About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years, systemically healthy individuals (ASA I-II)
Single-rooted mandibular premolar teeth with a previous root canal treatment, requiring non-surgical retreatment due to asymptomatic apical periodontitis
Presence of periapical radiolucency (Periapical Index [PAI] ≥ 3)
No antibiotic use within the past 1 month
Disqualifiers
Pregnancy or lactation
Uncontrolled diabetes mellitus (HbA1c > 7%), diagnosed autoimmune disease, or receiving immunosuppressive therapy
Systemic corticosteroid use within the past 3 months
Body mass index (BMI) greater than 35 kg/m²
Trial design
Parallel
Treatments tested in this trial
Intracanal cryotherapy
Procedure/SurgeryFinal 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
Procedure/SurgeryFinal 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.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain intensity (VAS score)
Postoperative pain intensity assessed using a Visual Analog Scale (VAS, 0-100 mm, where 0 = no pain and 100 = worst imaginable pain), self-reported by patients. The 24-hour time point is designated as the primary comparison between the cryotherapy and control groups.
Secondary outcomes
Salivary nerve growth factor (NGF) levels
Salivary NGF concentration measured by ELISA to assess the neurotrophic/inflammatory biomarker response between cryotherapy and control groups.
Gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels
PGE2 concentration in gingival crevicular fluid measured by ELISA to assess the inflammatory biomarker response between cryotherapy and control groups.
Other outcomes
Rescue analgesic (paracetamol) consumption
Number of rescue analgesic (paracetamol 500 mg, oral) tablets consumed by patients as needed over the follow-up period, compared between groups.
Total rescue analgesic dose consumed
Total cumulative dose of rescue analgesic (paracetamol, oral, as needed) consumed by patients, expressed in milligrams, compared between groups.
Sponsors and contacts
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