CryotherapyNAOCL/EDTANCT07676409
Effect of Two Different Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain
A study testing Full Cryotherapy Irrigation (FC), Final Flush Cryotherapy Irrigation (FFC) and Conventional Irrigation (CI) in people with Cryotherapy, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Cryotherapy
- What is being tested?
- Full Cryotherapy Irrigation (FC), Final Flush Cryotherapy Irrigation (FFC) and Conventional Irrigation (CI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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. -----------------------------------------------------------------
Who cannot join
- 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 :
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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
- Being tested
- Full Cryotherapy Irrigation (FC), Final Flush Cryotherapy Irrigation (FFC), Conventional Irrigation (CI)
- Keywords
- Cryotherapy, Postoperative endodontic pain, irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Cryotherapy Irrigation (FC)Procedure or 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 or 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 or surgery
Full intracanal irrigation performed at room-temperature using 2.5% sodium hypochlorite solution, followed by saline, EDTA, and a final rinse with saline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: Procedure: Final Flush Cryotherapy Irrigation (FFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 3 days
Secondary outcomes (1)
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.
Measured: From enrollment to the end of treatment at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for CryotherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676409
- Sponsor's protocol ID
- cryotherapy in endodontic pain
- Acronym
- NAOCL/EDTA
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26433855Siqueira 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.
PubMed 40533695Sathorn 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.
PubMed 17956561Rosenberg 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.
PubMed 33384483Magy 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.
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.
PubMed 25526231Legrand 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.
PubMed 37770960Lalfakawmi 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.
PubMed 38987018Keskin 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.
PubMed 27699913Jalalzadeh 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.
PubMed 20478449Gundogdu 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.
PubMed 29398090Bazaid 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07676409
- Acronym / sponsor ID
- NAOCL/EDTA / cryotherapy in endodontic pain
- Conditions
- Cryotherapy
- Keywords
- Cryotherapy, Postoperative endodontic pain, irrigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | 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. |
| Experimental Arm A | Experimental | 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 (2-3°C). |
| Experimental Arm B | Experimental | 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). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Experimental Arm A |
| 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 or surgery | Experimental Arm B |
| 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. | Procedure or surgery | Control Arm |
Primary outcome
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
1 secondary outcome
Incidence and Number of analgesic intake
Time frame: From enrollment to the end of treatment at 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 26433855Vera 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.
- BackgroundSiqueira 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: PubMed 40533695Sharaf 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.
- Background: PubMed 17956561Sathorn 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.
- BackgroundRosenberg PA (2002) Clinical strategies for managing endodontic pain. Endod Topics 3:78-92. https://doi.org/10.1034/J.1601-1546.2002.30108.X
- BackgroundPatel 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: PubMed 33384483Nandakumar 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.
- BackgroundMagy 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: PubMed 25526231Malanga 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.
- Background: PubMed 37770960Legrand 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.
- Background: PubMed 38987018Lalfakawmi 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.
- Background: PubMed 27699913Keskin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Full Cryotherapy Irrigation (FC), Final Flush Cryotherapy Irrigation (FFC) and Conventional Irrigation (CI) in people with Cryotherapy, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mahmoud Mohamed, M.S.C (+201032504202, ahmed-abdelrasol@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of postoperative pain (time frame: From enrollment to the end of treatment at 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07676409, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.