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Not yet recruiting NCT07731594

Effectiveness of Three Different Irrigation Methods During a Root Canal Treatment

No phase Interventional Three Canal Irrigation Methods and Their Comparison Penetration of Irrigant in the Root Canal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional Needle, Side Vented Needle, Ultrasonic Irrigation.
Who it may be relevant to
Registry conditions: Three Canal Irrigation Methods and Their Comparison, Penetration of Irrigant in the Root Canal. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Conventional Needle
    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
  • Procedure Side Vented Needle
    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
  • Procedure Ultrasonic Irrigation
    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.

Primary outcome measures

  • Depth of irrigant penetration into the apical third of the root canal (measured in millimeters). [Time frame: 5 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07731594 · SOD/ERB/2025/89

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗