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Not yet recruiting NCT07676409

Effect of Two Different Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain

No phase Interventional Cryotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Full Cryotherapy Irrigation (FC), Final Flush Cryotherapy Irrigation (FFC), Conventional Irrigation (CI).
Who it may be relevant to
Registry conditions: Cryotherapy. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

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.

Interventions

  • Procedure Full Cryotherapy Irrigation (FC)
    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
  • Procedure Final Flush Cryotherapy Irrigation (FFC)
    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).
  • Procedure Conventional Irrigation (CI)
    Full intracanal irrigation performed at room-temperature using 2.5% sodium hypochlorite solution, followed by saline, EDTA, and a final rinse with saline.

Primary outcome measures

  • Incidence and severity of postoperative pain [Time frame: From enrollment to the end of treatment at 3 days]
Secondary outcome measures (1)
  • Incidence and Number of analgesic intake [Time frame: From enrollment to the end of treatment at 3 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Vera J, Ochoa-Rivera J, Vazquez-Carcano M, Romero M, Arias A, Sleiman P. Effect of Intracanal Cryotherapy on Reducing Root Surface Temperature. J Endod. 2015 Nov;41(11):1884-7. doi: 10.1016/j.joen.2015.08.009. Epub 2015 Oct 1. PMID 26433855
  • Siqueira JF, Barnett F (2004) Interappointment pain: mechanisms, diagnosis, and treatment. Endod Topics 7:93-109. https://doi.org/10.1111/J.1601-1546.2004.00062.X
  • Sharaf RMA, Abdelrahman TY, Obeid MF. The impact of using cold irrigation on postoperative endodontic pain and substance P level: a randomized clinical trial. Odontology. 2026 Apr;114(2):527-536. doi: 10.1007/s10266-025-01131-3. Epub 2025 Jun 18. PMID 40533695
  • Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23. PMID 17956561
  • Rosenberg PA (2002) Clinical strategies for managing endodontic pain. Endod Topics 3:78-92. https://doi.org/10.1034/J.1601-1546.2002.30108.X
  • Patel NK, Doshi P, Dalal SR, et al (2025) Impact of intracanal cryotherapy on postoperative pain in symptomatic apical periodontitis: A systematic review and meta-analysis of randomized clinical trials. Endodontology 37:101-109. https://doi.org/10.4103/ENDO.ENDO_318_24
  • Nandakumar M, Nasim I. Effect of intracanal cryotreated sodium hypochlorite on postoperative pain after root canal treatment - A randomized controlled clinical trial. J Conserv Dent. 2020 Mar-Apr;23(2):131-136. doi: 10.4103/JCD.JCD_65_20. Epub 2020 Nov 5. PMID 33384483
  • Magy Essam Elaskary., et al. "Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth with Symptomatic Irreversible Pulpitis and Apical Periodontitis: A Randomized Clinical Trial". Acta Scientific Dental Sciences 5.2 (2021): 143-149.

Identifiers

NCT: NCT07676409 · cryotherapy in endodontic pain

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗