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Completed

NCT Number: NCT06820996

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryotherapy

Other

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

Other names: Normal

Control (Standard treatment)

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Effect of Cryotreated Sodium Hypochlorite Irrigation at Different Consentrations in Mandibular First Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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