Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis; Cryotherapy
• Intervention / Treatment: Procedure: infiltration anesthesia alone; Procedure: infiltration anesthesia combined with cryotherapy; Procedure: mandibular anesthesia alone; Procedure: mandibular anesthesia combined with cryotherapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşe Tuğba Eminsoy Avcı, Dentist; Phone Number: +905468725480; Email: dtaysetugbaeminsoy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Systemically healthy patients classified as ASA I or II, aged between 18 and 60 years,
• Presence of a restorable mandibular premolar tooth diagnosed with symptomatic irreversible pulpitis,
• History of spontaneous pain or lingering pain elicited by thermal stimuli,
• Positive response with lingering pain to cold testing (Endo Ice; Coltene, Altstätten, Switzerland),
• Positive response at low current levels to electric pulp testing (Parkell Inc., USA),
• Teeth with closed apex and no radiographic evidence of periapical pathology (intact periodontal ligament space and absence of periapical radiolucency),
• Patients presenting with moderate or severe preoperative pain, as assessed using the visual analogue scale (VAS).

Exclusion Criteria:

• Patients who had taken analgesic, anti-inflammatory, or opioid medication within the last 12 hours before treatment,
• Patients with systemic conditions that may affect pain perception, inflammatory response, or healing,
• History of antibiotic use within the previous month or requirement for antibiotic prophylaxis,
• Teeth presenting with clinical or radiographic signs of pulp necrosis or apical periodontitis (Pain on percussion or palpation, presence of sinus tract or swelling, presence of periapical radiolucency),
• Teeth with root resorption, immature apices, severe coronal destruction preventing proper isolation, or calcified canals,
• Teeth that had undergone previous endodontic treatment, including pulpotomy or root canal filling,
• Patients with neurological or psychiatric conditions that could interfere with pain perception or accurate pain reporting,
• Inability to achieve adequate isolation with a rubberdam.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: infiltration anesthesia	Procedure: infiltration anesthesia alone; Local anesthesia was achieved using buccal infiltration 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
Experimental: mandibular anesthesia	Procedure: mandibular anesthesia alone; Local anesthesia was achieved using mandibular block anesthesia with 2% lidocaine and 1:100,000 epinephrine.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative pain	Intraoperative pain intensity assessed using a Visual Analogue Scale (VAS) (1-10) during access cavity preparation.	Baseline/During the Operation

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Cryotherapy; Anesthesia, Local
• Other Study ID Numbers: 02

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