Effect of Intracanal Cryotherapy on Postoperative Endodontic Pain

NCT07710833 | Completed

• 1 other identifier: 12
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effects of cooled and room-temperature NaOCl irrigation on postoperative endodontic pain in single-rooted teeth diagnosed with asymptomatic irreversible pulpitis (AIP) or asymptomatic apical periodontitis (AAP).

Conditions

Periapical Periodontitis; Asymptomatic Irreversible Pulpitis; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time

  During the first week after treatment

Study Arms (4)

GROUP 1- Asymptomatic irreversible pulpitis - control

OTHER

20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C. Final irrigation in Groups 1 was performed using this solution.

Other: root canal treatment and cryotherapy

GROUP 2- Asymptomatic irreversible pulpitis- cryotherapy

EXPERIMENTAL

For Group 2, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator. The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use. A digital thermometer was used to verify that the solution remained at 2 °C. Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds.

Other: root canal treatment and cryotherapy

GROUP 3- Asymptomatic apical periodontitis - control (n=33)

OTHER

20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C. Final irrigation in Groups 1 and 3 was performed using this solution.

Other: root canal treatment and cryotherapy

GROUP 4- Asymptomatic apical periodontitis - cryotherapy

EXPERIMENTAL

For Group 4, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator. The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use. A digital thermometer was used to verify that the solution remained at 2 °C. Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds.

Other: root canal treatment and cryotherapy

Interventions

root canal treatment and cryotherapy OTHER

All endodontic procedures were completed in a single visit by one operator with 6 years of clinical experience. Only 1 tooth per patient was included. Local anesthesia was administered using 2 mL articaine HCl containing 1:100,000 epinephrine. After rubber dam isolation and access cavity preparation, working length was determined using an electronic apex locator and confirmed radiographically. Root canals were prepared with Endoart Smart Gold files to size 40/.04 and, when needed, up to 2 larger sizes according to canal anatomy. Apical patency was maintained 1 mm beyond the working length using a size 10 K-file. Between instruments, canals were irrigated with 2 mL of 2.5% NaOCl using a 30-gauge side-vented needle. NaOCl was ultrasonically activated three times for 20 seconds to aid smear-layer removal. Canals were then irrigated with saline, followed by 5 mL of 17% EDTA for 1 minute.

GROUP 1- Asymptomatic irreversible pulpitis - control; GROUP 2- Asymptomatic irreversible pulpitis- cryotherapy; GROUP 3- Asymptomatic apical periodontitis - control (n=33); GROUP 4- Asymptomatic apical periodontitis - cryotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients with 18-70 years of age
• Single-rooted teeth with a single root canal, diagnosed with either AIP and normal periapical tissues or AAP.
• Pulpal and periapical diagnoses were established according to the American Association of Endodontists (AAE) \[20\] diagnostic terminology. Included teeth were categorized into 2 diagnostic groups: AIP with normal periapical tissues and AAP associated with pulp necrosis. AIP was provisionally diagnosed in teeth with extremely deep caries approximating or reaching the pulp, a positive response to cold testing (Dispodent, Nadu, India), and no clinical symptoms. Periapical radiographs showed a PAI score of 1 without periodontal ligament widening. The diagnosis was confirmed intraoperatively by persistent pulpal bleeding that remained uncontrolled after 10 minutes of application of a sterile cotton pellet moistened with 2.5% sodium hypochlorite. AAP was diagnosed in teeth with a PAI score of ≥3 in the absence of clinical symptoms. None of the included teeth exhibited tenderness to percussion. All periapical radiographs were obtained using a phosphor storage plate system and the paralleling technique (Myray parallel holder, NDental, Imola, Italy) under standardized exposure parameters (70 kV, 8 mA, 0.360 s).

You may not qualify if:

• \) Teeth initially diagnosed with AIP in which pulpal bleeding was controlled within 10 min after access cavity preparation, as these teeth were considered eligible for vital pulp therapy.
• \) Teeth initially diagnosed with AIP in which pulp necrosis was identified after access cavity preparation.
• \) Teeth in which root canal treatment could not be completed in a single visit.
• \) Patients who had taken analgesics within 12 hours before the appointment or antibiotics within the previous month.
• \) Teeth with periodontal probing depths \>3 mm or clinical/radiographic signs of periodontal disease.
• \) Teeth with insufficient coronal tooth structure to allow an adequate ferrule.
• \) Pregnant or breastfeeding patients and patients with systemic conditions or regular medication use that could affect treatment outcomes.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics

Rize, Centre, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of endodontics, research assistant

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: May 11, 2026
• Primary Completion: June 26, 2026
• Study Completion: July 3, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

TU (1)