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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2025-06-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Cryotherapy Group

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.

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

In the cryotherapy group, the pulp chamber was irrigated with 5 mL of sterile saline solution pre-cooled to 2.5°C during full pulpotomy.

Dexamethasone Group

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.

Group Type EXPERIMENTAL

Dexametasone

Intervention Type DRUG

In the dexamethasone group, the pulp chamber was irrigated with 2 mL of dexamethasone sodium phosphate solution (4 mg/mL) during full pulpotomy.

Interventions

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Cryotherapy

In the cryotherapy group, the pulp chamber was irrigated with 5 mL of sterile saline solution pre-cooled to 2.5°C during full pulpotomy.

Intervention Type OTHER

Dexametasone

In the dexamethasone group, the pulp chamber was irrigated with 2 mL of dexamethasone sodium phosphate solution (4 mg/mL) during full pulpotomy.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No