Effect of Two Different Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain

N/ANot Yet RecruitingNCT07676409

Cairo University45 enrolled

Overview

The aim of this study is to evaluate the effect of intracanal cryotreated (2-3°C) 2.5% sodium hypochlorite and Saline used throughout the procedure, compared with a room-temperature irrigation protocol with a final cryotreated saline flush or an entirely room temperature irrigation protocol, on postoperative pain in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis in mandibular molars.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Cryotherapy

Interventions

Full Cryotherapy Irrigation (FC)PROCEDURE

Full intracanal irrigation performed using 2.5% cold sodium hypochlorite solution (2-3°C) throughout the treatment procedure, followed by cold saline (2-3°C), EDTA, and a final rinse with cold saline

Final Flush Cryotherapy Irrigation (FFC)PROCEDURE

Full intracanal irrigation performed using 2.5% sodium hypochlorite solution at room temperature throughout the treatment procedure, followed by saline and EDTA at room temperature, and a final rinse with cryotreated saline (2-3°C).

Conventional Irrigation (CI)PROCEDURE

Full intracanal irrigation performed at room-temperature using 2.5% sodium hypochlorite solution, followed by saline, EDTA, and a final rinse with saline.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 20-40 years old. 2. Systemically healthy patients (ASA I or II). 3. Mature Mandibular molar teeth with : * Preoperative sharp pain and symptomatic apical periodontitis marked on NRS scale by reading not less than 6. * Absence or slight widening in the periodontal ligament (PDL). * Vital response of pulp tissue to cold pulp tester and (ethyl chloride spray). * Positive response to percussion test. 4. Restorable teeth. 5. Ability to complete the endodontic treatment in a single visit. 6. Positive patient acceptance for participation in the trial. ----------------------------------------------------------------- Exclusion Criteria: 1. Medically compromised patients (ASA III or IV) 2. Patients who used NSAIDs in the 24 hours before treatment. 3. Patients with two or more adjacent teeth requiring endodontic treatment. 4. Pregnant women. 5. Patients reporting bruxism or clenching. 6. Teeth associated with : * Acute periapical abscess and/or swelling. * Greater than grade I mobility or pocket depth greater than 5mm. * Non-restorable teeth. * Immature Apex. 7. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.

Outcomes

Primary Outcomes

Incidence and severity of postoperative pain

Using an 11-point Numeric Rating Scale (NRS) where the endpoints are the extremes of no pain and worst pain. Pain intensity was assigned into one of four pain categories: none (0); Mild (1-3); Moderate (4-6) and severe (7-10). Postoperative pain levels will be documented by the patients at 6, 12, 24, 48 and 72 hours postoperatively

Time frame: From enrollment to the end of treatment at 3 days

Secondary Outcomes

Incidence and Number of analgesic intake

In case of severe or persistent postoperative pain, the operator will permit the patient to take Ibuprofen (200 mg) not more than 6 hours apart. Patients will be instructed to record their analgesic consumption by counting the number of tablets taken in the course of 72 hours postoperatively.

Time frame: From enrollment to the end of treatment at 3 days

Central Contacts

Ahmed Mahmoud Mohamed, M.S.C

CONTACT

+201032504202 ahmed-abdelrasol@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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