Effect of Intracanal Cryotherapy on Postoperative Pain

NCT06764823 | Completed

• 1 other identifier: KUTAHYAHSU-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: Since 1960, cryotherapy, involving the application of cold, has been used in various fields of medicine for pain treatment. Cold application induces three main physiological tissue responses: a decrease in metabolic activity, a reduction in blood flow, and the inhibition of neural receptors in the skin and subcutaneous tissues. Consequently, cryotherapy slows down neural signals and reduces the release of chemical mediators responsible for pain. Recently, the use of cryotherapy in root canal treatment, in the form of cold saline irrigation, has been investigated in several randomized controlled trials. The aim of this study is to evaluate the effect of cold saline irrigation as a final irrigant on postoperative pain following the biomechanical preparation of root canals in patients undergoing non-surgical retreatment. Method: Sixty single-rooted, single-canal teeth requiring non-surgical root canal retreatment were randomly assigned to two groups (n = 30): a cryotherapy group and a control group. All the treatments were completed during a single visit. Protaper Universal Retreatment files (D1, D2, and D3) were used for the removal of gutta-percha and root canal preparation, and irrigation was performed using 2.5 % NaOCl and 17% EDTA. The cryotherapy group had a final irrigation temperature of 2.5 °C for 5 min before root canal obturation, whereas the control group received irrigation at room temperature. All patients will be asked to record their postoperative pain levels on VAS scales at 6, 12, and 24 hours, and at 2, 3, and 7 days after treatment. Patients will be asked to rate the pain they experience during the 7-day postoperative period on a scale from 0 to 10. Statistical analysis was performed using the Chi-Square test, Mann-Whitney test, and Independent Samples test, with the significance level set at 0.05.

Conditions

Retreatment; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Radiographic assessment of retreatment success

  The quality of endodontic treatment will be evaluated according to the criteria established by Cleen et al.: (a) Adequate: Root canal filling 0-2 mm short of the radiographic apex. (b) Inadequate: Root canal filling more than 2 mm short of the radiographic apex. (c) Inadequate: Root canal filling extending beyond the radiographic apex. The density of the root canal treatment will be assessed based on the criteria of Dugas et al.: (a) Adequate: Uniform radiopacity and tight adaptation of gutta-percha to the root canal walls. (b) Inadequate: Visible voids in the root canal or unfilled canals. For the retreatment to be considered successful, it must be rated as adequate according to both of the above criteria.

  "0 hours" (Treatment appointment)

Secondary Outcomes (1)

• Post-operative pain

  6., 12., 24. hours and 2., 3. and 7. day

Study Arms (2)

Cryotherapy

EXPERIMENTAL

The final irrigation solution will be 5 mL of 0.9% physiological saline solution at 2.5°C, irrigated for 5 minutes.

Other: Cryotherapy

Control

OTHER

The final irrigation for the control group will be 5 mL of 0.9% physiological saline solution at room temperature, irrigated for 5 minutes.

Other: Control

Interventions

Cryotherapy OTHER

In the cryotherapy group, after completing the biomechanical preparation, the root canals will be irrigated with 5 mL of 0.9% physiological saline solution at 2.5°C for 5 minutes; the solution will be stored in the refrigerator until use.

Cryotherapy

Control OTHER

In the control group, the final irrigation will be performed using 5 mL of 0.9% physiological saline solution at room temperature for 5 minutes.

Control

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy individuals
• No analgesic anti-inflammatory medication intake in the last 72 hours
• Age 18-59
• PAI score of 4 (well-defined periapical radiolucency)
• Previous root canal treatment 2-4 mm short
• At least 4 years since the existing root canal treatment
• Asymptomatic acute apical periodontitis requiring retreatment of single-rooted teeth

You may not qualify if:

• Medically compromised patients
• Pregnant patients
• Patients taking analgesic or anti-inflammatory medication
• Patients who refuse to participate
• Patients with an allergy to articaine
• Teeth with internal and external resorption
• Teeth with open apices

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (2)

Kutahya Health Sciences University Faculty of Dentistry

Kütahya, Turkey (Türkiye)

Location

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were not informed about the temperature of the saline solution applied to them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Experimental Group: The final irrigation solution will be 5 mL of 0.9% physiological saline solution at 2.5°C, irrigated for 5 minutes. Control Group: The final irrigation for the control group will be 5 mL of 0.9% physiological saline solution at room temperature, irrigated for 5 minutes.

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 8, 2025
• Study Start: January 3, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

TU (2)