The Effect of Dexamethasone in Full Pulpotomy on Postoperative Pain in Permanent Molars

Not Applicable

Completed

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

• Registration Number: NCT07233577
• 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 full pulpotomy procedures in permanent molars with symptomatic irreversible pulpitis. The main question it aims to answer is:

* Does controlled irrigation with cold saline in full pulpotomy reduce the severity of postoperative pain?

* Does controlled irrigation with dexamethasone in full pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone group, the pulp chambers were irrigated with 2 °C salin solution in final irrigation.

In the dexamethasone group, unlike the control and cryotherapy group, the pulp chambers were irrigated with 2 mL dexamethasone solution in final irrigation.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-18
• Primary Completion: 2025-05-05
• Study Completion: 2025-06-16
• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-18
• Last Update Posted: 2025-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Vital permanent molars showing positive responses to both the cold test and the electric pulp test, with a prolonged cold response (>30 seconds) consistent with symptomatic irreversible pulpitis.
• Presence of deep carious lesions in the included teeth (indicated for vital pulp therapy).
• No radiographic evidence of periapical pathology (i.e., no periapical radiolucency, root resorption, or pathological widening of the periodontal ligament space).
• Patients who had not taken analgesics or antibiotics in the last 24 hours before the procedure were included in the study.

Exclusion Criteria

• Devital permanent molars that responded negatively to cold tests and electric pulp tests
• Permanent molars with poor periodontal status (pocket depth > 4 mm),
• Teeth that exhibited periapical radiolucency, pathological mobility, or were deemed non-restorable
• Systemic diseases, pregnancy or lactation, known allergies to dexamethasone or NSAIDs, recent use of analgesics (within 24 hours), and any contraindications for pulpotomy or local anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy Group	Cryotherapy	5 mL of sterile saline solution pre-cooled to 2.5°C was administered into the pulp chamber using the same technique. This solution was also left in contact with the pulp tissue for 5 minutes, without aspiration, to provide localized cold exposure. The cold saline was stored in a calibrated medical cooler and monitored with a digital thermometer to ensure consistent temperature throughout the clinical procedure.
Dexamethasone Group	Dexametasone	The pulp chamber was irrigated with 2 mL of a dexamethasone sodium phosphate solution at a concentration of 4 mg/mL (Decort®, DEVA Holding, Türkiye). The solution was delivered slowly into the pulp chamber using a sterile syringe with a blunt needle tip and left in place for 1 minutes to allow direct contact with the exposed radicular pulp tissue. Afterward, the chamber was dried gently with sterile cotton pellets.

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 (Türkiye)