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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 3 days |
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Inclusion Criteria:
Age between 20-40 years old.
Systemically healthy patients (ASA I or II).
Mature Mandibular molar teeth with :
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 :
Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Mahmoud Mohamed, M.S.C | Contact | +201032504202 | ahmed-abdelrasol@dentistry.cu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26433855 | Background | 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. | |
| 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 | ||
| 40533695 |
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| 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. |
|
| 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. |
| 17956561 | 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. |
| 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 |
| 33384483 | 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. |
| 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. |
| 25526231 | 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. |
| 37770960 | 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. |
| 38987018 | 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. |
| 27699913 | 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. |
| 20478449 | 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. |
| 29398090 | 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. |
| 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. |
| 40297278 | 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. |