Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment

NCT07733700 · tracked via the Priya Life Science Turkey tracker

Sponsor

Alanya Alaaddin Keykubat University

Phase

Not applicable

Started

2026-08-01

Last updated

2026-07-29

Condition(s) studied

Asymptomatic Apical PeriodontitisEndodontic RetreatmentCryotherapy

Investigational drug(s) / intervention(s)

Intracanal cryotherapyRoom-temperature saline irrigation

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Postoperative pain intensity (VAS score) — Baseline, then at 6, 12, 24, 48, and 72 hours and on Day 7 postoperatively (primary comparison at 24 hours)
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.

Trial sites (1)

Facility	City	Region	Status
Alanya Alaaddin Keykubat University, Faculty of Dentistry	Antalya	ALANYA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07733700 on ClinicalTrials.gov ↗ ← All trials in Turkey