Effect of Cryotreated Sodium Hypochlorite Irrigation At Different Consentrations in Mandibular First Molars

February 12, 2025 updated by: Kübra Gürler, Cukurova University

Effect of Cryotreated Sodium Hypochlorite Irrigation At Different Consentrations in Mandibular First Molars with Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

The goal of this clinical trial was to evaluate the effect of cryotreated sodium hypochlorite solution on the intensity of postoperative pain in root canal treatment procedures in mandibular first molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:

- Does controlled irrigation with cold sodium hypochlorite in root canal treatment reduce the severity of postoperative pain? In the cryotreated NaOCl group, unlike the normal NaOCl group, the root canals were irrigated with 2 °C NaOCl solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Various irrigation solutions that are effective for organic and inorganic tissues are used during root canal treatment. Sodium hypochlorite (NaOCl) is the most commonly used irrigation solution. It has antibacterial and physicochemical properties 20 and is unique in dissolving organic tissues 21. NaOCl irrigation combined with mechanical instrumentation has been consistently shown to substantially reduce the microorganism load in root canals 22. There have been several attempts to increase the antimicrobial efficacy of NaOCl in the root canal system, such as changing its concentration, increasing the contact time with the dentin walls of the root canal, increasing the total volume of irrigation, increasing its temperature, and using manual or mechanical activation methods 3, 23. These methods to increase the efficacy of NaOCl can also result in heightened toxic effects on periapical tissues owing to the tissue-irritating properties of the solution. This extrusion into the periapical region increases postoperative pain, especially in teeth with open apices and necrotic pulps 21, 24. Therefore, instead of using high concentrations of NaOCl, which could increase its toxic effects, safer means, such as increasing its temperature and using it in large volumes, may increase its efficacy 21, 25.

Therefore, ascertaining the clinical impact of cryotreated NaOCl on postoperative pain is essential. The temperature of the irrigation solution is known to affect postoperative pain, and final irrigation with cold saline significantly reduces postoperative pain levels 19, 26. However, studies investigating the effects of cryotreated NaOCl, which is used in all stages of root canal treatment, and using NaOCl at concentrations of 2.5% and 5% on postoperative pain are lacking. This randomized clinical trial investigated the effects of cryotreated 2.5% and 5% NaOCl on postoperative pain during endodontic treatment procedures in mandibular first molars with symptomatic irreversible pulpitis.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • 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 Locations

  • Turkey
    • Sarıçam
      • Adana, Sarıçam, Turkey, 01250
        • Çukurova University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:• Vital mandibular first molars with 3 root canals that responded positively to the cold test and electric pulp test

  • Mandibular first molars with a preoperative VAS value of 4 and above (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), severe pain (7-10 mm))
  • Teeth without periapical radiolucency seen radiographically
  • Patients who did not take analgesics or antibiotics in the last 24 hours before the procedure were included in the study.

Exclusion Criteria:

  • Devital teeth that responded negatively to cold tests and electric pulp tests,
  • Teeth with poor periodontal status (pocket depth > 4 mm),
  • Mandibular first molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity,
  • Teeth with no preoperative pain or with mild preoperative pain (VAS value below 4) were excluded from the study.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryotreated %2.5 NaOCl
A total of 45 ml of 2.5% NaOCl cooled to 2 °C in the refrigerator was placed in 2.5 ml syringes. The syringes were placed in a cold storage box to maintain the temperature during use. The box was filled with ice and the temperature was verified at 2 °C with a digital thermometer. During the root canal preparation, each canal was irrigated with a total of 10 ml of 2.5% NaOCl at 2 °C. The procedure was completed by using 5 ml of 2.5% NaOCl at 2.5 °C, 2 ml of saline, 2 mL of 17% EDTA and 2 ml of saline for each root canal, respectively, as the final irrigation solution.
Other: Cryotherapy
The root canals were irrigated with 2 °C NaOCl solution in cryotherapy group.
Other Names:
  • Normal
Experimental: Normal %2.5 NaOCl
45 milliliters (ml) of 2.5% NaOCl was placed in a glass container at room temperature and the temperature was monitored with a digital thermometer to ensure that it remained at 25 °C. During root canal preparation, each canal was irrigated with a total of 10 ml of 25 °C 2.5% NaOCl. The procedure was completed by using 5 ml of 25 °C 2.5% NaOCl, 2 ml of saline, 2 ml of 17% EDTA and 2 ml of saline for each root canal, respectively, as the final irrigation solution.
Other: Control (Standard treatment)
The root canals were irrigated with 25 °C NaOCl solution in normal group.
Experimental: Cryotreated %5 NaOCl
A total of 45 ml of 5% NaOCl cooled to 2 °C in the refrigerator was placed in 2.5 ml syringes. The syringes were placed in a cold storage box to maintain the temperature during use. The box was filled with ice and the temperature was verified at 2 °C with a digital thermometer. During the root canal preparation, each canal was irrigated with a total of 10 ml of 5% NaOCl at 2 °C. As the final irrigation solution, 5 ml of 5% NaOCl at 2 °C, 2 ml of saline, 2 mL of 17% EDTA and 2 ml of saline were used for each root canal, respectively, to complete the procedure.
Other: Cryotherapy
The root canals were irrigated with 2 °C NaOCl solution in cryotherapy group.
Other Names:
  • Normal
Experimental: Normal %5 NaOCl
45 ml of 5% NaOCl was placed in a glass container at room temperature and the temperature was monitored with a digital thermometer to ensure that it remained at 25 °C. During the root canal preparation, each canal was irrigated with a total of 10 ml of 25 °C 5% NaOCl. As the final irrigation solution, 5 ml of 25 °C 5% NaOCl, 2 ml of saline, 2 ml of 17% EDTA and 2 ml of saline were used for each root canal, respectively, and the procedure was completed.
Other: Control (Standard treatment)
The root canals were irrigated with 25 °C NaOCl solution in normal group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: up to 72 hours
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
up to 72 hours

Collaborators and Investigators

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

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Koray Yılmaz, DDS MSc, Cukurova Univercity

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 (Actual)

March 18, 2024

Primary Completion (Actual)

November 18, 2024

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.02.2025/150

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulpitis - Irreversible

Clinical Trials on Cryotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe