Local AnesthesiaPhase 3NCT04477317
Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L in Children
A Phase 3 study testing 4% Articaine Hydrochloride with 1:100,000 Adrenaline and 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin in people with Local Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- 4% Articaine Hydrochloride with 1:100,000 Adrenaline and 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 30 Oct 2021
- Phase
- Phase 3
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically fit (ASA I, II).
- Mentally capable of communication.
- Children aged 5-7 years, children older than 8 years old will not be included due to physiologic root resorption associated with shedding which may simplify the extraction procedure(25).
- First maxillary primary molar needs extraction due to root caries "beyond possible repair".
- First dental visit.
- Child must give assent prior to participation, as well as approved parental informed written consent.
Who cannot join
- Children with acute or sub-acute dento-alveolar abscess Children with history of prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.
- Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children
The aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars.
Read the detailed description
To our knowledge, no clinical trials in literature have been done to compare anesthetic efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly decayed upper first primary molars. Thus, the purpose of the present study was to fill this knowledge gap.
This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine anesthetic solution where no clinical trials have been conducted on it yet in literature.
- Conditions
- Local Anesthesia
- Being tested
- 4% Articaine Hydrochloride with 1:100,000 Adrenaline, 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% Articaine Hydrochloride with 1:100,000 AdrenalineDrug
Also called %4 Alexadricaine
new Egyptian articane anesthetic solution.
2% Mepivacaine Hydrochloride with 1:20,000 LevonordefrinDrug
Also called 2% Mepicaine-L
Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt). Receives: Drug: 4% Articaine Hydrochloride with 1:100,000 Adrenaline |
| Control | Active comparator | 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt) Receives: Drug: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative pain during extraction
measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
onset of anesthesia
measured in minutes using stopwatch
Measured: through study completion, an average of 1 year
duration of anesthesia
measured in minutes using stopwatch
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Aug 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Mostafa Mahmoud, Cairo University
- Investigators
- Sara A mahmoud, Assoc. Prof., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477317
- Sponsor's protocol ID
- local anesthesia in chilldren
- Status last verified
- Mar 2023
- First submitted
- 13 Jul 2020
- Last updated
- 14 Mar 2023
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children
- ClinicalTrials.gov ID
- NCT04477317
- Acronym / sponsor ID
- local anesthesia in chilldren
- Conditions
- Local Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 20 Jul 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 aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars.
Detailed description
To our knowledge, no clinical trials in literature have been done to compare anesthetic efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly decayed upper first primary molars. Thus, the purpose of the present study was to fill this knowledge gap.
This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine anesthetic solution where no clinical trials have been conducted on it yet in literature.
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 |
|---|---|---|
| Experimental | Experimental | Drug: 4% Articaine Hydrochloride with 1:100,000 Adrenaline4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt). |
| Control | Active comparator | Drug: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt) |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Medically fit (ASA I, II).
- Mentally capable of communication.
- Children aged 5-7 years, children older than 8 years old will not be included due to physiologic root resorption associated with shedding which may simplify the extraction procedure(25).
- First maxillary primary molar needs extraction due to root caries "beyond possible repair".
- First dental visit.
Key exclusion criteria (2 listed)
- Children with acute or sub-acute dento-alveolar abscess Children with history of prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.
- Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
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 |
|---|---|---|
| 4% Articaine Hydrochloride with 1:100,000 AdrenalineAlso: %4 Alexadricainenew Egyptian articane anesthetic solution. | Drug | Experimental |
| 2% Mepivacaine Hydrochloride with 1:20,000 LevonordefrinAlso: 2% Mepicaine-LMepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost. | Drug | Control |
Primary outcome
Intra-operative pain during extraction
Time frame: through study completion, an average of 1 year
measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale
2 secondary outcomes
onset of anesthesia
Time frame: through study completion, an average of 1 year
duration of anesthesia
Time frame: through study completion, an average of 1 year
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 Mar 2023.
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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.
Sara A mahmoud, Assoc. Prof. study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 4% Articaine Hydrochloride with 1:100,000 Adrenaline and 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin in people with Local Anesthesia, run by Cairo University at 1 site in Egypt.
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 6 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 14 Mar 2023. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Intra-operative pain during extraction (time frame: through study completion, an average of 1 year). 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 Mar 2023.