AnesthesiaNCT06314984
Jet Injectors Versus Conventional Anesthetic Technique in Children
A study testing Group I A (Conventional needle syringe), Group I B (Conventional needle syringe) and Group II A (Comfort-in Jet Injector) in people with Anesthesia, run by Mansoura University at 1 site in Egypt.
Trial summary
This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of 1. Pain level during the administration of local anesthesia in children. 2. Their effectiveness during pulpotomy procedures in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Group I A (Conventional needle syringe), Group I B (Conventional needle syringe) and Group II A (Comfort-in Jet Injector)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2021to 21 Mar 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who require local anesthetic injection for pulpotomy.
- Cooperative children (positive or definitely positive on Frankel's scale).
- Children who had no previous dental local anesthetic experience, to avoid the influence of a negative or positive memory.
- Children who have been determined to be healthy and free of systemic diseases.
- Children who do not have any contraindications for administering a local anesthetic agent.
Who cannot join
- Children suffering from medical illness, neurosensory disturbances, and psychiatric disorders.
- Children who could not comprehend the pain measures.
- Children with emergencies and acute dental conditions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University.
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Effectiveness of Jet Injector Local Anesthesia Versus Conventional Technique in Primary Molars Pulpotomy
This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of
- Pain level during the administration of local anesthesia in children.
- Their effectiveness during pulpotomy procedures in primary molars.
Whether comfort-in jet injector device will achieve sufficient anesthesia for the procedures undertaken during pulpotomy or not when compared to the conventional technique and the pain levels of both techniques during the anesthesia step.
Read the detailed description
Cooperative healthy seventy-six children required pulpotomy treatment in primary molars aged 4 to 7 years with no previous dental local anesthetic experience, were recruited from the pediatric dental clinic, Faculty of Dentistry, Mansoura university. The patients' behavior was categorized as positive or definitely positive according to Frankl Behavior Scale. All children were divided randomly into two main groups (38 each), control group I (conventional needle) and experimental group II (Comfort-in). Then two sub-group were constructed, each consists of 19 children. Sub-group I A and II A (IANB) and sub-group I B and II B (maxillary infiltration), the chief complaint of the child was the main determinant for the side (right or left) to be injected. The jet injector technique was applied in 2 shots with (0.5 ml) each, to unify the dose with the conventional technique. After testing the anesthesia's profoundness, pulpotomy steps proceeded. Pain evaluation was set up according to two different subjective and objective scales, the WBFP and FLACC scales. All parents of the children included in this study answered a post-treatment questionnaire to measure the degree of satisfaction regarding the technique that was selected for his/her child. Data were collected, tabulated, and statistically analyzed.
- Conditions
- Anesthesia
- Being tested
- Group I A (Conventional needle syringe), Group I B (Conventional needle syringe), Group II A (Comfort-in Jet Injector), Group II B (Comfort-in Jet Injector)
- Keywords
- Jet injector, Needle, Comfort-in, Pain perception, Needleless, Pediatric Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I A (Conventional needle syringe)Other
The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the conventional needle syringe [Inferior Alveolar Nerve Block].
Group I B (Conventional needle syringe)Other
The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the conventional needle syringe [Infiltration].
Group II A (Comfort-in Jet Injector)Device
The injection site was isolated using a cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the needleless Comfort-in jet injector [Inferior Alveolar Nerve Block].
Group II B (Comfort-in Jet Injector)Device
The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the needleless Comfort-in jet injector [Infiltration].
| Study group | Role | What they receive |
|---|---|---|
| Group I A (Conventional neddle syringe) | Active comparator | The injection was done in the mandible by the conventional needle syringe [Inferior Alveolar Nerve Block]. Receives: Other: Group I A (Conventional needle syringe) |
| Group I B (Conventional needle syringe) | Active comparator | The injection was done in the maxilla by the conventional needle syringe [Infiltration]. Receives: Other: Group I B (Conventional needle syringe) |
| Group II A (Comfort-in Jet Injector) | Experimental | The injection was done in the mandible by the needleless Comfort-in jet injector [Inferior Alveolar Nerve Block]. Receives: Device: Group II A (Comfort-in Jet Injector) |
| Group II B (Comfort-in Jet Injector) | Experimental | The injection was done in the maxilla by the needleless Comfort-in jet injector [Infiltration]. Receives: Device: Group II B (Comfort-in Jet Injector) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale
The first scale is the Wong-Baker FACES Pain Rating scale, a subjective scale. The child was shown a collection of six cartoon faces with a variety of facial expressions, from a very happy face to a very sad face. The child was given a brief explanation of each face before being told to select the one that best reflected his or her feelings while receiving local anesthesia.
Assessment of Scores:
0= No Hurt 2= Hurts Little Bit 4= Hurts Little More 6= Hurts Even More 8= Hurts Whole Lot 10= Hurts Lots the description of the faces: Face 0 is very happy because he doesn't hurt at all. Face 1 hurts just a little bit. Face 2 hurts a little more. Face 3 hurts even more. Face 4 hurts a whole lot more. Face 5 hurts as much as you can imagine, although you do not have to be crying to feel this bad.
Measured: During adminstration of local anesthesia procedures.
Pain levels during pulpotomy procedures steps by Wong-Baker faces pain rating scale
The first scale is the Wong-Baker FACES Pain Rating scale, a subjective scale. The child was shown a collection of six cartoon faces with a variety of facial expressions, from a very happy face to a very sad face. The child was given a brief explanation of each face before being told to select the one that best reflected his or her feelings during the steps of pulpotomy procedure.
Assessment of Scores:
0= No Hurt 2= Hurts Little Bit 4= Hurts Little More 6= Hurts Even More 8= Hurts Whole Lot 10= Hurts Lots the description of the faces: Face 0 is very happy because he doesn't hurt at all. Face 1 hurts just a little bit. Face 2 hurts a little more. Face 3 hurts even more. Face 4 hurts a whole lot more. Face 5 hurts as much as you can imagine, although you do not have to be crying to feel this bad.
Measured: During the pulpotomy procedure.
Pain level during administration of local anesthesia in children by FLACC scale.
The second scale is theFace, Legs, Activity, Cry, and Consolability [FLACC scale], an objective scale, which was used to measure pain according to Face, Legs, Activity, Cry, and Consolability. An assistant was well-trained to measure and calibrate the FLACC scale during the administration of anesthesia. Each category receives a score between 0 and 2, giving a final score between 0 and 10.Assessment of Scores:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Measured: During adminstration of local anesthesia procedures.
Pain levels during pulpotomy procedures steps by FLACC scale.
The second scale is the Face, Legs, Activity, Cry, and Consolability [FLACC scale], an objective scale, which was used to measure pain according to Face, Legs, Activity, Cry, and Consolability. An assistant was well-trained to measure and calibrate the FLACC scale during the pulpotomy procedure. Each category receives a score between 0 and 2, giving a final score between 0 and 10.Assessment of Scores:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Measured: During the pulpotomy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start21 Jul 2021
- Primary completion15 Nov 2022
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Elbadry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314984
- Sponsor's protocol ID
- A10040521
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Jet Injector Local Anesthesia Versus Conventional Technique in Primary Molars Pulpotomy
- ClinicalTrials.gov ID
- NCT06314984
- Acronym / sponsor ID
- A10040521
- Conditions
- Anesthesia
- Keywords
- Jet injector, Needle, Comfort-in, Pain perception, Needleless, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 18 Mar 2024 (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.
This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of
- Pain level during the administration of local anesthesia in children.
- Their effectiveness during pulpotomy procedures in primary molars.
Whether comfort-in jet injector device will achieve sufficient anesthesia for the procedures undertaken during pulpotomy or not when compared to the conventional technique and the pain levels of both techniques during the anesthesia step.
Detailed description
Cooperative healthy seventy-six children required pulpotomy treatment in primary molars aged 4 to 7 years with no previous dental local anesthetic experience, were recruited from the pediatric dental clinic, Faculty of Dentistry, Mansoura university. The patients' behavior was categorized as positive or definitely positive according to Frankl Behavior Scale. All children were divided randomly into two main groups (38 each), control group I (conventional needle) and experimental group II (Comfort-in). Then two sub-group were constructed, each consists of 19 children. Sub-group I A and II A (IANB) and sub-group I B and II B (maxillary infiltration), the chief complaint of the child was the main determinant for the side (right or left) to be injected. The jet injector technique was applied in 2 shots with (0.5 ml) each, to unify the dose with the conventional technique. After testing the anesthesia's profoundness, pulpotomy steps proceeded. Pain evaluation was set up according to two different subjective and objective scales, the WBFP and FLACC scales. All parents of the children included in this study answered a post-treatment questionnaire to measure the degree of satisfaction regarding the technique that was selected for his/her child. Data were collected, tabulated, and statistically analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I A (Conventional neddle syringe) | Active comparator | Other: Group I A (Conventional needle syringe)The injection was done in the mandible by the conventional needle syringe [Inferior Alveolar Nerve Block]. |
| Group I B (Conventional needle syringe) | Active comparator | Other: Group I B (Conventional needle syringe)The injection was done in the maxilla by the conventional needle syringe [Infiltration]. |
| Group II A (Comfort-in Jet Injector) | Experimental | Device: Group II A (Comfort-in Jet Injector)The injection was done in the mandible by the needleless Comfort-in jet injector [Inferior Alveolar Nerve Block]. |
| Group II B (Comfort-in Jet Injector) | Experimental | Device: Group II B (Comfort-in Jet Injector)The injection was done in the maxilla by the needleless Comfort-in jet injector [Infiltration]. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children who require local anesthetic injection for pulpotomy.
- Cooperative children (positive or definitely positive on Frankel's scale).
- Children who had no previous dental local anesthetic experience, to avoid the influence of a negative or positive memory.
- Children who have been determined to be healthy and free of systemic diseases.
- Children who do not have any contraindications for administering a local anesthetic agent.
Key exclusion criteria (3 listed)
- Children suffering from medical illness, neurosensory disturbances, and psychiatric disorders.
- Children who could not comprehend the pain measures.
- Children with emergencies and acute dental conditions.
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 |
|---|---|---|
| Group I A (Conventional needle syringe)The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the conventional needle syringe [Inferior Alveolar Nerve Block]. | Other | Group I A (Conventional neddle syringe) |
| Group I B (Conventional needle syringe)The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the conventional needle syringe [Infiltration]. | Other | Group I B (Conventional needle syringe) |
| Group II A (Comfort-in Jet Injector)The injection site was isolated using a cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the needleless Comfort-in jet injector [Inferior Alveolar Nerve Block]. | Device | Group II A (Comfort-in Jet Injector) |
| Group II B (Comfort-in Jet Injector)The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the needleless Comfort-in jet injector [Infiltration]. | Device | Group II B (Comfort-in Jet Injector) |
Primary outcome
Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale
Time frame: During adminstration of local anesthesia procedures.
The first scale is the Wong-Baker FACES Pain Rating scale, a subjective scale. The child was shown a collection of six cartoon faces with a variety of facial expressions, from a very happy face to a very sad face. The child was given a brief explanation of each face before being told to select the one that best reflected his or her feelings while receiving local anesthesia. Assessment of Scores: 0= No Hurt 2= Hurts Little Bit 4= Hurts Little More 6= Hurts Even More 8= Hurts Whole Lot 10= Hurts Lots the description of the faces: Face 0 is very happy because he doesn't hurt at all. Face 1 hurts just a little bit. Face 2 hurts a little more. Face 3 hurts even more. Face 4 hurts a whole lot more. Face 5 hurts as much as you can imagine, although you do not have to be crying to feel this bad.
Pain levels during pulpotomy procedures steps by Wong-Baker faces pain rating scale
Time frame: During the pulpotomy procedure.
The first scale is the Wong-Baker FACES Pain Rating scale, a subjective scale. The child was shown a collection of six cartoon faces with a variety of facial expressions, from a very happy face to a very sad face. The child was given a brief explanation of each face before being told to select the one that best reflected his or her feelings during the steps of pulpotomy procedure. Assessment of Scores: 0= No Hurt 2= Hurts Little Bit 4= Hurts Little More 6= Hurts Even More 8= Hurts Whole Lot 10= Hurts Lots the description of the faces: Face 0 is very happy because he doesn't hurt at all. Face 1 hurts just a little bit. Face 2 hurts a little more. Face 3 hurts even more. Face 4 hurts a whole lot more. Face 5 hurts as much as you can imagine, although you do not have to be crying to feel this bad.
Pain level during administration of local anesthesia in children by FLACC scale.
Time frame: During adminstration of local anesthesia procedures.
The second scale is theFace, Legs, Activity, Cry, and Consolability [FLACC scale], an objective scale, which was used to measure pain according to Face, Legs, Activity, Cry, and Consolability. An assistant was well-trained to measure and calibrate the FLACC scale during the administration of anesthesia. Each category receives a score between 0 and 2, giving a final score between 0 and 10.Assessment of Scores: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Pain levels during pulpotomy procedures steps by FLACC scale.
Time frame: During the pulpotomy procedure.
The second scale is the Face, Legs, Activity, Cry, and Consolability [FLACC scale], an objective scale, which was used to measure pain according to Face, Legs, Activity, Cry, and Consolability. An assistant was well-trained to measure and calibrate the FLACC scale during the pulpotomy procedure. Each category receives a score between 0 and 2, giving a final score between 0 and 10.Assessment of Scores: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
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 18 Mar 2024.
- 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.
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 Group I A (Conventional needle syringe), Group I B (Conventional needle syringe) and Group II A (Comfort-in Jet Injector) in people with Anesthesia, run by Mansoura 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 18 Mar 2024. 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?
Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale (time frame: During adminstration of local anesthesia procedures.). The study lists 4 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 18 Mar 2024.