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

Sponsor
Duaa Kamal Naji (Other)
Overall Status
Completed
CT.gov ID
NCT05899296
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
5.5
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: dental syringe ( NumBee)
  • Device: Traditional dental syringe
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Device Feasibility
Official Title:
Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)
Actual Study Start Date :
Mar 15, 2022
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Aug 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pain perception [five months]

    checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria:1. Patients with American Society of Anesthesiologists-1(ASA 1) health status (A completely healthy fit patient).

  1. 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.

  2. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Baghdad Baghdad KHARkh Iraq 00964

Sponsors and Collaborators

  • Duaa Kamal Naji

Investigators

  • Principal Investigator: Duaa K Naji, University of Baghdad

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duaa Kamal Naji, Bachelor of dental surgery, University of Baghdad
ClinicalTrials.gov Identifier:
NCT05899296
Other Study ID Numbers:
  • 576322
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duaa Kamal Naji, Bachelor of dental surgery, University of Baghdad
Dental anxiety
Pain perception
Anesthetic efficiency
Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders

Study Results

No Results Posted as of Jun 12, 2023