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

NCT06820996 | Completed DMC

• 1 other identifier: 13.02.2025/150
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis - Irreversible

Keywords

Cryotherapy; Irreversible pulpits; Sodium hypochlorite; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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

Study Arms (4)

Cryotreated %2.5 NaOCl

EXPERIMENTAL

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

Normal %2.5 NaOCl

EXPERIMENTAL

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)

Cryotreated %5 NaOCl

EXPERIMENTAL

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

Normal %5 NaOCl

EXPERIMENTAL

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)

Interventions

Cryotherapy OTHER

The root canals were irrigated with 2 °C NaOCl solution in cryotherapy group.

Also known as: Normal

Cryotreated %2.5 NaOCl; Cryotreated %5 NaOCl

Control (Standard treatment) OTHER

The root canals were irrigated with 25 °C NaOCl solution in normal group.

Normal %2.5 NaOCl; Normal %5 NaOCl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (2)

• Nandakumar M, Nasim I. Effect of intracanal cryotreated sodium hypochlorite on postoperative pain after root canal treatment - A randomized controlled clinical trial. J Conserv Dent. 2020 Mar-Apr;23(2):131-136. doi: 10.4103/JCD.JCD_65_20. Epub 2020 Nov 5.

  PMID: 33384483 BACKGROUND

• Lalfakawmi S, Gupta A, Duraisamy AK, Abraham D, Mrinalini M, Mane AP. Impact of Cryotreated and Warm Sodium Hypochlorite on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial. J Endod. 2024 Nov;50(11):1543-1550. doi: 10.1016/j.joen.2024.07.002. Epub 2024 Jul 8.

  PMID: 38987018 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Koray Yılmaz, DDS MSc

  Cukurova Univercity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cukurova University, Faculty of Dentistry

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: March 18, 2024
• Primary Completion: November 18, 2024
• Study Completion: January 15, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)