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NCT Number: NCT07676409

Effect of Two Different Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain

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.

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Key information

Conditions

Cryotherapy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 20-40 years old.
  • Systemically healthy patients (ASA I or II).
  • 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.
  • Restorable teeth.
  • Ability to complete the endodontic treatment in a single visit.
  • Positive patient acceptance for participation in the trial. -----------------------------------------------------------------

Exclusion criteria

  • 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.
  • Patients reporting bruxism or clenching.
  • 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.
  • Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.

Treatment and study plan

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.

Primary outcomes

  1. Incidence and severity of postoperative pain

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

    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

Secondary outcomes

  1. Incidence and Number of analgesic intake

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mahmoud Mohamed, M.S.C

CONTACT

[email protected]

+201032504202

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Two Intracanal Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis and Apical Periodontitis in Mandibular Molars: A Randomized Clinical Trial.

Acronym: NAOCL/EDTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 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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