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

NCT ID: NCT05899296

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-08-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Traditional syringe

Dental anesthesia delivered by a traditional syringe

Group Type: ACTIVE_COMPARATOR

Traditional dental syringe

Intervention Type: DEVICE

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

NumBee

Dental anesthesia delivered by a novel needle-less syringe

Group Type: EXPERIMENTAL

dental syringe ( NumBee)

Intervention Type: DEVICE

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

Interventions

dental syringe ( NumBee)

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

Intervention Type: DEVICE

Traditional dental syringe

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duaa Kamal Naji

OTHER

Sponsor Role: lead

Responsible Party

Duaa Kamal Naji

Bachelor of dental surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Duaa K Naji

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

University of Baghdad

Baghdad, KHARkh, Iraq

Countries

Iraq

Other Identifiers

576322

Identifier Type: -

Identifier Source: org_study_id