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NCT05899296 Clinical Trial

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

Anesthesia, Local Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05899296
Other study ID # 576322
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date August 30, 2022

Study information
Verified date June 2023
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 5. Patient acceptance and preference

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 30, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• dental syringe ( NumBee)
assess the capability of NumBee to reduce anxiety and pain during injection
• Traditional dental syringe
compare the level of anxiety of the traditional dental syringe and the Number dental syringe

Locations
Country Name City State
Iraq University of Baghdad Baghdad KHARkh

Sponsors (1)
Lead Sponsor Collaborator
Duaa Kamal Naji

Country where clinical trial is conducted

Iraq, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain perception checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment five months
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