Child BehaviorNCT05334433
Child Behavior After Local Anesthetic Injection Using Needless Systems
A study testing Local anesthesia injection in people with Child Behavior, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- Local anesthesia injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2022to 20 May 2023
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.
- Children who are medically fit.
- Children who are capable of interacting on a mental level.
- Children between the ages of 6 to 8.
- First dental visit.
Who cannot join
- Children who struggle with behavioral control (uncooperative).
- Children who have a history of allergic reaction to local anesthetic drugs.
- Parental rejection for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Child Behavior and Soft Tissue Reaction After Local Anesthetic Injection Using Needle Versus Needless Systems
The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique
- Conditions
- Child Behavior
- Being tested
- Local anesthesia injection
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia injectionProcedure or surgery
Local anesthesia administration
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia injection with the comfort in jet (Needless system) | Experimental | A needle-less injection approach will be used to administer the local anesthetic solution Receives: Procedure: Local anesthesia injection |
| Local anesthesia injection with needle injection (conventional technique). | Active comparator | A conventional aspirating syringe fitted with 27-gauge long needles will be used to administer the local anesthetic solution. Receives: Procedure: Local anesthesia injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child behavior (Feeling pain during injection) (Binary Yes/No)
Pain perception during LA injection
Measured: During injection (Immediate) (No follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start20 Sep 2022
- Primary completion20 Dec 2022
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayatallah Elsayed Mohamed Aly Bassiouny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334433
- Sponsor's protocol ID
- 3399444
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Child Behavior and Soft Tissue Reaction After Local Anesthetic Injection Using Needle Versus Needless Systems
- ClinicalTrials.gov ID
- NCT05334433
- Acronym / sponsor ID
- 3399444
- Conditions
- Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 19 Apr 2022 (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 this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia injection with the comfort in jet (Needless system) | Experimental | Procedure: Local anesthesia injectionA needle-less injection approach will be used to administer the local anesthetic solution |
| Local anesthesia injection with needle injection (conventional technique). | Active comparator | Procedure: Local anesthesia injectionA conventional aspirating syringe fitted with 27-gauge long needles will be used to administer the local anesthetic solution. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.
- Children who are medically fit.
- Children who are capable of interacting on a mental level.
- Children between the ages of 6 to 8.
- First dental visit.
Key exclusion criteria (3 listed)
- Children who struggle with behavioral control (uncooperative).
- Children who have a history of allergic reaction to local anesthetic drugs.
- Parental rejection for participation.
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 |
|---|---|---|
| Local anesthesia injectionLocal anesthesia administration | Procedure or surgery | Local anesthesia injection with needle injection (conventional technique)., Local anesthesia injection with the comfort in jet (Needless system) |
Primary outcome
Child behavior (Feeling pain during injection) (Binary Yes/No)
Time frame: During injection (Immediate) (No follow up)
Pain perception during LA injection
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 13 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia injection in people with Child Behavior, 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 5 inclusion and 3 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 13 Sep 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.
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?
Child behavior (Feeling pain during injection) (Binary Yes/No) (time frame: During injection (Immediate) (No follow up)). 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 13 Sep 2023.