Effect of Two Different Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain

NCT07676409 | Not Yet Recruiting

• 1 other identifier: cryotherapy in endodontic pain
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cryotherapy

Keywords

Cryotherapy; Postoperative endodontic pain; irrigation

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of treatment at 3 days

Secondary Outcomes (1)

• Incidence and Number of analgesic intake

  From enrollment to the end of treatment at 3 days

Study Arms (3)

Control Arm

ACTIVE COMPARATOR

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

Procedure: Conventional Irrigation (CI)

Experimental Arm A

EXPERIMENTAL

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 (2-3°C).

Procedure: Full Cryotherapy Irrigation (FC)

Experimental Arm B

EXPERIMENTAL

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: Final Flush Cryotherapy Irrigation (FFC)

Interventions

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).

Experimental Arm B

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

Experimental Arm A

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.

Control Arm

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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. -----------------------------------------------------------------

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (16)

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for musculoskeletal injury. Postgrad Med. 2015 Jan;127(1):57-65. doi: 10.1080/00325481.2015.992719. Epub 2014 Dec 15.

  PMID: 25526231 BACKGROUND

• Legrand FD, Dugue B, Costello J, Bleakley C, Miller E, Broatch JR, Polidori G, Lubkowska A, Louis J, Lombardi G, Bieuzen F, Capodaglio P. Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium. Eur J Med Res. 2023 Sep 28;28(1):387. doi: 10.1186/s40001-023-01385-z.

  PMID: 37770960 BACKGROUND

• Lalfakawmi S, Gupta A, Duraisamy AK, Abraham D, Mrinalini M, Mane AP. Impact of Cryotreated and Warm Sodium Hypochlorite on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial. J Endod. 2024 Nov;50(11):1543-1550. doi: 10.1016/j.joen.2024.07.002. Epub 2024 Jul 8.

  PMID: 38987018 BACKGROUND

• Keskin C, Ozdemir O, Uzun I, Guler B. Effect of intracanal cryotherapy on pain after single-visit root canal treatment. Aust Endod J. 2017 Aug;43(2):83-88. doi: 10.1111/aej.12175. Epub 2016 Oct 4.

  PMID: 27699913 BACKGROUND

• Jalalzadeh SM, Mamavi A, Shahriari S, Santos FA, Pochapski MT. Effect of pretreatment prednisolone on postendodontic pain: a double-blind parallel-randomized clinical trial. J Endod. 2010 Jun;36(6):978-81. doi: 10.1016/j.joen.2010.03.015. Epub 2010 Apr 24.

  PMID: 20478449 BACKGROUND

• Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.

  PMID: 29398090 BACKGROUND

• Bazaid DS, Kenawi LMM (2018) The effect of intracanal cryotherapy in reducing postoperative pain in patients with irreversible pulpitis: a randomized control trial. Int J Health Sci Res 8(2):83-88.

  BACKGROUND

• Ahmad MZ. Effects of intracanal cryotherapy on postoperative pain in necrotic teeth with symptomatic apical periodontitis: a randomized controlled clinical trial. Front Dent Med. 2025 Apr 14;6:1543383. doi: 10.3389/fdmed.2025.1543383. eCollection 2025.

  PMID: 40297278 BACKGROUND

Central Study Contacts

Ahmed Mahmoud Mohamed, M.S.C

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06