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

NCT07233577 | Completed DMC

• 1 other identifier: 06.12.2024/15
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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

Study Arms (3)

Control Group

NO INTERVENTION

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

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

Dexamethasone Group

EXPERIMENTAL

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

Interventions

Cryotherapy 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.

Cryotherapy Group

Dexametasone DRUG

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

Dexamethasone Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (3)

• Dildar I, Moghal A, Mirza A, Zaheer MA, Mallick MR, Munir S. Evaluation of Postoperative Pain after Using Dexamethasone Intracanal Rinse in Irreversible Pulpitis. J Coll Physicians Surg Pak. 2024 Apr;34(4):390-393. doi: 10.29271/jcpsp.2024.04.390.

  PMID: 38576278 BACKGROUND

• Solomon RV, Paneeru SP, Swetha C, Yatham R. Comparative evaluation of effect of intracanal cryotherapy and corticosteroid solution on post endodontic pain in single visit root canal treatment. J Clin Exp Dent. 2024 Mar 1;16(3):e250-e256. doi: 10.4317/jced.61023. eCollection 2024 Mar.

  PMID: 38600937 BACKGROUND

• Rogers MJ, Johnson BR, Remeikis NA, BeGole EA. Comparison of effect of intracanal use of ketorolac tromethamine and dexamethasone with oral ibuprofen on post treatment endodontic pain. J Endod. 1999 May;25(5):381-4. doi: 10.1016/S0099-2399(06)81176-3.

  PMID: 10530266 BACKGROUND

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Koray Yılmaz, DDS, MSc, Professor

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 18, 2024
• Primary Completion: May 5, 2025
• Study Completion: June 16, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)