Local AnesthesiaPhase 2NCT03262857
Effect of Lidocaine With Magnesium Sulfate on the Success of the Inferior Alveolar Nerve Block
A Phase 2 study testing use of magnesium sulfate with lidocaine in inferior alveolar nerve block in people with Local Anesthesia, run by Isfahan University of Medical Sciences.
Trial summary
68 healthy patients pulpitis and requiring root canal therapy are selected. . Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and then the samples were randomly assigned to one of the two experimental groups (A, B) using simple random numbers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- use of magnesium sulfate with lidocaine in inferior alveolar nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2016to 21 Sep 2018
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- absence of periodontal disease
- absence of susceptibility to local anesthetics or sulfite
- non-pregnant women and non-lactating women
Who cannot join
- Clinical observation of necrotic pulp
- the patient's inability to give informed consent and patient's continuation of the research in each stage of the trial.
About this study
Official title: Comparison of the Success Rate of Anesthesia Between Lidocaine 2% and Lidocaine 2% Mixed With 10% Magnesium Sulfate in the Inferior Alveolar Nerve Block in Posterior Teeth With Irreversible Pulpitis
68 healthy patients pulpitis and requiring root canal therapy are selected. . Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and then the samples were randomly assigned to one of the two experimental groups (A, B) using simple random numbers.
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design, and each letter A or B is written. This statement is not decoded after the statistical examination. Therefore, the study is blind and blind. In this way, 60 patients are examined in 2 groups of 34 First, patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given. Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent. After completing the patient information form by the practitioner and complying with all entry and exit criteria, the study begins on each patient.
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale (VAS). This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain. In order to design a standard injection of the maxillary nerve block in all patients, using Aspirating Dental Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject, Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the syringe body in the perimmel area of the opposite side), and after the aspiration of the contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of numbness of the lips, the patient begins to study and the access cavity begins on the desired tooth. In each of the stages of acquiring the access cavity or entering the initial file to the canal, in the event of pain, the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over. In the absence of anesthetized lips, the patient is excluded from the study and after completing the injection, the root canal is given.
Read the detailed description
68 healthy patients (ASA I, II, and over the age of 18 and under the age of 60 years with posterior mandibular maxillary jaw and with symptomatic pulpitis (severe and long response to cold test) and requiring root canal therapy are selected. .
The criteria for entering the study include: absence of periodontal disease and any periapical radiolucency except for PDL dilation, absence of susceptibility to local anesthetic or sulfite drugs, non-pregnant women and non-lactating women, lack of drugs that interact with local anesthetic Or change the perception of pain (such as beta-blocker drugs, opiates, etc.).
Exclusion criteria included: Clinical observation of necrotic pulp after opening the access cavity in the desired tooth, the patient's inability to give informed consent and patient's continuation of the research in each stage of the trial.
Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and then the samples were randomly assigned to one of the two experimental groups (A, B) using simple random numbers.
Preparation of infiltration solution will be such that using a syringe with a high accuracy (hamilton) of 0.2 ml of magnesium 10% sulfate vial or distilled water sterilized and then into a 1.8ml cartridge of lidocaine 2% With an epinephrine 80000/1, the solution is shaken 5 times for mixing, so that no sediment should be seen.
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design, and each letter A or B is written. This statement is not decoded after the statistical examination. Therefore, the study is blind and blind. In this way, 68 patients are examined in 2 groups of 34 people. It should be noted that all anesthesia is injected by one person.
First, patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given. Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent. After completing the patient information form by the practitioner and complying with all entry and exit criteria, the study begins on each patient.
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale (VAS). This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain. In order to design a standard injection of the maxillary nerve block in all patients, using Aspirating Dental Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject, Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the syringe body in the perimmel area of the opposite side), and after the aspiration of the contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of numbness of the lips, the patient begins to study and the access cavity begins on the desired tooth. In each of the stages of acquiring the access cavity or entering the initial file to the canal, in the event of pain, the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over. In the absence of anesthetized lips, the patient is excluded from the study and after completing the injection, the root canal is given.
- Conditions
- Local Anesthesia
- Being tested
- use of magnesium sulfate with lidocaine in inferior alveolar nerve block
- Keywords
- magnesium sulfate, pulpitis, anesthesia
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of magnesium sulfate with lidocaine in inferior alveolar nerve blockDrug
| Study group | Role | What they receive |
|---|---|---|
| time of start of anesthesia | Experimental | Not described Receives: Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block |
| intensity of anesthesia | Experimental | Not described Receives: Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Magnesium with lidocaine
measuring the time of starting of anesthesia with questionnaire
Measured: 10 to 20 minute
intensity of pain
measuring pain after access cavity preparation with questionnaire
Measured: 10-20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start21 Sep 2016
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyed Amir Mousavi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262857
- Sponsor's protocol ID
- IUMS 396169
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2017
- Last updated
- 12 Aug 2019
- 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 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Success Rate of Anesthesia Between Lidocaine 2% and Lidocaine 2% Mixed With 10% Magnesium Sulfate in the Inferior Alveolar Nerve Block in Posterior Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT03262857
- Acronym / sponsor ID
- IUMS 396169
- Conditions
- Local Anesthesia
- Keywords
- magnesium sulfate, pulpitis, anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 25 Aug 2017 (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.
68 healthy patients pulpitis and requiring root canal therapy are selected. . Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and then the samples were randomly assigned to one of the two experimental groups (A, B) using simple random numbers.
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design, and each letter A or B is written. This statement is not decoded after the statistical examination. Therefore, the study is blind and blind. In this way, 60 patients are examined in 2 groups of 34 First, patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given. Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent. After completing the patient information form by the practitioner and complying with all entry and exit criteria, the study begins on each patient.
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale (VAS). This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain. In order to design a standard injection of the maxillary nerve block in all patients, using Aspirating Dental Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject, Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the syringe body in the perimmel area of the opposite side), and after the aspiration of the contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of numbness of the lips, the patient begins to study and the access cavity begins on the desired tooth. In each of the stages of acquiring the access cavity or entering the initial file to the canal, in the event of pain, the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over. In the absence of anesthetized lips, the patient is excluded from the study and after completing the injection, the root canal is given.
Detailed description
68 healthy patients (ASA I, II, and over the age of 18 and under the age of 60 years with posterior mandibular maxillary jaw and with symptomatic pulpitis (severe and long response to cold test) and requiring root canal therapy are selected. .
The criteria for entering the study include: absence of periodontal disease and any periapical radiolucency except for PDL dilation, absence of susceptibility to local anesthetic or sulfite drugs, non-pregnant women and non-lactating women, lack of drugs that interact with local anesthetic Or change the perception of pain (such as beta-blocker drugs, opiates, etc.).
Exclusion criteria included: Clinical observation of necrotic pulp after opening the access cavity in the desired tooth, the patient's inability to give informed consent and patient's continuation of the research in each stage of the trial.
Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and then the samples were randomly assigned to one of the two experimental groups (A, B) using simple random numbers.
Preparation of infiltration solution will be such that using a syringe with a high accuracy (hamilton) of 0.2 ml of magnesium 10% sulfate vial or distilled water sterilized and then into a 1.8ml cartridge of lidocaine 2% With an epinephrine 80000/1, the solution is shaken 5 times for mixing, so that no sediment should be seen.
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design, and each letter A or B is written. This statement is not decoded after the statistical examination. Therefore, the study is blind and blind. In this way, 68 patients are examined in 2 groups of 34 people. It should be noted that all anesthesia is injected by one person.
First, patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given. Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent. After completing the patient information form by the practitioner and complying with all entry and exit criteria, the study begins on each patient.
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale (VAS). This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain. In order to design a standard injection of the maxillary nerve block in all patients, using Aspirating Dental Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject, Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the syringe body in the perimmel area of the opposite side), and after the aspiration of the contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of numbness of the lips, the patient begins to study and the access cavity begins on the desired tooth. In each of the stages of acquiring the access cavity or entering the initial file to the canal, in the event of pain, the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over. In the absence of anesthetized lips, the patient is excluded from the study and after completing the injection, the root canal is given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| time of start of anesthesia | Experimental | Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block |
| intensity of anesthesia | Experimental | Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- absence of periodontal disease
- absence of susceptibility to local anesthetics or sulfite
- non-pregnant women and non-lactating women
Key exclusion criteria (2 listed)
- Clinical observation of necrotic pulp
- the patient's inability to give informed consent and patient's continuation of the research in each stage of the trial.
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 |
|---|---|---|
| use of magnesium sulfate with lidocaine in inferior alveolar nerve block | Drug | intensity of anesthesia, time of start of anesthesia |
Primary outcome
Effect of Magnesium with lidocaine
Time frame: 10 to 20 minute
measuring the time of starting of anesthesia with questionnaire
intensity of pain
Time frame: 10-20 minute
measuring pain after access cavity preparation with questionnaire
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 12 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing use of magnesium sulfate with lidocaine in inferior alveolar nerve block in people with Local Anesthesia, run by Isfahan University of Medical Sciences.
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 2 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 12 Aug 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of Magnesium with lidocaine (time frame: 10 to 20 minute). The study lists 2 primary outcomes in all. 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 12 Aug 2019.