Irreversible PulpitisNCT06194721
The Effect of Intra-pulpal Anesthesia With Cryotherapy on Intra-operative Pain
A study testing Cold intrapulpal anesthesia and Room temperature intrapulpal anesthesia in people with Irreversible Pulpitis, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
The goal of this clinical trial is to compare the effect of cooling of local anesthesia on intraoperative pain during root canal treatment in mandibular molars diagnosed as symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Cold intrapulpal anesthesia and Room temperature intrapulpal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 6 Jun 2023to 6 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.
- Mandibular molars with closed apices.
- Patients who are experiencing pain during access cavity drilling above 5 visual analog scale.
Who cannot join
- • Patients with a known allergy to lidocaine.
- Root canal-treated mandibular molars.
- Patients with systemic diseases.
- Mandibular molars with open apices.
- Mandibular molars with external/internal resorption.
- Non-restorable mandibular molars.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 4184
About this study
Official title: The Effect of Intra-pulpal Anesthesia With Cryotherapy on Intra-operative Pain During Root Canal Treatment on Mandibular Molars With Symptomatic Irreversible Pulpitis
The goal of this clinical trial is to compare the effect of cooling of local anesthesia on intraoperative pain during root canal treatment in mandibular molars diagnosed as symptomatic irreversible pulpitis. The main question it aims to answer is: Is there a difference in intra-operative pain levels using intra-pulpal anesthesia with and without cryotherapy during root canal treatment? Participants will undergo root canal treatment using intrapulpal anesthesia with and without cooling. Researchers will compare cold and room temperature intrapulpal anesthesia to see the intensity of intraoperative pain.
Read the detailed description
The study will be conducted on 40 mandibular molars in each group n = 20. The patient will be asked to pick an opaque sealed envelope that will contain a number 1 or 2. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the assessor and the patients will not be aware of their group.
Group 1: Will receive intrapulpal local anesthesia at 4-5 C after pulp exposure.
Group 2: Will receive intrapulpal local anesthesia at room temperature after pulp exposure.
Procedural steps:
- A history of present illness will be recorded from the patient and the suspected tooth will be tested for vitality using a cold test and an electric pulp tester, to ensure the correct diagnosis is reached.
- Once the diagnosis is confirmed to be symptomatic irreversible pulpitis, the patient will receive an inferior alveolar nerve block (2% lidocaine 1:100,000).
- A rubber dam will be used to achieve isolation, and an access cavity will be prepared using a high-speed handpiece, a round bur (no.4), and an Endo-Z bur.
- If the patient reports feeling any pain, the procedure will stop, and the patient will be presented with a Visual Analogue Scale and asked to rate the pain on a scale of 1-10. Pain levels of more than 5 will be included in the study.
- Intra-pulpal anesthesia (2% lidocaine 1:100,000) will be administered, and the needle will be surrounded by a piece of sterile gauze to ensure it is under back pressure.
- After administering the intra-pulpal injection, the patient will again be presented with the same VAS and asked to rate their current pain.
- Conditions
- Irreversible Pulpitis
- Being tested
- Cold intrapulpal anesthesia, Room temperature intrapulpal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold intrapulpal anesthesiaProcedure or surgery
Intrapulpal cold local anesthesia at 4-5 c temperature
Room temperature intrapulpal anesthesiaProcedure or surgery
Intrapulpal cold local anesthesia at room temperature
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Not described Receives: Procedure: Cold intrapulpal anesthesia |
| Room temperature | Active comparator | Not described Receives: Procedure: Room temperature intrapulpal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of intraoperative pain
Evaluation of intraoperative pain intensity using a visual analog scale. The visual analog scale measures pain intensity. The visual analog scale consists of a 10 cm line, with 2 endpoints representing 0 ( no pain) and 10 (pain as bad it could be)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start6 Jun 2023
- Primary completion6 Dec 2024
- Study completion6 Jan 2025
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194721
- Sponsor's protocol ID
- IRB-COD-STD-109-JUNE-2023
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra-pulpal Anesthesia With Cryotherapy on Intra-operative Pain During Root Canal Treatment on Mandibular Molars With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06194721
- Acronym / sponsor ID
- IRB-COD-STD-109-JUNE-2023
- Conditions
- Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 8 Jan 2024 (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 is to compare the effect of cooling of local anesthesia on intraoperative pain during root canal treatment in mandibular molars diagnosed as symptomatic irreversible pulpitis. The main question it aims to answer is: Is there a difference in intra-operative pain levels using intra-pulpal anesthesia with and without cryotherapy during root canal treatment? Participants will undergo root canal treatment using intrapulpal anesthesia with and without cooling. Researchers will compare cold and room temperature intrapulpal anesthesia to see the intensity of intraoperative pain.
Detailed description
The study will be conducted on 40 mandibular molars in each group n = 20. The patient will be asked to pick an opaque sealed envelope that will contain a number 1 or 2. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the assessor and the patients will not be aware of their group.
Group 1: Will receive intrapulpal local anesthesia at 4-5 C after pulp exposure.
Group 2: Will receive intrapulpal local anesthesia at room temperature after pulp exposure.
Procedural steps:
- A history of present illness will be recorded from the patient and the suspected tooth will be tested for vitality using a cold test and an electric pulp tester, to ensure the correct diagnosis is reached.
- Once the diagnosis is confirmed to be symptomatic irreversible pulpitis, the patient will receive an inferior alveolar nerve block (2% lidocaine 1:100,000).
- A rubber dam will be used to achieve isolation, and an access cavity will be prepared using a high-speed handpiece, a round bur (no.4), and an Endo-Z bur.
- If the patient reports feeling any pain, the procedure will stop, and the patient will be presented with a Visual Analogue Scale and asked to rate the pain on a scale of 1-10. Pain levels of more than 5 will be included in the study.
- Intra-pulpal anesthesia (2% lidocaine 1:100,000) will be administered, and the needle will be surrounded by a piece of sterile gauze to ensure it is under back pressure.
- After administering the intra-pulpal injection, the patient will again be presented with the same VAS and asked to rate their current pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Procedure: Cold intrapulpal anesthesia |
| Room temperature | Active comparator | Procedure: Room temperature intrapulpal anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.
- Mandibular molars with closed apices.
- Patients who are experiencing pain during access cavity drilling above 5 visual analog scale.
Key exclusion criteria (6 listed)
- • Patients with a known allergy to lidocaine.
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 |
|---|---|---|
| Cold intrapulpal anesthesiaIntrapulpal cold local anesthesia at 4-5 c temperature | Procedure or surgery | Cryotherapy |
| Room temperature intrapulpal anesthesiaIntrapulpal cold local anesthesia at room temperature | Procedure or surgery | Room temperature |
Primary outcome
Level of intraoperative pain
Time frame: Intraoperative
Evaluation of intraoperative pain intensity using a visual analog scale. The visual analog scale measures pain intensity. The visual analog scale consists of a 10 cm line, with 2 endpoints representing 0 ( no pain) and 10 (pain as bad it could be)
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 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold intrapulpal anesthesia and Room temperature intrapulpal anesthesia in people with Irreversible Pulpitis, run by Gulf Medical University at 1 site in United Arab Emirates.
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 3 inclusion and 6 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 Sep 2026. 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 United Arab Emirates. 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?
Level of intraoperative pain (time frame: Intraoperative). 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 14 Sep 2026.