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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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
January 30, 2026
Primary Completion Date
September 30, 2026
Completion Date
December 30, 2026
Last Updated
February 11, 2026
100
ESTIMATED participants
infiltration anesthesia alone
PROCEDURE
mandibular anesthesia alone
PROCEDURE
infiltration anesthesia combined with cryotherapy
PROCEDURE
mandibular anesthesia combined with cryotherapy
PROCEDURE
Lead Sponsor
TC Erciyes University
NCT07410780
NCT07290049
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07130760