Pulpitis - IrreversibleNCT07233577
Adjunctive Irrigation Strategies for Postoperative Pain After Full Pulpotomy
A study testing Cryotherapy and Dexametasone in people with Pulpitis - Irreversible, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effects of cryotherapy and dexamethasone on the intensity of postoperative pain in full pulpotomy procedures in permanent molars 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 Dexametasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2024to 16 Jun 2025
- Phase
- Interventional
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 permanent molars exhibiting positive responses to both the cold test and the electric pulp test, with a prolonged cold response (>30 seconds) consistent with symptomatic irreversible pulpitis.
- Presence of deep carious lesions in the included teeth (indicated for vital pulp therapy).
- No radiographic evidence of periapical pathology (i.e., no periapical radiolucency, root resorption, or pathological widening of the periodontal ligament space).
- Patients who had not taken analgesics or antibiotics during the 24 hours preceding the procedure.
Who cannot join
- Devital permanent molars that responded negatively to cold tests and electric pulp tests
- Permanent molars with poor periodontal status (pocket depth > 4 mm),
- Teeth that exhibited periapical radiolucency, pathological mobility, or were deemed non-restorable
- Systemic diseases, pregnancy or lactation, known allergies to dexamethasone or NSAIDs, recent use of analgesics (within 24 hours), and any contraindications for pulpotomy or local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Irrigation Strategies for Pain Control After Full Pulpotomy in Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate the effects of cryotherapy and dexamethasone on the intensity of postoperative pain in full pulpotomy procedures in permanent molars with symptomatic irreversible pulpitis. The main questions it aims to answer are:
- Does controlled irrigation with cold saline during full pulpotomy reduce the severity of postoperative pain?
- Does controlled irrigation with dexamethasone during full pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone groups, the pulp chamber was irrigated with 2°C saline solution during the final irrigation step.
In the dexamethasone group, unlike the control and cryotherapy groups, the pulp chamber was irrigated with 2 mL dexamethasone solution during the final irrigation step.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Cryotherapy, Dexametasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
In the cryotherapy group, the pulp chamber was irrigated with 5 mL of sterile saline solution pre-cooled to 2.5°C during full pulpotomy.
DexametasoneDrug
In the dexamethasone group, the pulp chamber was irrigated with 2 mL of dexamethasone sodium phosphate solution (4 mg/mL) during full pulpotomy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The pulp chamber was irrigated with 5 mL of sterile saline at room temperature (22-25°C). The solution was delivered slowly into the pulp chamber using a sterile syringe with a blunt needle tip and left in place for 5 minutes to allow direct contact with the exposed radicular pulp tissue. Afterward, the chamber was dried gently with sterile cotton pellets. |
| Cryotherapy Group | Experimental | 5 mL of sterile saline solution pre-cooled to 2.5°C was administered into the pulp chamber using the same technique. This solution was also left in contact with the pulp tissue for 5 minutes, without aspiration, to provide localized cold exposure. The cold saline was stored in a calibrated medical cooler and monitored with a digital thermometer to ensure consistent temperature throughout the clinical procedure. Receives: Other: Cryotherapy |
| Dexamethasone Group | Experimental | The pulp chamber was irrigated with 2 mL of a dexamethasone sodium phosphate solution at a concentration of 4 mg/mL (Decort®, DEVA Holding, Türkiye). The solution was slowly delivered into the pulp chamber using a sterile syringe with a blunt-tipped needle and left in place for 1 minute to allow direct contact with the exposed radicular pulp tissue. Subsequently, the chamber was gently dried with sterile cotton pellets. Receives: Drug: Dexametasone |
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 Nov 2025
- Study start18 Dec 2024
- Primary completion5 May 2025
- Study completion16 Jun 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.
- 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
- 72 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, Professor, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233577
- Sponsor's protocol ID
- 06.12.2024/15
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dildar 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 38576278Solomon 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 38600937Rogers 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 10530266