RetreatmentNCT06764823
Effect of Intracanal Cryotherapy on Postoperative Pain
A study testing Cryotherapy in people with Retreatment and Cryotherapy, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
Trial summary
Introduction: Since 1960, cryotherapy, involving the application of cold, has been used in various fields of medicine for pain treatment. Cold application induces three main physiological tissue responses: a decrease in metabolic activity, a reduction in blood flow, and the inhibition of neural receptors in the skin… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Retreatment, Cryotherapy
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 20 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals
- No analgesic anti-inflammatory medication intake in the last 72 hours
- Age 18-59
- PAI score of 4 (well-defined periapical radiolucency)
- Previous root canal treatment 2-4 mm short
- At least 4 years since the existing root canal treatment
- Asymptomatic acute apical periodontitis requiring retreatment of single-rooted teeth
Who cannot join
- Medically compromised patients
- Pregnant patients
- Patients taking analgesic or anti-inflammatory medication
- Patients who refuse to participate
- Patients with an allergy to articaine
- Teeth with internal and external resorption
- Teeth with open apices
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kutahya Health Sciences University Faculty of Dentistry
Kütahya
Kutahya Health Sciences University
Kütahya
About this study
Official title: Evaluation of the Effect of Intracanal Cryotherapy on Postoperative Pain After Retreatment: a Randomized Controlled Clinical Trial
Introduction: Since 1960, cryotherapy, involving the application of cold, has been used in various fields of medicine for pain treatment. Cold application induces three main physiological tissue responses: a decrease in metabolic activity, a reduction in blood flow, and the inhibition of neural receptors in the skin and subcutaneous tissues. Consequently, cryotherapy slows down neural signals and reduces the release of chemical mediators responsible for pain. Recently, the use of cryotherapy in root canal treatment, in the form of cold saline irrigation, has been investigated in several randomized controlled trials. The aim of this study is to evaluate the effect of cold saline irrigation as a final irrigant on postoperative pain following the biomechanical preparation of root canals in patients undergoing non-surgical retreatment.
Method: Sixty single-rooted, single-canal teeth requiring non-surgical root canal retreatment were randomly assigned to two groups (n = 30): a cryotherapy group and a control group. All the treatments were completed during a single visit. Protaper Universal Retreatment files (D1, D2, and D3) were used for the removal of gutta-percha and root canal preparation, and irrigation was performed using 2.5 % NaOCl and 17% EDTA. The cryotherapy group had a final irrigation temperature of 2.5 °C for 5 min before root canal obturation, whereas the control group received irrigation at room temperature.
All patients will be asked to record their postoperative pain levels on VAS scales at 6, 12, and 24 hours, and at 2, 3, and 7 days after treatment. Patients will be asked to rate the pain they experience during the 7-day postoperative period on a scale from 0 to 10. Statistical analysis was performed using the Chi-Square test, Mann-Whitney test, and Independent Samples test, with the significance level set at 0.05.
Read the detailed description
Study design
To address the aim of the research, a prospective randomized clinical trial was designed. This study will be conducted at the Department of Endodontics, Oral and Dental Health Practice and Research Center, Faculty of Dentistry, Kütahya Health Sciences University.
Patients will be informed about the study design, and all participants will be asked to read and sign the informed consent form if they agree to participate. Patient forms including demographic information, medical history, and PAI scores will be filled out. Patients who meet the inclusion criteria and agree to participate will be randomly divided into two groups: the first group will receive routine retreatment and root canal therapy followed by intracanal cryotherapy, while the second group will receive routine retreatment and root canal therapy followed by room temperature saline solution.
Root Canal Treatment Procedure The sample size for the study was calculated using the G*Power statistical program (ver.3.1.9.7). Accordingly, with a power (test strength) of 0.85, an effect size of 0.8, and a type-1 error (α) of 0.05, the minimum number of patients/samples required for each group was determined to be 30, making a total of 60 patients. Patients will undergo a single visit retreatment. Root canal treatments will be performed by a single clinician following a standard protocol. After selecting an appropriate anesthesia technique for the tooth to be treated, 1.8 mL of 4% articaine with 1:200,000 epinephrine will be injected, followed by rubber dam isolation. After opening the access cavity, the existing root canal filling will be removed using Protaper Universal Retreatment files (D1, D2, and D3) and a VDW Gold endomotor according to the manufacturer's instructions, and the working length will be established with a size 15 K-file. The working length will be confirmed with periapical radiographs. No chemical solvents will be used in the removal of the root canal filling. A size 30 H-file will be used to clean the remnants of the root canal filling. The root canal preparation will then be completed using the WaveOne Gold file system size 45.05. Between files, the canals will be irrigated with 2.5% NaOCl using a 31 gauge side-vented needle, 2 mm short of the working length.
After completing the root canal preparation, final irrigation will be performed using passive ultrasonic irrigation activation with 5 mL of 2.5% NaOCl for 1 minute, followed by 5 mL of saline and then 2 mL of 17% EDTA for 1 minute. In the cryotherapy group, after completing the biomechanical preparation, the root canals will be irrigated with 5 mL of 0.9% saline solution at 2.5°C for 5 minutes; the solution will be kept in the refrigerator until use. In the control group, the final irrigation will be performed using 5 mL of 0.9% saline solution at room temperature for 5 minutes.
The root canals will then be dried with paper points, filled with root canal sealer, and obturated using the single cone technique appropriate for the final preparation size. The access cavity will be sealed with a temporary filling, and the patient will be scheduled for a follow-up appointment in 1 week. Patients will be reminded by phone to record their pain levels at specified hours and days, and to record any analgesic consumption (including dose and time). Patients who report taking analgesics will be excluded from the study. Patients will be asked to record their postoperative pain levels on VAS scales at 6, 12, and 24 hours, and at 2, 3, and 7 days after treatment. The results will be statistically analyzed. Statistical analysis was performed using the Chi-Square test, Mann-Whitney test, and Independent Samples test, with the significance level set at 0.05.
- Conditions
- Retreatment, Cryotherapy
- Being tested
- Cryotherapy, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
In the cryotherapy group, after completing the biomechanical preparation, the root canals will be irrigated with 5 mL of 0.9% physiological saline solution at 2.5°C for 5 minutes; the solution will be stored in the refrigerator until use.
ControlOther
In the control group, the final irrigation will be performed using 5 mL of 0.9% physiological saline solution at room temperature for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | The final irrigation solution will be 5 mL of 0.9% physiological saline solution at 2.5°C, irrigated for 5 minutes. Receives: Other: Cryotherapy |
| Control | Other | The final irrigation for the control group will be 5 mL of 0.9% physiological saline solution at room temperature, irrigated for 5 minutes. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment of retreatment success
The quality of endodontic treatment will be evaluated according to the criteria established by Cleen et al.: (a) Adequate: Root canal filling 0-2 mm short of the radiographic apex. (b) Inadequate: Root canal filling more than 2 mm short of the radiographic apex. (c) Inadequate: Root canal filling extending beyond the radiographic apex.
The density of the root canal treatment will be assessed based on the criteria of Dugas et al.: (a) Adequate: Uniform radiopacity and tight adaptation of gutta-percha to the root canal walls. (b) Inadequate: Visible voids in the root canal or unfilled canals.
For the retreatment to be considered successful, it must be rated as adequate according to both of the above criteria.
Measured: "0 hours" (Treatment appointment)
Secondary outcomes (1)
Post-operative pain
Secondary endpoint is the evaluation of the effect of intracanal cryotherapy on patients' postoperative pain, assessed using the visual VAS scale included in the treatment protocol.
All patients will be asked to record their postoperative pain levels on VAS scales at 6, 12, and 24 hours, and at 2, 3, and 7 days after treatment. Patients will be asked to rate the pain they experience during the 7-day postoperative period on a scale from 0 to 10, where 0 represents no pain and 10 represents severe pain.
Measured: 6., 12., 24. hours and 2., 3. and 7. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start3 Jan 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetreatmentStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Group: The final irrigation solution will be 5 mL of 0.9% physiological saline solution at 2.5°C, irrigated for 5 minutes. Control Group: The final irrigation for the control group will be 5 mL of 0.9% physiological saline solution at room temperature, irrigated for 5 minutes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Kaya Mumcu, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764823
- Sponsor's protocol ID
- KUTAHYAHSU-2
- Status last verified
- Mar 2025
- First submitted
- 25 Dec 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Intracanal Cryotherapy on Postoperative Pain After Retreatment: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06764823
- Acronym / sponsor ID
- KUTAHYAHSU-2
- Conditions
- Retreatment, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 8 Jan 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.
Introduction: Since 1960, cryotherapy, involving the application of cold, has been used in various fields of medicine for pain treatment. Cold application induces three main physiological tissue responses: a decrease in metabolic activity, a reduction in blood flow, and the inhibition of neural receptors in the skin and subcutaneous tissues. Consequently, cryotherapy slows down neural signals and reduces the release of chemical mediators responsible for pain. Recently, the use of cryotherapy in root canal treatment, in the form of cold saline irrigation, has been investigated in several randomized controlled trials. The aim of this study is to evaluate the effect of cold saline irrigation as a final irrigant on postoperative pain following the biomechanical preparation of root canals in patients undergoing non-surgical retreatment.
Method: Sixty single-rooted, single-canal teeth requiring non-surgical root canal retreatment were randomly assigned to two groups (n = 30): a cryotherapy group and a control group. All the treatments were completed during a single visit. Protaper Universal Retreatment files (D1, D2, and D3) were used for the removal of gutta-percha and root canal preparation, and irrigation was performed using 2.5 % NaOCl and 17% EDTA. The cryotherapy group had a final irrigation temperature of 2.5 °C for 5 min before root canal obturation, whereas the control group received irrigation at room temperature.
All patients will be asked to record their postoperative pain levels on VAS scales at 6, 12, and 24 hours, and at 2, 3, and 7 days after treatment. Patients will be asked to rate the pain they experience during the 7-day postoperative period on a scale from 0 to 10. Statistical analysis was performed using the Chi-Square test, Mann-Whitney test, and Independent Samples test, with the significance level set at 0.05.
Detailed description
Study design
To address the aim of the research, a prospective randomized clinical trial was designed. This study will be conducted at the Department of Endodontics, Oral and Dental Health Practice and Research Center, Faculty of Dentistry, Kütahya Health Sciences University.
Patients will be informed about the study design, and all participants will be asked to read and sign the informed consent form if they agree to participate. Patient forms including demographic information, medical history, and PAI scores will be filled out. Patients who meet the inclusion criteria and agree to participate will be randomly divided into two groups: the first group will receive routine retreatment and root canal therapy followed by intracanal cryotherapy, while the second group will receive routine retreatment and root canal therapy followed by room temperature saline solution.
Root Canal Treatment Procedure The sample size for the study was calculated using the G*Power statistical program (ver.3.1.9.7). Accordingly, with a power (test strength) of 0.85, an effect size of 0.8, and a type-1 error (α) of 0.05, the minimum number of patients/samples required for each group was determined to be 30, making a total of 60 patients. Patients will undergo a single visit retreatment. Root canal treatments will be performed by a single clinician following a standard protocol. After selecting an appropriate anesthesia technique for the tooth to be treated, 1.8 mL of 4% articaine with 1:200,000 epinephrine will be injected, followed by rubber dam isolation. After opening the access cavity, the existing root canal filling will be removed using Protaper Universal Retreatment files (D1, D2, and D3) and a VDW Gold endomotor according to the manufacturer's instructions, and the working length will be established with a size 15 K-file. The working length will be confirmed with periapical radiographs. No chemical solvents will be used in the removal of the root canal filling. A size 30 H-file will be used to clean the remnants of the root canal filling. The root canal preparation will then be completed using the WaveOne Gold file system size 45.05. Between files, the canals will be irrigated with 2.5% NaOCl using a 31 gauge side-vented needle, 2 mm short of the working length.
After completing the root canal preparation, final irrigation will be performed using passive ultrasonic irrigation activation with 5 mL of 2.5% NaOCl for 1 minute, followed by 5 mL of saline and then 2 mL of 17% EDTA for 1 minute. In the cryotherapy group, after completing the biomechanical preparation, the root canals will be irrigated with 5 mL of 0.9% saline solution at 2.5°C for 5 minutes; the solution will be kept in the refrigerator until use. In the control group, the final irrigation will be performed using 5 mL of 0.9% saline solution at room temperature for 5 minutes.
The root canals will then be dried with paper points, filled with root canal sealer, and obturated using the single cone technique appropriate for the final preparation size. The access cavity will be sealed with a temporary filling, and the patient will be scheduled for a follow-up appointment in 1 week. Patients will be reminded by phone to record their pain levels at specified hours and days, and to record any analgesic consumption (including dose and time). Patients who report taking analgesics will be excluded from the study. Patients will be asked to record their postoperative pain levels on VAS scales at 6, 12, and 24 hours, and at 2, 3, and 7 days after treatment. The results will be statistically analyzed. Statistical analysis was performed using the Chi-Square test, Mann-Whitney test, and Independent Samples test, with the significance level set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental Group: The final irrigation solution will be 5 mL of 0.9% physiological saline solution at 2.5°C, irrigated for 5 minutes. Control Group: The final irrigation for the control group will be 5 mL of 0.9% physiological saline solution at room temperature, irrigated for 5 minutes.
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: CryotherapyThe final irrigation solution will be 5 mL of 0.9% physiological saline solution at 2.5°C, irrigated for 5 minutes. |
| Control | Other | Other: ControlThe final irrigation for the control group will be 5 mL of 0.9% physiological saline solution at room temperature, irrigated for 5 minutes. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Systemically healthy individuals
- No analgesic anti-inflammatory medication intake in the last 72 hours
- Age 18-59
- PAI score of 4 (well-defined periapical radiolucency)
- Previous root canal treatment 2-4 mm short
Key exclusion criteria (7 listed)
- Medically compromised patients
- Pregnant patients
- Patients taking analgesic or anti-inflammatory medication
- Patients who refuse to participate
- Patients with an allergy to articaine
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 |
|---|---|---|
| CryotherapyIn the cryotherapy group, after completing the biomechanical preparation, the root canals will be irrigated with 5 mL of 0.9% physiological saline solution at 2.5°C for 5 minutes; the solution will be stored in the refrigerator until use. | Other | Cryotherapy |
| ControlIn the control group, the final irrigation will be performed using 5 mL of 0.9% physiological saline solution at room temperature for 5 minutes. | Other | Control |
Primary outcome
Radiographic assessment of retreatment success
Time frame: "0 hours" (Treatment appointment)
The quality of endodontic treatment will be evaluated according to the criteria established by Cleen et al.: (a) Adequate: Root canal filling 0-2 mm short of the radiographic apex. (b) Inadequate: Root canal filling more than 2 mm short of the radiographic apex. (c) Inadequate: Root canal filling extending beyond the radiographic apex. The density of the root canal treatment will be assessed based on the criteria of Dugas et al.: (a) Adequate: Uniform radiopacity and tight adaptation of gutta-percha to the root canal walls. (b) Inadequate: Visible voids in the root canal or unfilled canals. For the retreatment to be considered successful, it must be rated as adequate according to both of the above criteria.
1 secondary outcome
Post-operative pain
Time frame: 6., 12., 24. hours and 2., 3. and 7. day
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 4 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Retreatment and Cryotherapy, run by Kutahya Health Sciences University at 2 sites 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 7 inclusion and 7 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Radiographic assessment of retreatment success (time frame: "0 hours" (Treatment appointment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2025.