Effect of Intracanal Cryotherapy on Postoperative Endodon... | NCT07710833

NCT07710833

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time		During the first week after treatment

Eligibility Module

Eligibility Criteria

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.

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.

ID	Term
D010483	Periapical Diseases
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D010510	Periodontal Diseases