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NOT YET RECRUITING
NCT07889050
NA

Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment

Sponsor: Alanya Alaaddin Keykubat University

View on ClinicalTrials.gov

Summary

Some people feel pain after a root canal treatment. This study will test whether intracanal cryotherapy, a final rinse of the tooth with cold sterile saline, can reduce this pain compared with a room-temperature rinse. Previous studies have suggested that intracanal cryotherapy may reduce pain after root canal treatment. This study will examine the effect of cryotherapy in a defined group of patients and explore how cryotherapy works. The investigators will measure the level of irisin, a substance with reported anti-inflammatory properties, in saliva to see whether cryotherapy changes the irisin level. The study will also look at whether a person's tendency to worry about pain (pain catastrophizing) changes the effect of cryotherapy on pain, and whether dental anxiety is related to pain after treatment. Adults aged 18 to 65 who need root canal treatment on a single-rooted lower premolar tooth will receive standard single-visit treatment. By chance, 100 participants will be placed in a cold-saline group or a room-temperature-saline group. Thirty healthy volunteers will give one saliva sample for comparison. Participants will complete questionnaires before treatment, rate pain over the 7 days after treatment, and give saliva samples for irisin measurement. The main questions this study aims to answer are: Does intracanal cryotherapy lower pain after root canal treatment? Does intracanal cryotherapy change salivary irisin levels? Does pain catastrophizing change the effect of cryotherapy on pain? Is dental anxiety related to pain after treatment?

Official title: Evaluation of Postoperative Pain, Pain Catastrophizing, Dental Anxiety, and Salivary Irisin Levels in Patients With and Without Intracanal Cryotherapy Application During Single-Visit Root Canal Treatment

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-11-01

Completion Date

2028-02-15

Last Updated

2026-10-28

Healthy Volunteers

Yes

Interventions

PROCEDURE

Intracanal cryotherapy

Following completion of the standard EndoVac irrigation protocol, a group-specific final irrigation step will be performed. Sterile saline solution, refrigerated at +2°C and further cooled to 2.5°C in an ice-water bath, with temperature verified using a digital thermometer, will be delivered using the EndoVac system. A total of 20 mL of cooled saline will be applied over 5 minutes, with the micro-cannula positioned at working length to ensure effective delivery of the cold irrigant to the apical region via negative pressure.

PROCEDURE

Standard room-temperature irrigation

Following completion of the standard EndoVac irrigation protocol, a group-specific final irrigation step will be performed. Sterile saline solution prepared at room temperature (20-22°C) will be delivered using the EndoVac system, following the same protocol as the intervention group. A total of 20 mL of room-temperature saline will be applied over 5 minutes, using the same technique and duration.

Locations (1)

Alanya Alaaddin Keykubat University, Faculty of Dentistry

Antalya, Antalya, Turkey (Türkiye)