Pulpitis - IrreversibleNCT06820996
Effect of Cryotreated Sodium Hypochlorite Irrigation at Different Consentrations in Mandibular First Molars
A study testing Cryotherapy in people with Pulpitis - Irreversible, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to evaluate the effect of cryotreated sodium hypochlorite solution on the intensity of postoperative pain in root canal treatment procedures in mandibular first molar teeth with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Devital teeth that responded negatively to cold tests and electric pulp tests,
- Teeth with poor periodontal status (pocket depth > 4 mm),
- Mandibular first molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity,
- Teeth with no preoperative pain or with mild preoperative pain (VAS value below 4) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cryotreated Sodium Hypochlorite Irrigation at Different Consentrations in Mandibular First Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
The goal of this clinical trial was to evaluate the effect of cryotreated sodium hypochlorite solution on the intensity of postoperative pain in root canal treatment procedures in mandibular first molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:
- Does controlled irrigation with cold sodium hypochlorite in root canal treatment reduce the severity of postoperative pain? In the cryotreated NaOCl group, unlike the normal NaOCl group, the root canals were irrigated with 2 °C NaOCl solution.
Read the detailed description
Various irrigation solutions that are effective for organic and inorganic tissues are used during root canal treatment. Sodium hypochlorite (NaOCl) is the most commonly used irrigation solution. It has antibacterial and physicochemical properties 20 and is unique in dissolving organic tissues 21. NaOCl irrigation combined with mechanical instrumentation has been consistently shown to substantially reduce the microorganism load in root canals 22. There have been several attempts to increase the antimicrobial efficacy of NaOCl in the root canal system, such as changing its concentration, increasing the contact time with the dentin walls of the root canal, increasing the total volume of irrigation, increasing its temperature, and using manual or mechanical activation methods 3, 23. These methods to increase the efficacy of NaOCl can also result in heightened toxic effects on periapical tissues owing to the tissue-irritating properties of the solution. This extrusion into the periapical region increases postoperative pain, especially in teeth with open apices and necrotic pulps 21, 24. Therefore, instead of using high concentrations of NaOCl, which could increase its toxic effects, safer means, such as increasing its temperature and using it in large volumes, may increase its efficacy 21, 25.
Therefore, ascertaining the clinical impact of cryotreated NaOCl on postoperative pain is essential. The temperature of the irrigation solution is known to affect postoperative pain, and final irrigation with cold saline significantly reduces postoperative pain levels 19, 26. However, studies investigating the effects of cryotreated NaOCl, which is used in all stages of root canal treatment, and using NaOCl at concentrations of 2.5% and 5% on postoperative pain are lacking. This randomized clinical trial investigated the effects of cryotreated 2.5% and 5% NaOCl on postoperative pain during endodontic treatment procedures in mandibular first molars with symptomatic irreversible pulpitis.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Cryotherapy, Control (Standard treatment)
- Keywords
- Cryotherapy, Irreversible pulpits, Sodium hypochlorite, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Also called Normal
The root canals were irrigated with 2 °C NaOCl solution in cryotherapy group.
Control (Standard treatment)Other
The root canals were irrigated with 25 °C NaOCl solution in normal group.
| Study group | Role | What they receive |
|---|---|---|
| Cryotreated %2.5 NaOCl | Experimental | A total of 45 ml of 2.5% NaOCl cooled to 2 °C in the refrigerator was placed in 2.5 ml syringes. The syringes were placed in a cold storage box to maintain the temperature during use. The box was filled with ice and the temperature was verified at 2 °C with a digital thermometer. During the root canal preparation, each canal was irrigated with a total of 10 ml of 2.5% NaOCl at 2 °C. The procedure was completed by using 5 ml of 2.5% NaOCl at 2.5 °C, 2 ml of saline, 2 mL of 17% EDTA and 2 ml of saline for each root canal, respectively, as the final irrigation solution. Receives: Other: Cryotherapy |
| Normal %2.5 NaOCl | Experimental | 45 milliliters (ml) of 2.5% NaOCl was placed in a glass container at room temperature and the temperature was monitored with a digital thermometer to ensure that it remained at 25 °C. During root canal preparation, each canal was irrigated with a total of 10 ml of 25 °C 2.5% NaOCl. The procedure was completed by using 5 ml of 25 °C 2.5% NaOCl, 2 ml of saline, 2 ml of 17% EDTA and 2 ml of saline for each root canal, respectively, as the final irrigation solution. Receives: Other: Control (Standard treatment) |
| Cryotreated %5 NaOCl | Experimental | A total of 45 ml of 5% NaOCl cooled to 2 °C in the refrigerator was placed in 2.5 ml syringes. The syringes were placed in a cold storage box to maintain the temperature during use. The box was filled with ice and the temperature was verified at 2 °C with a digital thermometer. During the root canal preparation, each canal was irrigated with a total of 10 ml of 5% NaOCl at 2 °C. As the final irrigation solution, 5 ml of 5% NaOCl at 2 °C, 2 ml of saline, 2 mL of 17% EDTA and 2 ml of saline were used for each root canal, respectively, to complete the procedure. Receives: Other: Cryotherapy |
| Normal %5 NaOCl | Experimental | 45 ml of 5% NaOCl was placed in a glass container at room temperature and the temperature was monitored with a digital thermometer to ensure that it remained at 25 °C. During the root canal preparation, each canal was irrigated with a total of 10 ml of 25 °C 5% NaOCl. As the final irrigation solution, 5 ml of 25 °C 5% NaOCl, 2 ml of saline, 2 ml of 17% EDTA and 2 ml of saline were used for each root canal, respectively, and the procedure was completed. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start18 Mar 2024
- Primary completion18 Nov 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
- Investigators
- Koray Yılmaz, DDS MSc, Principal investigator, Cukurova Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820996
- Sponsor's protocol ID
- 13.02.2025/150
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 33384483Lalfakawmi 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 38987018Gurler K, Yilmaz K. The effect of cryotreated sodium hypochlorite irrigation at different concentrations on postoperative pain in mandibular first molars with symptomatic irreversible pulpitis: a randomized controlled clinical trial. BMC Oral Health. 2025 Nov 25;25(1):1983. doi: 10.1186/s12903-025-07410-3.
PubMed 41291644
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryotreated Sodium Hypochlorite Irrigation at Different Consentrations in Mandibular First Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06820996
- Acronym / sponsor ID
- 13.02.2025/150
- Conditions
- Pulpitis - Irreversible
- Keywords
- Cryotherapy, Irreversible pulpits, Sodium hypochlorite, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 11 Feb 2025 (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 goal of this clinical trial was to evaluate the effect of cryotreated sodium hypochlorite solution on the intensity of postoperative pain in root canal treatment procedures in mandibular first molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:
- Does controlled irrigation with cold sodium hypochlorite in root canal treatment reduce the severity of postoperative pain? In the cryotreated NaOCl group, unlike the normal NaOCl group, the root canals were irrigated with 2 °C NaOCl solution.
Detailed description
Various irrigation solutions that are effective for organic and inorganic tissues are used during root canal treatment. Sodium hypochlorite (NaOCl) is the most commonly used irrigation solution. It has antibacterial and physicochemical properties 20 and is unique in dissolving organic tissues 21. NaOCl irrigation combined with mechanical instrumentation has been consistently shown to substantially reduce the microorganism load in root canals 22. There have been several attempts to increase the antimicrobial efficacy of NaOCl in the root canal system, such as changing its concentration, increasing the contact time with the dentin walls of the root canal, increasing the total volume of irrigation, increasing its temperature, and using manual or mechanical activation methods 3, 23. These methods to increase the efficacy of NaOCl can also result in heightened toxic effects on periapical tissues owing to the tissue-irritating properties of the solution. This extrusion into the periapical region increases postoperative pain, especially in teeth with open apices and necrotic pulps 21, 24. Therefore, instead of using high concentrations of NaOCl, which could increase its toxic effects, safer means, such as increasing its temperature and using it in large volumes, may increase its efficacy 21, 25.
Therefore, ascertaining the clinical impact of cryotreated NaOCl on postoperative pain is essential. The temperature of the irrigation solution is known to affect postoperative pain, and final irrigation with cold saline significantly reduces postoperative pain levels 19, 26. However, studies investigating the effects of cryotreated NaOCl, which is used in all stages of root canal treatment, and using NaOCl at concentrations of 2.5% and 5% on postoperative pain are lacking. This randomized clinical trial investigated the effects of cryotreated 2.5% and 5% NaOCl on postoperative pain during endodontic treatment procedures in mandibular first molars with symptomatic irreversible pulpitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cryotreated %2.5 NaOCl | Experimental | Other: CryotherapyA total of 45 ml of 2.5% NaOCl cooled to 2 °C in the refrigerator was placed in 2.5 ml syringes. The syringes were placed in a cold storage box to maintain the temperature during use. The box was filled with ice and the temperature was verified at 2 °C with a digital thermometer. During the root canal preparation, each canal was irrigated with a total of 10 ml of 2.5% NaOCl at 2 °C. The procedure was completed by using 5 ml of 2.5% NaOCl at 2.5 °C, 2 ml of saline, 2 mL of 17% EDTA and 2 ml of saline for each root canal, respectively, as the final irrigation solution. |
| Normal %2.5 NaOCl | Experimental | Other: Control (Standard treatment)45 milliliters (ml) of 2.5% NaOCl was placed in a glass container at room temperature and the temperature was monitored with a digital thermometer to ensure that it remained at 25 °C. During root canal preparation, each canal was irrigated with a total of 10 ml of 25 °C 2.5% NaOCl. The procedure was completed by using 5 ml of 25 °C 2.5% NaOCl, 2 ml of saline, 2 ml of 17% EDTA and 2 ml of saline for each root canal, respectively, as the final irrigation solution. |
| Cryotreated %5 NaOCl | Experimental | Other: CryotherapyA total of 45 ml of 5% NaOCl cooled to 2 °C in the refrigerator was placed in 2.5 ml syringes. The syringes were placed in a cold storage box to maintain the temperature during use. The box was filled with ice and the temperature was verified at 2 °C with a digital thermometer. During the root canal preparation, each canal was irrigated with a total of 10 ml of 5% NaOCl at 2 °C. As the final irrigation solution, 5 ml of 5% NaOCl at 2 °C, 2 ml of saline, 2 mL of 17% EDTA and 2 ml of saline were used for each root canal, respectively, to complete the procedure. |
| Normal %5 NaOCl | Experimental | Other: Control (Standard treatment)45 ml of 5% NaOCl was placed in a glass container at room temperature and the temperature was monitored with a digital thermometer to ensure that it remained at 25 °C. During the root canal preparation, each canal was irrigated with a total of 10 ml of 25 °C 5% NaOCl. As the final irrigation solution, 5 ml of 25 °C 5% NaOCl, 2 ml of saline, 2 ml of 17% EDTA and 2 ml of saline were used for each root canal, respectively, and the procedure was completed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Devital teeth that responded negatively to cold tests and electric pulp tests,
- Teeth with poor periodontal status (pocket depth > 4 mm),
- Mandibular first molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity,
- Teeth with no preoperative pain or with mild preoperative pain (VAS value below 4) were excluded from the study.
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 |
|---|---|---|
| CryotherapyAlso: NormalThe root canals were irrigated with 2 °C NaOCl solution in cryotherapy group. | Other | Cryotreated %2.5 NaOCl, Cryotreated %5 NaOCl |
| Control (Standard treatment)The root canals were irrigated with 25 °C NaOCl solution in normal group. | Other | Normal %2.5 NaOCl, Normal %5 NaOCl |
Primary outcome
Visual Analogue Scale
Time frame: up to 72 hours
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Results publication: 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.
- Results publication: 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.
- Derived from this study: PubMed 41291644Gurler K, Yilmaz K. The effect of cryotreated sodium hypochlorite irrigation at different concentrations on postoperative pain in mandibular first molars with symptomatic irreversible pulpitis: a randomized controlled clinical trial. BMC Oral Health. 2025 Nov 25;25(1):1983. doi: 10.1186/s12903-025-07410-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Koray Yılmaz, DDS MSc principal investigator
Cukurova Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Pulpitis - Irreversible, run by Cukurova University at 1 site in Turkey (Türkiye).
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 0 inclusion and 4 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: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: up to 72 hours). 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 NCT06820996, which also lists 3 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 14 Feb 2025.