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COMPLETED

NCT07710833

Effect of Intracanal Cryotherapy on Postoperative Endodontic Pain

Sponsor: Recep Tayyip Erdogan University

View on ClinicalTrials.gov

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).

Official title: Effect of Intracanal Cryotherapy on Endodontic Postoperative Pain in Teeth With Asymptomatic Irreversible Pulpitis and Asymptomatic Apical Periodontitis: A Four-Arm Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2026-05-11

Completion Date

2026-07-03

Last Updated

2026-07-17

Healthy Volunteers

Conditions

Periapical Periodontitis Asymptomatic Irreversible Pulpitis Cryotherapy

Interventions

OTHER

root canal treatment and cryotherapy

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.

Inclusion Criteria: 1. Systemically healthy patients with 18-70 years of age 2. 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). Exclusion Criteria: 1) Teeth with canal calcification, complex or atypical canal anatomy, root resorption, incomplete root development, or a history of endodontic treatment of the study tooth. 2\) 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. 3\) Teeth initially diagnosed with AIP in which pulp necrosis was identified after access cavity preparation. 4\) Teeth in which root canal treatment could not be completed in a single visit. 5\) Patients who had taken analgesics within 12 hours before the appointment or antibiotics within the previous month. 6\) Teeth with periodontal probing depths \>3 mm or clinical/radiographic signs of periodontal disease. 7\) Teeth with insufficient coronal tooth structure to allow an adequate ferrule. 8\) Pregnant or breastfeeding patients and patients with systemic conditions or regular medication use that could affect treatment outcomes.

Locations (1)

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics

Rize, Centre, Turkey (Türkiye)