Cryotherapy after retreatment of a tooth: does cooling the canal reduce pain and inflammation?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind, parallel-group study enrolls 100 systemically healthy adults aged 18-65 undergoing non-surgical retreatment of a single-rooted mandibular premolar with asymptomatic apical periodontitis. Participants are assigned to either intracanal cryotherapy with 2.5°C sterile saline for 5 minutes or the same irrigation at room temperature. The study measures pain using a visual analog scale and collects salivary nerve growth factor (NGF) and gingival crevicular fluid prostaglandin E2 (PGE2) at baseline, 24 hours, and 72 hours post-treatment. The primary aim is to see if cooling the canal lowers pain and inflammatory mediator levels compared with standard irrigation. The trial uses computer-generated randomization and sealed envelopes to ensure allocation concealment, with outcome assessment conducted in the context of routine endodontic retreatment care.

Why it matters

Who can join: the full rules

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

Where it's running

• Alanya Alaaddin Keykubat University
  Alanya, Antalya, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Bilge Karcı, Associate Professor — Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology
• Study coordinator: Hatice Büyüközer Özkan, Associate Professor
• Email: hatice.ozkan@alanya.edu.tr
• Phone: +90 530 971 02 52

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.