Effect of Two Different Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain

ConditionCryotherapy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-40

SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 20-40 years old.

Systemically healthy patients (ASA I or II).

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).

Disqualifiers

Medically compromised patients (ASA III or IV)

Patients who used NSAIDs in the 24 hours before treatment.

Patients with two or more adjacent teeth requiring endodontic treatment.

Pregnant women.

Trial design

Design model

Parallel

Treatments tested in this trial

Full Cryotherapy Irrigation (FC)
Procedure/Surgery
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/Surgery
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/Surgery
Full intracanal irrigation performed at room-temperature using 2.5% sodium hypochlorite solution, followed by saline, EDTA, and a final rinse with saline.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Control ArmActive comparator 1 intervention

Group B: Experimental Arm AExperimental treatment 1 intervention

Group C: Experimental Arm BExperimental treatment 1 intervention

Trial 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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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