Irreversible PulpitisNCT07403578
Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis
A study testing infiltration anesthesia alone, mandibular anesthesia alone and infiltration anesthesia combined with cryotherapy in people with Irreversible Pulpitis and Cryotherapy, run by TC Erciyes University.
Trial summary
This prospective randomized clinical trial aimed to evaluate the effects of different anesthesia protocols on anesthetic success and intraoperative pain during root canal treatment of mandibular premolars diagnosed with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Cryotherapy
- What is being tested?
- infiltration anesthesia alone, mandibular anesthesia alone and infiltration anesthesia combined with cryotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 30 Dec 2026
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients classified as ASA I or II, aged between 18 and 60 years,
- Presence of a restorable mandibular premolar tooth diagnosed with symptomatic irreversible pulpitis,
- History of spontaneous pain or lingering pain elicited by thermal stimuli,
- Positive response with lingering pain to cold testing (Endo Ice; Coltene, Altstätten, Switzerland),
- Positive response at low current levels to electric pulp testing (Parkell Inc., USA),
- Teeth with closed apex and no radiographic evidence of periapical pathology (intact periodontal ligament space and absence of periapical radiolucency),
- Patients presenting with moderate or severe preoperative pain, as assessed using the visual analogue scale (VAS).
Who cannot join
- Patients who had taken analgesic, anti-inflammatory, or opioid medication within the last 12 hours before treatment,
- Patients with systemic conditions that may affect pain perception, inflammatory response, or healing,
- History of antibiotic use within the previous month or requirement for antibiotic prophylaxis,
- Teeth presenting with clinical or radiographic signs of pulp necrosis or apical periodontitis (Pain on percussion or palpation, presence of sinus tract or swelling, presence of periapical radiolucency),
- Teeth with root resorption, immature apices, severe coronal destruction preventing proper isolation, or calcified canals,
- Teeth that had undergone previous endodontic treatment, including pulpotomy or root canal filling,
- Patients with neurological or psychiatric conditions that could interfere with pain perception or accurate pain reporting,
- Inability to achieve adequate isolation with a rubberdam.
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 Cryotherapy On Anesthetıc Success And Intraoperatıve Paın In Mandıbular Premolars Wıth Irreversıble Pulpıtıs: A Prospectıve Randomızed Clınıcal Trıal
This prospective randomized clinical trial aimed to evaluate the effects of different anesthesia protocols on anesthetic success and intraoperative pain during root canal treatment of mandibular premolars diagnosed with symptomatic irreversible pulpitis. A total of 100 systemically healthy patients were randomly allocated into four groups: infiltration anesthesia alone, inferior alveolar nerve block (IANB) alone, infiltration anesthesia combined with cryotherapy, and IANB combined with cryotherapy. Cryotherapy was applied intraorally for 5 minutes immediately after anesthetic administration.
The effectiveness of anesthesia was confirmed using electric pulp testing and cold testing prior to treatment. Root canal therapy was completed in a single visit by a calibrated operator. Intraoperative pain was assessed during access cavity preparation using a visual analogue scale (VAS). Anesthetic success was defined as the presence of no or mild pain, whereas moderate or severe pain indicated anesthetic failure and required supplemental anesthesia.
The primary objective of the study was to determine whether the adjunctive use of cryotherapy improves anesthetic success and reduces intraoperative pain in mandibular premolars with symptomatic irreversible pulpitis. The null hypothesis was that no significant differences would be observed among the study groups in terms of anesthetic success or intraoperative pain intensity.
- Conditions
- Irreversible Pulpitis, Cryotherapy
- Being tested
- infiltration anesthesia alone, mandibular anesthesia alone, infiltration anesthesia combined with cryotherapy, mandibular anesthesia combined with cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infiltration anesthesia aloneProcedure or surgery
Local anesthesia was achieved using buccal infiltration with 2% lidocaine and 1:100,000 epinephrine.
mandibular anesthesia aloneProcedure or surgery
Local anesthesia was achieved using mandibular block anesthesia with 2% lidocaine and 1:100,000 epinephrine.
infiltration anesthesia combined with cryotherapyProcedure or surgery
Cryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication
mandibular anesthesia combined with cryotherapyProcedure or surgery
Cryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication
| Study group | Role | What they receive |
|---|---|---|
| infiltration anesthesia | Experimental | Not described Receives: Procedure: infiltration anesthesia alone; Procedure: infiltration anesthesia combined with cryotherapy |
| mandibular anesthesia | Experimental | Not described Receives: Procedure: mandibular anesthesia alone; Procedure: mandibular anesthesia combined with cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pain
Intraoperative pain intensity assessed using a Visual Analogue Scale (VAS) (1-10) during access cavity preparation.
Measured: Baseline/During the Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Tuğba Eminsoy Avcı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403578
- Sponsor's protocol ID
- 02
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Cryotherapy On Anesthetıc Success And Intraoperatıve Paın In Mandıbular Premolars Wıth Irreversıble Pulpıtıs: A Prospectıve Randomızed Clınıcal Trıal
- ClinicalTrials.gov ID
- NCT07403578
- Acronym / sponsor ID
- 02
- Conditions
- Irreversible Pulpitis, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Feb 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.
This prospective randomized clinical trial aimed to evaluate the effects of different anesthesia protocols on anesthetic success and intraoperative pain during root canal treatment of mandibular premolars diagnosed with symptomatic irreversible pulpitis. A total of 100 systemically healthy patients were randomly allocated into four groups: infiltration anesthesia alone, inferior alveolar nerve block (IANB) alone, infiltration anesthesia combined with cryotherapy, and IANB combined with cryotherapy. Cryotherapy was applied intraorally for 5 minutes immediately after anesthetic administration.
The effectiveness of anesthesia was confirmed using electric pulp testing and cold testing prior to treatment. Root canal therapy was completed in a single visit by a calibrated operator. Intraoperative pain was assessed during access cavity preparation using a visual analogue scale (VAS). Anesthetic success was defined as the presence of no or mild pain, whereas moderate or severe pain indicated anesthetic failure and required supplemental anesthesia.
The primary objective of the study was to determine whether the adjunctive use of cryotherapy improves anesthetic success and reduces intraoperative pain in mandibular premolars with symptomatic irreversible pulpitis. The null hypothesis was that no significant differences would be observed among the study groups in terms of anesthetic success or intraoperative pain intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infiltration anesthesia | Experimental | Procedure: infiltration anesthesia alone, Procedure: infiltration anesthesia combined with cryotherapy |
| mandibular anesthesia | Experimental | Procedure: mandibular anesthesia alone, Procedure: mandibular anesthesia combined with cryotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Systemically healthy patients classified as ASA I or II, aged between 18 and 60 years,
- Presence of a restorable mandibular premolar tooth diagnosed with symptomatic irreversible pulpitis,
- History of spontaneous pain or lingering pain elicited by thermal stimuli,
- Positive response with lingering pain to cold testing (Endo Ice; Coltene, Altstätten, Switzerland),
- Positive response at low current levels to electric pulp testing (Parkell Inc., USA),
Key exclusion criteria (8 listed)
- Patients who had taken analgesic, anti-inflammatory, or opioid medication within the last 12 hours before treatment,
- Patients with systemic conditions that may affect pain perception, inflammatory response, or healing,
- History of antibiotic use within the previous month or requirement for antibiotic prophylaxis,
- Teeth presenting with clinical or radiographic signs of pulp necrosis or apical periodontitis (Pain on percussion or palpation, presence of sinus tract or swelling, presence of periapical radiolucency),
- Teeth with root resorption, immature apices, severe coronal destruction preventing proper isolation, or calcified canals,
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 |
|---|---|---|
| infiltration anesthesia aloneLocal anesthesia was achieved using buccal infiltration with 2% lidocaine and 1:100,000 epinephrine. | Procedure or surgery | infiltration anesthesia |
| mandibular anesthesia aloneLocal anesthesia was achieved using mandibular block anesthesia with 2% lidocaine and 1:100,000 epinephrine. | Procedure or surgery | mandibular anesthesia |
| infiltration anesthesia combined with cryotherapyCryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication | Procedure or surgery | infiltration anesthesia |
| mandibular anesthesia combined with cryotherapyCryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication | Procedure or surgery | mandibular anesthesia |
Primary outcome
Intraoperative pain
Time frame: Baseline/During the Operation
Intraoperative pain intensity assessed using a Visual Analogue Scale (VAS) (1-10) during access cavity preparation.
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 11 Feb 2026.
- Individual participant dataSharing planned: No
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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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 infiltration anesthesia alone, mandibular anesthesia alone and infiltration anesthesia combined with cryotherapy in people with Irreversible Pulpitis and Cryotherapy, run by TC Erciyes 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 7 inclusion and 8 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 11 Feb 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 Ayşe Tuğba Eminsoy Avcı, Dentist (+905468725480, dtaysetugbaeminsoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative pain (time frame: Baseline/During the Operation). 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 11 Feb 2026.