Cryotherapy Versus Dexamethasone on Postoperative Pain in Permanent Mandibular Molars

NCT06832254 | Completed DMC

• 1 other identifier: 13.02.2025/151
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to evaluate cryotherapy versus dexamethasone 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 saline in root canal treatment reduce the severity of postoperative pain?
• Does controlled irrigation with dexamethasone in root canal treatment reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone group, the root canals were irrigated with 2 °C salin solution in final irrigation. In the dexamethasone group, unlike the control and cryotherapy group, the root canals were irrigated with 1 mL dexamethasone solution in final irrigation.

Conditions

Pulpitis - Irreversible

Keywords

Cryotherapy; Irrevesible pulpitis; Dexamethasone; 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 (3)

Control Group

NO INTERVENTION

Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of normal saline for 5 minutes.

Cryotherapy Group

EXPERIMENTAL

Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of cold (2 °C) saline for 5 minutes.

Other: Cryotherapy

Dexamethasone Group

EXPERIMENTAL

Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA, 2 mL saline and 1 mL dexamethasone.

Drug: Dexamethasone

Interventions

Cryotherapy OTHER

The root canals were irrigated with 2 °C saline solution in final irrigation in cryotherapy group.

Cryotherapy Group

Dexamethasone DRUG

Each root canal was irrigated with 1 mL dexamethasone solution in final irrigation in dexamethasone group.

Dexamethasone Group

Eligibility Criteria

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

You may qualify if:

• Vital mandibular first and second molars with 3 root canals that responded positively to the cold test and electric pulp test
• Patients who had not taken analgesics or antibiotics in the last 24 hours before the procedure were included in the study.

You may not qualify if:

• Devital mandibular first and second molars that responded negatively to cold tests and electric pulp tests
• Mandibular first and second molars with poor periodontal status (pocket depth \> 4 mm),
• Mandibular first and second molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity were excluded from the study.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (3)

• Rogers MJ, Johnson BR, Remeikis NA, BeGole EA. Comparison of effect of intracanal use of ketorolac tromethamine and dexamethasone with oral ibuprofen on post treatment endodontic pain. J Endod. 1999 May;25(5):381-4. doi: 10.1016/S0099-2399(06)81176-3.

  PMID: 10530266 BACKGROUND

• Solomon RV, Paneeru SP, Swetha C, Yatham R. Comparative evaluation of effect of intracanal cryotherapy and corticosteroid solution on post endodontic pain in single visit root canal treatment. J Clin Exp Dent. 2024 Mar 1;16(3):e250-e256. doi: 10.4317/jced.61023. eCollection 2024 Mar.

  PMID: 38600937 BACKGROUND

• Dildar I, Moghal A, Mirza A, Zaheer MA, Mallick MR, Munir S. Evaluation of Postoperative Pain after Using Dexamethasone Intracanal Rinse in Irreversible Pulpitis. J Coll Physicians Surg Pak. 2024 Apr;34(4):390-393. doi: 10.29271/jcpsp.2024.04.390.

  PMID: 38576278 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cryotherapy; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Koray Yılmaz, DDS MSc

  Cukurova University

  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: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: April 5, 2024
• Primary Completion: December 10, 2024
• Study Completion: January 5, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)