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

Duaa Kamal Naji

Status: Completed

Conditions: Needle Phobia; Dental Anxiety; Anesthesia, Local; Dental Phobia

Treatments: Device: Traditional dental syringe; Device: dental syringe ( NumBee)

Study type: Interventional

Funder types: Other

Identifiers

NCT05899296

576322

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

3. 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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Traditional syringe

Active Comparator group

Description:

Dental anesthesia delivered by a traditional syringe

Treatment:

Device: Traditional dental syringe

NumBee

Experimental group

Description:

Dental anesthesia delivered by a novel needle-less syringe

Treatment:

Device: dental syringe ( NumBee)