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

Çukurova University

Status: Completed

Conditions: Pulpitis - Irreversible

Treatments: Drug: Dexametasone; Other: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07233577

06.12.2024/15

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effects of cryotherapy and dexamethasone on the intensity of postoperative pain in full pulpotomy procedures in permanent molars with symptomatic irreversible pulpitis. The main questions it aims to answer are:

• Does controlled irrigation with cold saline during full pulpotomy reduce the severity of postoperative pain?
• Does controlled irrigation with dexamethasone during full pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone groups, the pulp chamber was irrigated with 2°C saline solution during the final irrigation step.

In the dexamethasone group, unlike the control and cryotherapy groups, the pulp chamber was irrigated with 2 mL dexamethasone solution during the final irrigation step.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vital permanent molars exhibiting 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 during the 24 hours preceding the procedure.

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

Control Group

No Intervention group

Description:

The pulp chamber was irrigated with 5 mL of sterile saline at room temperature (22-25°C). The solution was delivered slowly into the pulp chamber using a sterile syringe with a blunt needle tip and left in place for 5 minutes to allow direct contact with the exposed radicular pulp tissue. Afterward, the chamber was dried gently with sterile cotton pellets.

Cryotherapy Group

Experimental group

Description:

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.

Treatment:

Other: Cryotherapy

Dexamethasone Group

Experimental group

Description:

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 slowly delivered into the pulp chamber using a sterile syringe with a blunt-tipped needle and left in place for 1 minute to allow direct contact with the exposed radicular pulp tissue. Subsequently, the chamber was gently dried with sterile cotton pellets.

Treatment:

Drug: Dexametasone