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Completed

NCT Number: NCT07710833

Effect of Intracanal Cryotherapy on Postoperative Endodontic Pain

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics

Rize, Centre, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

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.

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: During the first week after treatment

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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