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Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment

RecruitingNAAges 18 Years - 65 YearsAllAlanya Alaaddin Keykubat University
NCT07733700 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ho

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Willing to participate and has signed the informed consent form Exclusion Criteria: * 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 * Presence of acute infection (e.g., acute apical abscess or cellulitis) * Conditions precluding retreatment, including advanced periodontal breakdown (clinical attachment loss \> 5 mm), root resorption, perforation, or advanced canal calcification * Absence of an opposing (antagonist) tooth resulting in lack of functional occlusal contact * Diagnosed chronic pain syndrome or currently receiving active psychiatric treatment * Smoking more than 10 cigarettes per day * Use of analgesics or NSAIDs within the past 24 hours * Antibiotic use within the past 1 month
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What it tests

  • Intracanal cryotherapy
  • Room-temperature saline irrigation
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Where

1 site
Alanya Alaaddin Keykubat University
Alanya, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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