Success of Inferior Alveolar Nerve BlockNCT04561921
Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.
A study testing Magnesium sulfate and Mepivacaine-Levonordefrin Hydrochloride in people with Success of Inferior Alveolar Nerve Block, run by Cairo University.
Trial summary
the study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Success of Inferior Alveolar Nerve Block
- What is being tested?
- Magnesium sulfate and Mepivacaine-Levonordefrin Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2020to 1 Nov 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-55 years old.
- Systemically healthy patient (ASA I or II).
- Mandibular molar teeth with:
- Preoperative sharp pain.
- No widening in the periodontal ligament (PDL).
- Vital response of pulp tissue to cold pulp tester (ethyl chloride spray)1.
- Fully formed roots.
- Positive patient's acceptance for participation in the study.
Who cannot join
- Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment.
- Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Drug abusers and subjects who were on antidepressant medication.
- Re-treatment cases.
- Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.
Trial locations and contacts
No sites are listed yet.
About this study
the study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars
- Conditions
- Success of Inferior Alveolar Nerve Block
- Being tested
- Magnesium sulfate, Mepivacaine-Levonordefrin Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Also called magnisol
patients will be given an IANB injection by adding 0.18 mL of 10% magnesium sulphate to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe
Mepivacaine-Levonordefrin HydrochlorideDrug
Also called Mepecaine - L
patients will be given an IANB injection by adding 0.18 mL of sterile distilled water to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe
| Study group | Role | What they receive |
|---|---|---|
| megnesium sulphate | Experimental | Injection of 1.8 mL of an anaesthetic solution containing 1% magnesium sulphate , and 1.8% mepivacaine HCL with .06mg Levonordefrin HCl during inferior alveolar nerve block. Receives: Drug: Magnesium sulfate |
| mepivacaine HCl | Active comparator | Injection of 1.8 mL of a local anaesthetic solution containing 1.8% mepivacaine HCL with .06mg Levonordefrin HCL during inferior alveolar nerve block Receives: Drug: Mepivacaine-Levonordefrin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of inferior alveolar nerve block measured using a numerical rating scale (NRS)
Intensity of pain 15 minutes after injection during access cavity and initial file placement is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )
Measured: 15 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start22 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Success of Inferior Alveolar Nerve BlockStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ibrahim Ibrahim Ghazy Mekhimar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561921
- Sponsor's protocol ID
- ENDO 3-7-1(18/9/20)
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04561921
- Acronym / sponsor ID
- ENDO 3-7-1(18/9/20)
- Conditions
- Success of Inferior Alveolar Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 24 Sep 2020 (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 study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| megnesium sulphate | Experimental | Drug: Magnesium sulfateInjection of 1.8 mL of an anaesthetic solution containing 1% magnesium sulphate , and 1.8% mepivacaine HCL with .06mg Levonordefrin HCl during inferior alveolar nerve block. |
| mepivacaine HCl | Active comparator | Drug: Mepivacaine-Levonordefrin HydrochlorideInjection of 1.8 mL of a local anaesthetic solution containing 1.8% mepivacaine HCL with .06mg Levonordefrin HCL during inferior alveolar nerve block |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18-55 years old.
- Systemically healthy patient (ASA I or II).
- Mandibular molar teeth with:
- Positive patient's acceptance for participation in the study.
Key exclusion criteria (6 listed)
- Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment.
- Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Drug abusers and subjects who were on antidepressant medication.
- Re-treatment cases.
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 |
|---|---|---|
| Magnesium sulfateAlso: magnisolpatients will be given an IANB injection by adding 0.18 mL of 10% magnesium sulphate to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe | Drug | megnesium sulphate |
| Mepivacaine-Levonordefrin HydrochlorideAlso: Mepecaine - Lpatients will be given an IANB injection by adding 0.18 mL of sterile distilled water to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe | Drug | mepivacaine HCl |
Primary outcome
success of inferior alveolar nerve block measured using a numerical rating scale (NRS)
Time frame: 15 minutes after injection
Intensity of pain 15 minutes after injection during access cavity and initial file placement is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate and Mepivacaine-Levonordefrin Hydrochloride in people with Success of Inferior Alveolar Nerve Block, run by Cairo 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 8 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: status not confirmed, as of the sponsor's last update on 29 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alaa Ib mekhimar, B.D.S (01096404006 ext. 002, alaa.ibrahim.ghazy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of inferior alveolar nerve block measured using a numerical rating scale (NRS) (time frame: 15 minutes after injection). 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 29 Sep 2020.