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
• Status: Completed
• Phase: N/A
• 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
• 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.

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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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Anxiety Disorders
• Dental Anxiety
• Dental Phobia
• Needle Phobia
• Phobic Disorders

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