PainNCT05101785
Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years
A study testing Lidocain hydrochloride 2 % with epinephrine and Articaine chloride 4% with epinephrine in people with Pain and Behavior, run by Mahmoud Ahmed Mahmoud.
Trial summary
compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- What is being tested?
- Lidocain hydrochloride 2 % with epinephrine and Articaine chloride 4% with epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2022
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children
- 3-6 years
- primary molar indicated for pulpotomy
- body weight not less than 15 Kg
Who cannot join
- Intellectual problem
- sever emotional problems
- previous dental experience
- Medically or mentally compromised children
About this study
Official title: Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years.
compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.
- Being tested
- Lidocain hydrochloride 2 % with epinephrine, Articaine chloride 4% with epinephrine
- Medical subject headings
- Pain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocain hydrochloride 2 % with epinephrineDrug
Local anesthesia infilteration in children
Articaine chloride 4% with epinephrineDrug
Articaine chloride 4% with epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Lidocain hydrochloride 2 %with epinephrine 1:100000 Receives: Drug: Lidocain hydrochloride 2 % with epinephrine |
| Articaine | Experimental | Articaine chloride 4% with epinephrine 1:100000 Receives: Drug: Articaine chloride 4% with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra and post operative pain
Evaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale
Measured: 30-60 minutes
Behavior
Evaluate child behavior using frankl scale during treatment
Measured: 30-60 minutes
Blood pressure
Vital signs
Measured: 30-60 minutes
Heart rate
Vital signs
Measured: 30-60 minutes
Respiratory rate measuring during treatment
Vital signs
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Ahmed Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Ahmed Mahmoud, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101785
- Sponsor's protocol ID
- 3081
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years.
- ClinicalTrials.gov ID
- NCT05101785
- Acronym / sponsor ID
- 3081
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Mahmoud Ahmed MahmoudUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 1 Nov 2021 (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.
compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocain hydrochloride 2 % with epinephrineLidocain hydrochloride 2 %with epinephrine 1:100000 |
| Articaine | Experimental | Drug: Articaine chloride 4% with epinephrineArticaine chloride 4% with epinephrine 1:100000 |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children
- 3-6 years
- primary molar indicated for pulpotomy
- body weight not less than 15 Kg
Key exclusion criteria (4 listed)
- Intellectual problem
- sever emotional problems
- previous dental experience
- Medically or mentally compromised children
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 |
|---|---|---|
| Lidocain hydrochloride 2 % with epinephrineLocal anesthesia infilteration in children | Drug | Lidocaine |
| Articaine chloride 4% with epinephrineArticaine chloride 4% with epinephrine | Drug | Articaine |
Primary outcome
Intra and post operative pain
Time frame: 30-60 minutes
Evaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale
Behavior
Time frame: 30-60 minutes
Evaluate child behavior using frankl scale during treatment
Blood pressure
Time frame: 30-60 minutes
Vital signs
Heart rate
Time frame: 30-60 minutes
Vital signs
Respiratory rate measuring during treatment
Time frame: 30-60 minutes
Vital signs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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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 study testing Lidocain hydrochloride 2 % with epinephrine and Articaine chloride 4% with epinephrine in people with Pain and Behavior, run by Mahmoud Ahmed Mahmoud.
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 4 inclusion and 4 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 1 Nov 2021. 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?
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 and post operative pain (time frame: 30-60 minutes). The study lists 5 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 1 Nov 2021.