Cryotherapy Versus Dexamethasone on Postoperative Pain in Permanent Mandibular Molars

Not Applicable

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Other: Cryotherapy; Drug: Dexamethasone

• Registration Number: NCT06832254
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-05
• Primary Completion: 2024-12-10
• Study Completion: 2025-01-05
• Status Verified: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Submitted: 2025-03-08
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy Group	Cryotherapy	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.
Dexamethasone Group	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	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.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Sarıçam, Turkey