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NOT YET RECRUITING
NCT07403578
NA

Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis

Sponsor: TC Erciyes University

View on ClinicalTrials.gov

Summary

This prospective randomized clinical trial aimed to evaluate the effects of different anesthesia protocols on anesthetic success and intraoperative pain during root canal treatment of mandibular premolars diagnosed with symptomatic irreversible pulpitis. A total of 100 systemically healthy patients were randomly allocated into four groups: infiltration anesthesia alone, inferior alveolar nerve block (IANB) alone, infiltration anesthesia combined with cryotherapy, and IANB combined with cryotherapy. Cryotherapy was applied intraorally for 5 minutes immediately after anesthetic administration. The effectiveness of anesthesia was confirmed using electric pulp testing and cold testing prior to treatment. Root canal therapy was completed in a single visit by a calibrated operator. Intraoperative pain was assessed during access cavity preparation using a visual analogue scale (VAS). Anesthetic success was defined as the presence of no or mild pain, whereas moderate or severe pain indicated anesthetic failure and required supplemental anesthesia. The primary objective of the study was to determine whether the adjunctive use of cryotherapy improves anesthetic success and reduces intraoperative pain in mandibular premolars with symptomatic irreversible pulpitis. The null hypothesis was that no significant differences would be observed among the study groups in terms of anesthetic success or intraoperative pain intensity.

Official title: Effect Of Cryotherapy On Anesthetıc Success And Intraoperatıve Paın In Mandıbular Premolars Wıth Irreversıble Pulpıtıs: A Prospectıve Randomızed Clınıcal Trıal

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-30

Completion Date

2026-12-30

Last Updated

2026-02-11

Healthy Volunteers

Yes

Interventions

PROCEDURE

infiltration anesthesia alone

Local anesthesia was achieved using buccal infiltration with 2% lidocaine and 1:100,000 epinephrine.

PROCEDURE

mandibular anesthesia alone

Local anesthesia was achieved using mandibular block anesthesia with 2% lidocaine and 1:100,000 epinephrine.

PROCEDURE

infiltration anesthesia combined with cryotherapy

Cryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication

PROCEDURE

mandibular anesthesia combined with cryotherapy

Cryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication