AnesthesiaNCT06001710
Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars
A study testing Needleless jet injector in people with Anesthesia, run by Suez Canal University at 1 site in Egypt.
Trial summary
To evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and Venham's anxiety and behavioral rating scale.. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Needleless jet injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Sep 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy children.
- Children aged from 4-8 years old.
- Both boys and girls were included
- Children scored (2 or 3) Frankle behavior rating scale.
- Children had bilateral deep carious lower second primary molars indicated clinically and radiographically for vital pulpotomy
- Informed consent was included from parents or caregivers.
Who cannot join
- Children with evidence of allergy to any materials used in this study
- Clinical criteria:
- Clinical history of spontaneous pain, intra-oral facial swelling or presence of fistula or sinus tract.
- Tooth with irreversible pulpitis, determined as continuous bleeding exceeding 5 minutes, dark to purple blood color or pulp necrosis.
- Radiographic criteria:
- Presence of any signs of internal or external root resorption, furcation radiolucency or periapical pathosis as revealed by preoperative periapical radiography.
- -
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and Venham's anxiety and behavioral rating scale..
Read the detailed description
One of the most effective ways to control pain during invasive dental procedures is the use of local anesthesia which considers the most painful phase of treatment. The idea of receiving an injection is fear-inducing for many individuals, both children and adults which can lead patients to avoid dental treatments. Although such fears are outside the control of dentists, some treatment aspects can be modified to increase patient comfort.(1)
Dental care may be associated with pain which may be intertwined with fear and anxiety, especially among children with treatment needs. The pain intensity is multiplied by having higher dental anxiety, a disability, age less than 14 years old and gender (female). The young patient's pain expectations may also add to the situational complexity. Consequently, dental health care may be perceived as insurmountable problem. (2) Administrating an anesthetic agent with a traditional syringe causes discomfort during the puncture and injection stages. (3) Incorrect handling of the syringe is a determining factor for pain (4), which is exacerbated due to excessive pressure on the plunger and rapid injection of large volumes of anesthetic solution.(5)
To minimize the painful sensation during local anesthesia, other methods can be adopted, such as applying topical anesthetics prior to injection (6), using computerized injection systems, and using needleless jet injection systems (7). A needleless system includes a spring coupled to an apparatus that generates sufficient Pressure to (8) push the plunger of the ampoule (9)and makes the anesthetic solution pass through a micro orifice at high speed.
The absence of a needle in a jet injection can result in a more comfortable experience, as this eliminates the puncture and injection phases, which are considered the most painful steps during traditional anesthesia (3). This difference is important as approximately one in five adults have phobia of dental anesthesia due to fear of injections, which leads to interruption of dental treatment (10).
Since there are no studies about the efficacy of needleless jet injection systems during pulpotomy of lower second primary molars, the aim of this clinical trial was to evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars
- Conditions
- Anesthesia
- Being tested
- Needleless jet injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needleless jet injectorDevice
Device consist of injection pen, ampule and activator.
| Study group | Role | What they receive |
|---|---|---|
| classic inferior alveolar nerve block anesthesia | Active comparator | Inferior alveolar nerve block (IANB) is a technique of dental anesthesia, used to produce anesthesia of the mandibular teeth, gingivae of the mandible and lower lip. The conventional IANB is the most commonly used the nerve block technique for achieving local anesthesia for mandibular surgical procedures using long needle Receives: Device: Needleless jet injector |
| needleless jet injector anesthesia | Experimental | Jet injection technology uses mechanical energy to force a liquid drug into subcutaneous tissues without a needle using infiltration technique Receives: Device: Needleless jet injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts"
Measured: After local anesthesia and during pulpotomy
Venham's anxiety and behavioral rating scale
assess the anxiety and uncooperative behavior of children in the dental setting.consist of five behavioral defined categories ranging from 0 to 5 with higher score, indicating greater level of anxiety or lack of cooperation.
Measured: After local anesthesia and during pulpotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Feb 2022
- Primary completion1 Aug 2022
- Study completion1 Sep 2022
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 Suez Canal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001710
- Sponsor's protocol ID
- Jet injector anesthesia
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 21 Aug 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars
- ClinicalTrials.gov ID
- NCT06001710
- Acronym / sponsor ID
- Jet injector anesthesia
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Aug 2023 (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.
To evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and Venham's anxiety and behavioral rating scale..
Detailed description
One of the most effective ways to control pain during invasive dental procedures is the use of local anesthesia which considers the most painful phase of treatment. The idea of receiving an injection is fear-inducing for many individuals, both children and adults which can lead patients to avoid dental treatments. Although such fears are outside the control of dentists, some treatment aspects can be modified to increase patient comfort.(1)
Dental care may be associated with pain which may be intertwined with fear and anxiety, especially among children with treatment needs. The pain intensity is multiplied by having higher dental anxiety, a disability, age less than 14 years old and gender (female). The young patient's pain expectations may also add to the situational complexity. Consequently, dental health care may be perceived as insurmountable problem. (2) Administrating an anesthetic agent with a traditional syringe causes discomfort during the puncture and injection stages. (3) Incorrect handling of the syringe is a determining factor for pain (4), which is exacerbated due to excessive pressure on the plunger and rapid injection of large volumes of anesthetic solution.(5)
To minimize the painful sensation during local anesthesia, other methods can be adopted, such as applying topical anesthetics prior to injection (6), using computerized injection systems, and using needleless jet injection systems (7). A needleless system includes a spring coupled to an apparatus that generates sufficient Pressure to (8) push the plunger of the ampoule (9)and makes the anesthetic solution pass through a micro orifice at high speed.
The absence of a needle in a jet injection can result in a more comfortable experience, as this eliminates the puncture and injection phases, which are considered the most painful steps during traditional anesthesia (3). This difference is important as approximately one in five adults have phobia of dental anesthesia due to fear of injections, which leads to interruption of dental treatment (10).
Since there are no studies about the efficacy of needleless jet injection systems during pulpotomy of lower second primary molars, the aim of this clinical trial was to evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic inferior alveolar nerve block anesthesia | Active comparator | Device: Needleless jet injectorInferior alveolar nerve block (IANB) is a technique of dental anesthesia, used to produce anesthesia of the mandibular teeth, gingivae of the mandible and lower lip. The conventional IANB is the most commonly used the nerve block technique for achieving local anesthesia for mandibular surgical procedures using long needle |
| needleless jet injector anesthesia | Experimental | Device: Needleless jet injectorJet injection technology uses mechanical energy to force a liquid drug into subcutaneous tissues without a needle using infiltration technique |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Apparently healthy children.
- Children aged from 4-8 years old.
- Both boys and girls were included
- Children scored (2 or 3) Frankle behavior rating scale.
- Children had bilateral deep carious lower second primary molars indicated clinically and radiographically for vital pulpotomy
Key exclusion criteria (7 listed)
- Children with evidence of allergy to any materials used in this study
- Clinical criteria:
- Clinical history of spontaneous pain, intra-oral facial swelling or presence of fistula or sinus tract.
- Tooth with irreversible pulpitis, determined as continuous bleeding exceeding 5 minutes, dark to purple blood color or pulp necrosis.
- Radiographic criteria:
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 |
|---|---|---|
| Needleless jet injectorDevice consist of injection pen, ampule and activator. | Device | classic inferior alveolar nerve block anesthesia, needleless jet injector anesthesia |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: After local anesthesia and during pulpotomy
a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts"
Venham's anxiety and behavioral rating scale
Time frame: After local anesthesia and during pulpotomy
assess the anxiety and uncooperative behavior of children in the dental setting.consist of five behavioral defined categories ranging from 0 to 5 with higher score, indicating greater level of anxiety or lack of cooperation.
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 21 Aug 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 Needleless jet injector in people with Anesthesia, run by Suez Canal 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 7 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 21 Aug 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?
Wong-Baker FACES Pain Rating Scale (time frame: After local anesthesia and during pulpotomy). 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 21 Aug 2023.