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Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis

100 participantsStarted 2026-01-30

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraoperative pain

Timeframe: Baseline/During the Operation

Trial details

NCT IDNCT07403578

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Ayşe Tuğba Eminsoy Avcı, Dentist

+905468725480 dtaysetugbaeminsoy@gmail.com

View on ClinicalTrials.gov More Irreversible Pulpitis trials