Dental PhobiaNCT05899296
Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe
A study testing dental syringe ( NumBee) and Traditional dental syringe in people with Dental Phobia and Dental Anxiety, run by Duaa Kamal Naji at 1 site in Iraq.
Trial summary
The study was conducted among a group of dental patients aged (6-8 years old) of both genders to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE) compared to traditional local anesthesia: 1. Pain perception. 2. Pain related behaviors. 3. Dental anxiety 4. Anesthetic efficiency. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Phobia, Dental Anxiety, Anesthesia, Local
- What is being tested?
- dental syringe ( NumBee) and Traditional dental syringe
- 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 siteIraq
- Study dates
- 15 Mar 2022to 30 Aug 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 1. Mentally and medically compromised child. 2. Patient on medication that effect on the pain perception. 3. History of allergy to L.A.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)
The study was conducted among a group of dental patients aged (6-8 years old) of both genders to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE) compared to traditional local anesthesia:
- Pain perception.
- Pain related behaviors.
- Dental anxiety
- Anesthetic efficiency.
- Patient acceptance and preference
Read the detailed description
The prevalent phobia of needles and the associated rise in dental anxiety when using the traditional needle method of LA infiltration, the development of needle-free alternatives for local anesthetics became an urgent necessity. The NumBee (BioDent, Simi Valley, CA) is a new gadget that promises less pain administration of local anesthetic without the use of a hypodermic needle. It is a tiny metal cannula with a silicone-like covering that is used for intraligmentary injection without penetrating the periodontal ligament. This study was performed due to the lack of sufficient research on NumBee and since it meets a number of exceptional criteria, including being able to anesthetize just one tooth without having to do so for the entire alveolar dental nerve and having a needleless design that may be more appealing to children than the distressing appearance of traditional dental syringes.
- Conditions
- Dental Phobia, Dental Anxiety, Anesthesia, Local, Needle Phobia
- Being tested
- dental syringe ( NumBee), Traditional dental syringe
- Keywords
- Dental anxiety, Pain perception, Anesthetic efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental syringe ( NumBee)Device
assess the capability of NumBee to reduce anxiety and pain during injection
Traditional dental syringeDevice
compare the level of anxiety of the traditional dental syringe and the Number dental syringe
| Study group | Role | What they receive |
|---|---|---|
| Traditional syringe | Active comparator | Dental anesthesia delivered by a traditional syringe Receives: Device: Traditional dental syringe |
| NumBee | Experimental | Dental anesthesia delivered by a novel needle-less syringe Receives: Device: dental syringe ( NumBee) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain perception
checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 Mar 2022
- Primary completion1 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PhobiaStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duaa Kamal Naji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duaa Kamal Naji, University of Baghdad
- Investigators
- Duaa K Naji, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899296
- Sponsor's protocol ID
- 576322
- Status last verified
- Jun 2023
- First submitted
- 8 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be my pleasure to share and information with other resaercher
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05899296
- Acronym / sponsor ID
- 576322
- Conditions
- Dental Phobia, Dental Anxiety, Anesthesia, Local, Needle Phobia
- Keywords
- Dental anxiety, Pain perception, Anesthetic efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duaa Kamal NajiUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 12 Jun 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.
The study was conducted among a group of dental patients aged (6-8 years old) of both genders to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE) compared to traditional local anesthesia:
- Pain perception.
- Pain related behaviors.
- Dental anxiety
- Anesthetic efficiency.
- Patient acceptance and preference
Detailed description
The prevalent phobia of needles and the associated rise in dental anxiety when using the traditional needle method of LA infiltration, the development of needle-free alternatives for local anesthetics became an urgent necessity. The NumBee (BioDent, Simi Valley, CA) is a new gadget that promises less pain administration of local anesthetic without the use of a hypodermic needle. It is a tiny metal cannula with a silicone-like covering that is used for intraligmentary injection without penetrating the periodontal ligament. This study was performed due to the lack of sufficient research on NumBee and since it meets a number of exceptional criteria, including being able to anesthetize just one tooth without having to do so for the entire alveolar dental nerve and having a needleless design that may be more appealing to children than the distressing appearance of traditional dental syringes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional syringe | Active comparator | Device: Traditional dental syringeDental anesthesia delivered by a traditional syringe |
| NumBee | Experimental | Device: dental syringe ( NumBee)Dental anesthesia delivered by a novel needle-less syringe |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1. Mentally and medically compromised child. 2. Patient on medication that effect on the pain perception. 3. History of allergy to L.A.
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 |
|---|---|---|
| dental syringe ( NumBee)assess the capability of NumBee to reduce anxiety and pain during injection | Device | NumBee |
| Traditional dental syringecompare the level of anxiety of the traditional dental syringe and the Number dental syringe | Device | Traditional syringe |
Primary outcome
pain perception
Time frame: five months
checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment
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 12 Jun 2023.
- Individual participant dataSharing planned: Yes. it will be my pleasure to share and information with other resaercher
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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.
Duaa K Naji principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental syringe ( NumBee) and Traditional dental syringe in people with Dental Phobia and Dental Anxiety, run by Duaa Kamal Naji at 1 site in Iraq.
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 0 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 12 Jun 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 Iraq. 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 perception (time frame: five months). 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 12 Jun 2023.