Behaviour AssessmentPhase 1/2NCT04061265
Articaine Efficacy and Safety for Children Below Age of 4-years
A Phase 1/2 study testing Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml and lidocaine hydrochloride 2% and epinephrine 1:100000 in people with Behaviour Assessment and Pain, run by Minia University at 1 site in Egypt.
Trial summary
Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Read more about this study
- Who is it for?
- Ages 37 to 47 months
- Conditions the study is for
- Behaviour Assessment, Pain
- What is being tested?
- Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml and lidocaine hydrochloride 2% and epinephrine 1:100000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2019to 15 Jan 2020
- Phase
- Phase 1/2
- 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 37 to 47 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.
Who cannot join
- The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial
Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.
- Conditions
- Behaviour Assessment, Pain
- Being tested
- Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml, lidocaine hydrochloride 2% and epinephrine 1:100000
- Keywords
- Articaine, local anaesthesia, child, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine 4%/Epi 1:100000 Inj Cart 1.7MlDrug
Local anesthetic agent
lidocaine hydrochloride 2% and epinephrine 1:100000Drug
Local anesthetic agent
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 2% group | Active comparator | lidocaine hydrochloride 2% and epinephrine 1:100000 (Lignospan® standard, 1.7ml, SEPTODONT Ltd) Receives: Drug: lidocaine hydrochloride 2% and epinephrine 1:100000 |
| Articaine 4% | Experimental | articaine hydrochloride 4% and epinephrine 1:100000 (Septocaine® 1.7ml, SEPTODONT Ltd) Receives: Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
FLACC scale
Measured: During the procedures
Behavior
Frankl behaviour scale
Measured: before and after the procedures
Secondary outcomes (1)
postoperative complications
Asking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM)
Measured: 24 hours after the procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start25 Aug 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behaviour AssessmentStudies of the same condition, open and under way.
- More trials run by Minia 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Elheeny, Minia University
- Investigators
- Ahmad Elheeny, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061265
- Sponsor's protocol ID
- 245
- Status last verified
- Feb 2020
- First submitted
- 15 Aug 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04061265
- Acronym / sponsor ID
- 245
- Conditions
- Behaviour Assessment, Pain
- Keywords
- Articaine, local anaesthesia, child, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 19 Aug 2019 (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.
Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 2% group | Active comparator | Drug: lidocaine hydrochloride 2% and epinephrine 1:100000lidocaine hydrochloride 2% and epinephrine 1:100000 (Lignospan® standard, 1.7ml, SEPTODONT Ltd) |
| Articaine 4% | Experimental | Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Mlarticaine hydrochloride 4% and epinephrine 1:100000 (Septocaine® 1.7ml, SEPTODONT Ltd) |
Who may qualify
- Ages
- 37 to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.
Key exclusion criteria (1 listed)
- The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness
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 |
|---|---|---|
| Articaine 4%/Epi 1:100000 Inj Cart 1.7MlLocal anesthetic agent | Drug | Articaine 4% |
| lidocaine hydrochloride 2% and epinephrine 1:100000Local anesthetic agent | Drug | Lidocaine 2% group |
Primary outcome
Pain assessment
Time frame: During the procedures
FLACC scale
Behavior
Time frame: before and after the procedures
Frankl behaviour scale
1 secondary outcome
postoperative complications
Time frame: 24 hours after the procedures
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 17 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Ahmad Elheeny principal investigator
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 1/2 study testing Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml and lidocaine hydrochloride 2% and epinephrine 1:100000 in people with Behaviour Assessment and Pain, run by Minia 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 1 inclusion and 1 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 17 Feb 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pain assessment (time frame: During the procedures). 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 17 Feb 2020.