Effect of Passive Ultrasonic Irrigation Activation Cycle on Postoperative Pain

November 27, 2024 updated by: Esin Özlek

Effect of Different Duration and Number of Passive Ultrasonic Irrigation Activation Cycles on Postoperative Pain in Teeth with Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial

One of the most important goals of root canal treatment is to eliminate bacteria from infected canals. However, conventional irrigation methods combined with mechanical preparation applied during root canal treatment may not be sufficient for optimal disinfection. Various studies have shown that there are areas in the root canal that cannot be reached during chemomechanical shaping. One of the most popular techniques developed to deliver irrigation solutions to these areas is the Passive Ultrasonic Irrigation (PUI) technique, which provides good efficiency in terms of cleaning the root canal system. Activation of NAOCI with ultrasonic systems in the final irrigation significantly reduces the amount of microorganisms in the canal. Although the use of PUI in the final irrigation increases the effectiveness of irrigation solutions and enables the solutions to reach the apical third of the root canal, it causes extrusion of solutions into periapical tissues, albeit in small amounts, due to the positive apical pressure it creates during irrigation, and this causes postoperative pain. Postoperative pain is an undesirable but frequently encountered condition after endodontic treatment. During root canal treatment, extrusion of irrigation solutions or debris from the apex, mechanical, chemical or microbial factors can cause postoperative pain. In one study, the incidence of postoperative pain after endodontic treatment was reported to vary from 3% to 58%. Although the most effective is not yet fully known, when the literature is reviewed, different durations and cycles have been used for PUI. The change in the number of PUI cycles increases the microflow in the root canal, which may increase irrigation extrusion from the apical region and affect postoperative pain. Although many results have been reported in studies comparing the effect of final activation with Passive Ultrasonic Irrigation on postoperative pain with another technique, the activation cycle with PUI was determined as 3 times and 20 seconds each time, and this cycle order remained the same most of the time. Since there is no study in which the differences between cycles in activation with PUI affected postoperative pain, in this study the irrigation solution will be activated with PUI 3 times for 20 seconds and 6 times for 10 seconds, and the postoperative pain created by these two cycle orders will be compared.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

The study is planned to be conducted on 60 patients between the ages of 18-45 who were diagnosed and followed up at the Endodontics Clinic of the Faculty of Dentistry of Van Yuzuncu Yil University. Patients with no systemic disease, diagnosed with irreversible pulpitis, single-rooted and single-canal lower premolar teeth will be included in the case group. Patients with resorption and calcification at the roots of their teeth, incomplete root development, pregnant and breastfeeding, those who have taken analgesics or anti-inflammatory drugs in the last 12 hours, those who have used antibiotics in the last month, and those who cannot use a rubber dam in root canal treatment will not be included in the study. After obtaining the consent form from the patients, local anesthesia (Ultracain DS Fort, Hoechst-Marian Roussel, Frankfurt, Germany) will be applied to the tooth to be treated with root canal treatment. The access cavity will be opened with diamond burs under rubber dam isolation. The working length will be determined using a #10 K file (Mani Inc, Tochigi, Japan) and an electronic apex locator (Propex Pixi, Dentsply Maillefer, Switzerland). The root canals will be shaped to a size 40/0.06 using NiTI rotary files (ProTaper Next; Dentsply Sirona) at 300 rpm and 2 Ncm according to the manufacturer's instructions. The patients will be divided into 3 groups according to the final irrigation activation protocol for root canal treatment: Group 1: Control group. In the final irrigation, NaOCI will be applied with needle irrigation for a total of 60 s. Group 2: PUI 3*20 s. In the final irrigation, NaOCI will be applied with PUI for 3*20 s for a total of 60 s. Group 3: PUI 6*10 s. In the final irrigation, NaOCI will be applied for 60 seconds in total with PUI for 6*10 seconds. 5.25% NaOCI and 17% EDTA will be used as irrigation solution during the shaping process. NaviTip irrigation needle (30-G; Ultradent Products Inc, South Jordan, USA) will be used in the irrigation process during shaping. After the activation process is completed, the canals will be rinsed with distilled water as the final irrigation and the root canals will be filled with gutta percha and Adseal (Meta Biomed, Cheongju, North Korea) root canal sealer using the single cone method. The teeth will be restored with composite. Patients will be prescribed 400 mg ibuprofen anti-inflammatory medication to use in case of severe pain. The pain levels of the patients before and after the procedure will be evaluated with the VAS (Visual Analogue Scale) pain scale. Patients will be given a 10 cm paper ruler to record their pain levels at 6, 12, 24, 48, 72 hours and 1 week. Patients will be instructed on how to score their pain levels and will be asked to mark their pain levels on the ruler at the specified hours. At the end of the 1 week period, the rulers will be collected from the patients and the data will be statistically analyzed and interpreted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy persons between the ages of 18 and 45 years
  • Single-rooted and single-canal mandibular premolars diagnosed with symptomatic irreversible pulpitis

Exclusion Criteria:

  • Patients who are taken analgesic inflammatory drugs with in the last 12 hours
  • Pregnancy or lactation
  • Teeth with calcified canals
  • Teeth with sensitive to percussion and palpation
  • Teeth with root resorption
  • Teeth with immature/open apex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
In the final irrigation, 6 ml of 5.252% NaOCI will be applied with needle irrigation for a total of 60 seconds.
Other: Conventional needle irrigation
Conventional needle irrigation method was applied. As a final irrigation, 6 ml NaOCl was applied with 60 seconds of needle irrigation followed by 60 seconds of rest.
Active Comparator: Passive Ultrasonic Irrigation 3*20 sec
In the final irrigation, 6 ml of 5.25% NaOCI will be applied as 3*20 seconds with PUI for a total of 60 seconds.
Other: Passive Ultrasonic Irrigation with 3*20 sn
In the final irrigation, 6 ml (3×2 ml) NaOCl was activated by PUI for 20 seconds in 3 cycles (60 seconds total). Before each cycle, 2 ml of NaOCl solution was refreshment.
Active Comparator: Passive Ultrasonic Irrigation 6*10 sec
In the final irrigation, 6 ml of 5.25% NaOCI will be applied as 6*10 seconds with PUI for a total of 60 seconds.
Other: Passive Ultrasonic Irrigation with 6*10 sn
For the final irrigation, 6 ml (6×1 ml) NaOCl was activated with PUI for 10 seconds in 6 cycles (60 seconds total). Before each cycle, 1 ml of NaOCl solution was refreshment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Score Scala
Time Frame: The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.
Postoperative pain will be assessed with a visual analog score after endodontic treatment. Scores will be given between 0-10. A score of '0' means no pain, a score of '10' means very severe pain. The higher the score, the higher the pain level.
The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Esin Özlek

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yuzuncu Yıl University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 03/15.11.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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