Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis

NCT07403578 | Not Yet Recruiting

• 1 other identifier: 02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Irreversible Pulpitis; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Intraoperative pain

  Intraoperative pain intensity assessed using a Visual Analogue Scale (VAS) (1-10) during access cavity preparation.

  Baseline/During the Operation

Study Arms (2)

infiltration anesthesia

EXPERIMENTAL

Procedure: infiltration anesthesia alone; Procedure: infiltration anesthesia combined with cryotherapy

mandibular anesthesia

EXPERIMENTAL

Procedure: mandibular anesthesia alone; Procedure: mandibular anesthesia combined with cryotherapy

Interventions

infiltration anesthesia alone PROCEDURE

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

infiltration anesthesia

mandibular anesthesia alone PROCEDURE

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

mandibular anesthesia

infiltration anesthesia combined with cryotherapy PROCEDURE

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

infiltration anesthesia

mandibular anesthesia combined with cryotherapy PROCEDURE

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

mandibular anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Interventions

Anesthesia, Local; Cryotherapy

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Therapeutics

Central Study Contacts

Ayşe Tuğba Eminsoy Avcı, Dentist

CONTACT

+905468725480; dtaysetugbaeminsoy@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 11, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share