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Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe

Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05899296
Enrollment
30
Registered
2023-06-12
Start date
2022-03-15
Completion date
2022-08-30
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Dental Anxiety, Dental Phobia, Needle Phobia

Keywords

Dental anxiety, Pain perception, Anesthetic efficiency

Brief 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. 5. 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.

Interventions

DEVICEdental syringe ( NumBee)

assess the capability of NumBee to reduce anxiety and pain during injection

compare the level of anxiety of the traditional dental syringe and the Number dental syringe

Sponsors

Duaa Kamal Naji
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients with American Society of Anesthesiologists-1(ASA 1) health status (A completely healthy fit patient). 2\. Not mentally retarded patient. 3. Cooperative patient, as determined by a behavioral rating of positive or definitely positive according to the Frankle behavior classification scale. 4\. Without a history of dental visits. \-

Exclusion criteria

* 1\. Mentally and medically compromised child. 2. Patient on medication that effect on the pain perception. 3. History of allergy to L.A.

Design outcomes

Primary

MeasureTime frameDescription
pain perceptionfive monthschecking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026