Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: infiltration anesthesia alone, mandibular anesthesia alone, infiltration anesthesia combined with cryotherapy, mandibular anesthesia combined with cryotherapy.
- Who it may be relevant to
- Registry conditions: Irreversible Pulpitis, Cryotherapy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect Of Cryotherapy On Anesthetıc Success And Intraoperatıve Paın In Mandıbular Premolars Wıth Irreversıble Pulpıtıs: A Prospectıve Randomızed Clınıcal Trıal
Overview
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.
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
Primary outcome measures
- Intraoperative pain [Time frame: Baseline/During the Operation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07403578 · 02