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

November 19, 2025 updated by: Kübra Gürler, Cukurova University

The Effect of Dexamethasone in Full Pulpotomy on Postoperative Pain in Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Sarıçam
      • Adana, Sarıçam, Turkey (Türkiye), 01250
        • Çukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Other: 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.
Experimental: 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.
Drug: Dexametasone
In the dexamethasone group, the pulp chamber was irrigated with 2 mL of dexamethasone sodium phosphate solution (4 mg/mL) during full pulpotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 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.
up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Koray Yılmaz, DDS, MSc, Professor, Çukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Actual)

May 5, 2025

Study Completion (Actual)

June 16, 2025

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.12.2024/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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