Pulpitis - IrreversibleCryPainNCT06268912
Cryoanalgesia for Irreversible Pulpitis
A study testing Cold Mepivacaine and Mepivacaine at room temperature in people with Pulpitis - Irreversible, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Cold Mepivacaine and Mepivacaine at room temperature
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2022to 7 Jan 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Patients within the age group of 18-100 years old,
- Patients diagnosed of irreversible pulpitis.
Who cannot join
- Moderate to pulp necrosis,
- Previous initiated treatment.
- Pregnancy or lactation.
- Allergy or problems to any substances used in the study,
- Acute apical abscess.
- Chronic apical abscess.
- Unrestorable teeth.
- Unsuccessful anesthesia technique (no lip numbness for lower molars or positive response to cold test).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryoanalgesia: Temperature Modulation for Pain Management in Irreversible Pulpitis a Randomized Clinical Trial
The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis.
Read the detailed description
Mepivacaine has some advantages over other anesthetics. The investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible pulpitis.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Cold Mepivacaine, Mepivacaine at room temperature
- Keywords
- Cryoanalgesia, Irreversible Pulpitis, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold MepivacaineProcedure or surgery
change the temperature, 3% at 5ºC
Mepivacaine at room temperatureProcedure or surgery
no change the temperature of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Cold Mepivacaine | Experimental | Mepivacaine 3% at 5ºC Receives: Procedure: Cold Mepivacaine |
| Mepivacaine at room temperature | Active comparator | Mepivacaine 3% at room temperature Receives: Procedure: Mepivacaine at room temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain and Anxiety
Pain during injection, caries removal, access cavity, and instrumentation were recorded. The patients received a full description of the procedure, and patients were asked to rate their current pain and their anxiety with a descriptive scale (Heft-Parker Visual Analog Scale (VAS) before starting the treatment. A visual analog scale of 170 mm that the start points on the left side means "no pain" and the endpoint on the right side means "severe pain". The participants indicated their pain level by marking a point on the scale that best represented their experience. For data interpretation, the Visual Analog Scale (VAS) was segmented into four categories: no pain corresponded to 0 mm on the scale, mild pain as greater than 0 and ≤54mm, moderate pain defined as greater than 54 mm and less than 114 mm and severe pain defined as 114 mm or more.
Measured: 1 visit of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start7 Sep 2022
- Primary completion7 Sep 2023
- Study completion7 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Gómez Val, Universitat Internacional de Catalunya
- Investigators
- gonzalo gomez, Principal investigator, UIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268912
- Sponsor's protocol ID
- END-ECL-2022-01
- Other IDs
- END-ECL-2022-01
- Acronym
- CryPain
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoanalgesia: Temperature Modulation for Pain Management in Irreversible Pulpitis a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06268912
- Acronym / sponsor ID
- CryPain / END-ECL-2022-01
- Conditions
- Pulpitis - Irreversible
- Keywords
- Cryoanalgesia, Irreversible Pulpitis, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Jan 2024 (actual)
- First posted
- 20 Feb 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 aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis.
Detailed description
Mepivacaine has some advantages over other anesthetics. The investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Mepivacaine | Experimental | Procedure: Cold MepivacaineMepivacaine 3% at 5ºC |
| Mepivacaine at room temperature | Active comparator | Procedure: Mepivacaine at room temperatureMepivacaine 3% at room temperature |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All Patients within the age group of 18-100 years old,
- Patients diagnosed of irreversible pulpitis.
Key exclusion criteria (8 listed)
- Moderate to pulp necrosis,
- Previous initiated treatment.
- Pregnancy or lactation.
- Allergy or problems to any substances used in the study,
- Acute apical abscess.
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 Mepivacainechange the temperature, 3% at 5ºC | Procedure or surgery | Cold Mepivacaine |
| Mepivacaine at room temperatureno change the temperature of anesthesia | Procedure or surgery | Mepivacaine at room temperature |
Primary outcome
Assessment of Pain and Anxiety
Time frame: 1 visit of 1 hour
Pain during injection, caries removal, access cavity, and instrumentation were recorded. The patients received a full description of the procedure, and patients were asked to rate their current pain and their anxiety with a descriptive scale (Heft-Parker Visual Analog Scale (VAS) before starting the treatment. A visual analog scale of 170 mm that the start points on the left side means "no pain" and the endpoint on the right side means "severe pain". The participants indicated their pain level by marking a point on the scale that best represented their experience. For data interpretation, the Visual Analog Scale (VAS) was segmented into four categories: no pain corresponded to 0 mm on the scale, mild pain as greater than 0 and ≤54mm, moderate pain defined as greater than 54 mm and less than 114 mm and severe pain defined as 114 mm or more.
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 20 Feb 2024.
Related trials for Pulpitis - Irreversible
Not yet recruiting
Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis.
Pain
Recruiting
Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars
Anesthetic Efficacy
Recruiting
Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
Pulpectomy, Pulpitis - Irreversible
Recruiting
Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
Irreversible Pulpitis
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
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.
gonzalo gomez principal investigator
UIC
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 Mepivacaine and Mepivacaine at room temperature in people with Pulpitis - Irreversible, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 20 Feb 2024. 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 Spain. 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?
Assessment of Pain and Anxiety (time frame: 1 visit of 1 hour). 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 20 Feb 2024.