This prospective, randomized, controlled, single-blind, parallel-group clinical trial evaluates whether intracanal cryotherapy reduces postoperative pain and inflammatory biomarker levels following single-visit endodontic retreatment of teeth with asymptomatic apical periodontitis. A total of 100 patients (18-65 years, systemically healthy, ASA I-II) requiring non-surgical retreatment of a single-rooted mandibular premolar tooth will be randomly assigned via computer-generated randomization to one of two equal groups (n=50 each): a cryotherapy group, receiving intracanal final irrigation with sterile saline cooled to 2.5°C for 5 minutes, and a control group, receiving the same irrigation protocol with saline at room temperature (20-22°C). Salivary nerve growth factor (NGF) and gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels will be measured by ELISA at baseline (T0), 24 hours (T1), and 72 hours (T2). Postoperative pain will be assessed using a visual analog scale (VAS, 0-100 mm) at 6, 12, 24, 48, and 72 hours and on day 7, with the 24-hour VAS score as the primary comparison point. Rescue analgesic (paracetamol) consumption will also be recorded and compared between groups. The study aims to determine whether intracanal cryotherapy lowers postoperative pain and biomarker levels compared to standard-temperature irrigation, and to evaluate the correlation between PGE2/NGF levels and pain intensity.
Inclusion Criteria:
Exclusion Criteria:
hatice.ozkan@alanya.edu.tr
Laboratory personnel analyzing saliva and GCF samples (PGE2, NGF via ELISA), as well as the statisticians performing data analysis, will be blinded to group allocation. The treating clinician cannot be blinded due to the nature of the intervention (irrigation temperature).
Following standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) cooled to 2.5°C, 20 mL, over 5 minutes, in a single visit.
Following the same standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) at room temperature (20-22°C), 20 mL, over 5 minutes, in a single visit.
pelin.yoldas@alanya.edu.tr+90 5462446097
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