has limitations. The irrigant generally does not travel beyond the tip of the needle, leaving the apical third and other complex areas inadequately cleaned. To overcome these shortcomings, newer irrigation activation methods such as side-vented needles and ultrasonic irrigation have been introduced to improve irrigant flow and penetration throughout the root canal system.

The purpose of this study is to compare three irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), and Ultrasonic Irrigation (UI)-to determine which technique provides the deepest penetration of the irrigant into the apical third of the root canal. The hypothesis of the study is that ultrasonic irrigation, being an active irrigation technique, will result in significantly greater irrigant penetration than conventional needle irrigation and side-vented needle irrigation.

According to the synopsis, this study is designed as a randomized controlled trial and will be conducted in the Department of Operative Dentistry over a period of one year after approval. A total sample size of 105 teeth will be included, with 35 samples allocated to each of the three study groups. The study will include extracted single-rooted mandibular first and second premolars with straight canals and closed apices, while teeth with open apices, curved canals, or calcified canals will be excluded.

Initially, all selected teeth will be examined radiographically to exclude unsuitable samples. Standard access cavity preparation will then be carried out, followed by determination of the working length. The canals will be instrumented using the ProTaper rotary system up to file F3, while sodium hypochlorite will be used as the irrigating solution during instrumentation. After completion of canal preparation, the samples will be randomly assigned to one of the three irrigation groups: Conventional Needle Irrigation, Side-Vented Needle Irrigation, or Ultrasonic Irrigation.

To assess irrigant penetration, a radiopaque iohexol dye will be mixed with sodium hypochlorite. After irrigation using the assigned technique, digital radiographs will be obtained. The distance from the apical foramen to the deepest point reached by the radiopaque irrigant will be measured for each sample. This measurement will represent the depth of irrigant penetration achieved by each irrigation technique.

The collected data will be entered into Microsoft Excel and analyzed using SPSS version 23. Descriptive statistics, including the mean and standard deviation, will be calculated to compare the irrigant penetration among the three groups. Based on the study hypothesis, ultrasonic irrigation is expected to demonstrate the greatest penetration into the apical third of the root canal, suggesting that it may provide superior canal disinfection compared with conventional and side-vented needle irrigation. This expectation reflects the hypothesis stated in the synopsis rather than study results, as the research has not yet been conducted.

Tipo di studio

Interventistico

Iscrizione (Stimato)

105

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.

Contatto studio

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

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Straight Canals
  • Single Rooted 1st and 2nd mandibular premolars with closed apices

Exclusion Criteria:

  • Mandibular premolars with open apices
  • Mandibular premolars with curved or calcified canals

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Conventional Needle Irrigation
Participants in this group will receive root canal irrigation using a conventional 27-gauge syringe needle. The irrigant, consisting of a radiopaque iohexol dye mixed with 5.25% sodium hypochlorite, will be delivered into the prepared root canal using the conventional needle irrigation technique. Irrigant penetration into the apical third will be assessed using digital radiographs.
Conventional syringe irrigation will be performed using a 27-gauge needle to deliver the radiopaque sodium hypochlorite solution into the prepared root canal. No additional activation technique will be used during irrigation
Comparatore attivo: Side Vented Needle Irrigation
Participants in this group will receive root canal irrigation using a side-vented irrigation needle. The radiopaque irrigant solution, prepared by mixing iohexol dye with 5.25% sodium hypochlorite, will be delivered into the canal using the side-vented needle technique. Irrigant penetration into the apical third will be measured on digital radiographs.
Irrigation will be carried out using a side-vented needle to introduce the radiopaque sodium hypochlorite solution into the prepared canal. The side-vented design is intended to improve irrigant distribution within the canal while minimizing direct apical flow
Sperimentale: Ultrasonic Irrigation
Participants in this group will receive ultrasonic irrigation following completion of canal preparation. A radiopaque irrigant solution consisting of iohexol dye mixed with 5.25% sodium hypochlorite will be ultrasonically activated within the root canal. Digital radiographs will be used to measure the depth of irrigant penetration into the apical third and compare it with the other irrigation techniques
Following canal preparation, the radiopaque sodium hypochlorite solution will be activated using an ultrasonic device to enhance irrigant movement throughout the root canal system before radiographic evaluation of penetration depth.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depth of irrigant penetration into the apical third of the root canal (measured in millimeters).
Lasso di tempo: 5 months
The primary outcome is the depth of penetration of a radiopaque irrigant solution into the apical third of the root canal following irrigation with Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), or Ultrasonic Irrigation (UI). Penetration depth will be measured on digital radiographs as the distance from the apical foramen to the deepest point reached by the irrigant.
5 months

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Haroon H Panezai, BDS, School Of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad

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 (Stimato)

12 luglio 2026

Completamento primario (Stimato)

10 novembre 2026

Completamento dello studio (Stimato)

26 dicembre 2026

Date di iscrizione allo studio

Primo inviato

22 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 luglio 2026

Primo Inserito (Effettivo)

28 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SOD/ERB/2025/89

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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