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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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. In this study, we will examine its effect in a defined group of patients and explore how it works. We will measure the level of irisin, a substance with reported anti-inflammatory properties, in saliva to see whether cryotherapy changes it. We 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 their 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 it change salivary irisin levels? Does pain catastrophizing change the effect of cryotherapy? Is dental anxiety related to pain after treatment?

Eligibility

Primary outcome measure(s)

• Postoperative Pain as Assessed by Visual Analog Scale (VAS) — 24 hours after root canal treatment
  Postoperative pain will be self-assessed by participants using a 100 mm Visual Analog Scale (VAS), consisting of a horizontal line where participants mark the point that best represents their level of pain intensity. The left end (0 mm) indicates "no pain" and the right end (100 mm) indicates "the most severe pain I have ever felt in my life." Scores are measured in millimeters, with higher scores indicating greater pain intensity. Participants will record their VAS score in a standardized pain diary at each assessment time point, along with any rescue analgesic (paracetamol 500 mg) use, including time and dose, and any adverse events or unexpected occurrences. A blinded researcher, unaware of group allocation, will telephone participants at each designated time point to record pain scores and remind them to complete the diary.

Trial sites (1)

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