Pulpitis - IrreversibleNCT06832254
Cryotherapy Versus Dexamethasone on Postoperative Pain in Permanent Mandibular Molars
A study testing Cryotherapy and Dexamethasone 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 cryotherapy versus dexamethasone 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 and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2024to 5 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
- Vital mandibular first and second molars with 3 root canals that responded positively to the cold test and electric pulp test
- Patients who had not taken analgesics or antibiotics in the last 24 hours before the procedure were included in the study.
Who cannot join
- Devital mandibular first and second molars that responded negatively to cold tests and electric pulp tests
- Mandibular first and second molars with poor periodontal status (pocket depth > 4 mm),
- Mandibular first and second molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cryotherapy Versus Dexamethasone on Reducing Postoperative Pain in Permanent Mandibular Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
The goal of this clinical trial was to evaluate cryotherapy versus dexamethasone 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 saline in root canal treatment reduce the severity of postoperative pain?
- Does controlled irrigation with dexamethasone in root canal treatment reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone group, the root canals were irrigated with 2 °C salin solution in final irrigation.
In the dexamethasone group, unlike the control and cryotherapy group, the root canals were irrigated with 1 mL dexamethasone solution in final irrigation.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Cryotherapy, Dexamethasone
- Keywords
- Cryotherapy, Irrevesible pulpitis, Dexamethasone, 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
The root canals were irrigated with 2 °C saline solution in final irrigation in cryotherapy group.
DexamethasoneDrug
Each root canal was irrigated with 1 mL dexamethasone solution in final irrigation in dexamethasone group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of normal saline for 5 minutes. |
| Cryotherapy Group | Experimental | Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of cold (2 °C) saline for 5 minutes. Receives: Other: Cryotherapy |
| Dexamethasone Group | Experimental | Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA, 2 mL saline and 1 mL dexamethasone. Receives: Drug: Dexamethasone |
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 posted18 Feb 2025
- Study start5 Apr 2024
- Primary completion10 Dec 2024
- Study completion5 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
- 60 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832254
- Sponsor's protocol ID
- 13.02.2025/151
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogers MJ, Johnson BR, Remeikis NA, BeGole EA. Comparison of effect of intracanal use of ketorolac tromethamine and dexamethasone with oral ibuprofen on post treatment endodontic pain. J Endod. 1999 May;25(5):381-4. doi: 10.1016/S0099-2399(06)81176-3.
PubMed 10530266Solomon RV, Paneeru SP, Swetha C, Yatham R. Comparative evaluation of effect of intracanal cryotherapy and corticosteroid solution on post endodontic pain in single visit root canal treatment. J Clin Exp Dent. 2024 Mar 1;16(3):e250-e256. doi: 10.4317/jced.61023. eCollection 2024 Mar.
PubMed 38600937Dildar I, Moghal A, Mirza A, Zaheer MA, Mallick MR, Munir S. Evaluation of Postoperative Pain after Using Dexamethasone Intracanal Rinse in Irreversible Pulpitis. J Coll Physicians Surg Pak. 2024 Apr;34(4):390-393. doi: 10.29271/jcpsp.2024.04.390.
PubMed 38576278
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cryotherapy Versus Dexamethasone on Reducing Postoperative Pain in Permanent Mandibular Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06832254
- Acronym / sponsor ID
- 13.02.2025/151
- Conditions
- Pulpitis - Irreversible
- Keywords
- Cryotherapy, Irrevesible pulpitis, Dexamethasone, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 18 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 cryotherapy versus dexamethasone 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 saline in root canal treatment reduce the severity of postoperative pain?
- Does controlled irrigation with dexamethasone in root canal treatment reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone group, the root canals were irrigated with 2 °C salin solution in final irrigation.
In the dexamethasone group, unlike the control and cryotherapy group, the root canals were irrigated with 1 mL dexamethasone solution in final irrigation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of normal saline for 5 minutes. |
| Cryotherapy Group | Experimental | Other: CryotherapyIrrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of cold (2 °C) saline for 5 minutes. |
| Dexamethasone Group | Experimental | Drug: DexamethasoneIrrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA, 2 mL saline and 1 mL dexamethasone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vital mandibular first and second molars with 3 root canals that responded positively to the cold test and electric pulp test
- Patients who had not taken analgesics or antibiotics in the last 24 hours before the procedure were included in the study.
Key exclusion criteria (3 listed)
- Devital mandibular first and second molars that responded negatively to cold tests and electric pulp tests
- Mandibular first and second molars with poor periodontal status (pocket depth > 4 mm),
- Mandibular first and second molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity 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 |
|---|---|---|
| CryotherapyThe root canals were irrigated with 2 °C saline solution in final irrigation in cryotherapy group. | Other | Cryotherapy Group |
| DexamethasoneEach root canal was irrigated with 1 mL dexamethasone solution in final irrigation in dexamethasone group. | Drug | Dexamethasone Group |
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 11 Mar 2025.
- Background: PubMed 10530266Rogers MJ, Johnson BR, Remeikis NA, BeGole EA. Comparison of effect of intracanal use of ketorolac tromethamine and dexamethasone with oral ibuprofen on post treatment endodontic pain. J Endod. 1999 May;25(5):381-4. doi: 10.1016/S0099-2399(06)81176-3.
- Background: PubMed 38600937Solomon RV, Paneeru SP, Swetha C, Yatham R. Comparative evaluation of effect of intracanal cryotherapy and corticosteroid solution on post endodontic pain in single visit root canal treatment. J Clin Exp Dent. 2024 Mar 1;16(3):e250-e256. doi: 10.4317/jced.61023. eCollection 2024 Mar.
- Background: PubMed 38576278Dildar I, Moghal A, Mirza A, Zaheer MA, Mallick MR, Munir S. Evaluation of Postoperative Pain after Using Dexamethasone Intracanal Rinse in Irreversible Pulpitis. J Coll Physicians Surg Pak. 2024 Apr;34(4):390-393. doi: 10.29271/jcpsp.2024.04.390.
- 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 University
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 and Dexamethasone 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 2 inclusion and 3 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 11 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 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 NCT06832254, 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 11 Mar 2025.