Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment

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.

Conditions

• Asymptomatic Apical Periodontitis
• Endodontic Retreatment
• Cryotherapy

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University

  lead OTHER

Principal Investigators

• Hatice BÜYÜKÖZER ÖZKAN, Associate Professor · Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Endodontics

• Bilge Karcı, Associate Professor · Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology

• Ertan Küçüksayan, Associate Professor · Alanya Alaaddin Keykubat University, Faculty of Medicine, Department of Biochemistry

• Gizem Pelin Yoldaş, Research Assistant · Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Endodontics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-08-01

Completion

2027-09-01

Countries

• Turkey (Türkiye)

Study Locations