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Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Sponsor: Alanya Alaaddin Keykubat University
Summary
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.
Official title: Evaluation of the Relationship Between PGE2, NGF, and Postoperative Pain in Patients With and Without Intracanal Cryotherapy in Single-visit Endodontic Retreatment
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-08-01
Completion Date
2027-09-01
Last Updated
2026-07-29
Healthy Volunteers
No
Interventions
Intracanal cryotherapy
Final intracanal irrigation with sterile 0.9% saline solution cooled to 2.5°C (using an ice-water bath), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment.
Room-temperature saline irrigation
Final intracanal irrigation with sterile 0.9% saline solution at room temperature (20-22°C), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment - identical protocol to the cryotherapy group except for irrigant temperature.
Locations (1)
Alanya Alaaddin Keykubat University, Faculty of Dentistry
Antalya, ALANYA, Turkey (Türkiye)