Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTC Erciyes University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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),
Disqualifiers
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),
Trial design
Design model
Parallel
Treatments tested in this trial
infiltration anesthesia alone
Procedure/SurgeryLocal anesthesia was achieved using buccal infiltration with 2% lidocaine and 1:100,000 epinephrine.
mandibular anesthesia alone
Procedure/SurgeryLocal anesthesia was achieved using mandibular block anesthesia with 2% lidocaine and 1:100,000 epinephrine.
infiltration anesthesia combined with cryotherapy
Procedure/SurgeryCryotherapy 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 combined with cryotherapy
Procedure/SurgeryCryotherapy 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: infiltration anesthesiaExperimental treatment 2 interventions
Group B: mandibular anesthesiaExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Intraoperative pain
Intraoperative pain intensity assessed using a Visual Analogue Scale (VAS) (1-10) during access cavity preparation.
Time frame
Baseline/During the OperationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: