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)

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Dental Anxiety; Dental Phobia; Needle Phobia
• Intervention / Treatment: Device: Traditional dental syringe; Device: dental syringe ( NumBee)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • KHARkh
    • Baghdad, KHARkh, Iraq, 00964
      • University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional syringe; Dental anesthesia delivered by a traditional syringe	Device: Traditional dental syringe; compare the level of anxiety of the traditional dental syringe and the Number dental syringe
Experimental: NumBee; Dental anesthesia delivered by a novel needle-less syringe	Device: dental syringe ( NumBee); assess the capability of NumBee to reduce anxiety and pain during injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain perception	checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment	five months

Collaborators and Investigators

• Sponsor: Duaa Kamal Naji
• Investigators: Principal Investigator: Duaa K Naji, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Dental anxiety; Pain perception; Anesthetic efficiency
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: 576322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: it will be my pleasure to share and information with other resaercher
• IPD Sharing Time Frame: it will be available in 2023/2024 and for no limits

IPD Sharing Access Criteria

data will be sent in e-mail for anyone wishes to access.

Doaa.Kamal1202a@codental.uobaghdad.edu.iq

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No