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CompletedNCT05899296Updated Jun 12, 2023

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

An interventional study of dental syringe ( NumBee) and Traditional dental syringe in Dental Phobia, Dental Anxiety and Anesthesia, Local, sponsored by Duaa Kamal Naji. Completed at 1 site in Iraq. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by Duaa Kamal Naji · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

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

Keywords

  • Dental anxiety
  • Pain perception
  • Anesthetic efficiency
03

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
  1. 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.
04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Traditional syringe

    Dental anesthesia delivered by a traditional syringe

    Device: Traditional dental syringe

  • Experimental
    NumBee

    Dental anesthesia delivered by a novel needle-less syringe

    Device: dental syringe ( NumBee)

Interventions

  • Devicedental syringe ( NumBee)

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

  • DeviceTraditional dental syringe

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

05

What researchers measure

Primary outcomes

  1. pain perception

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

    Time frame: five months

06

Study locations

1 site
  • University of Baghdad
    Baghdad, KHARkh 00964, Iraq
07

References and documents

Individual participant data

Plan to share: Yes — it will be my pleasure to share and information with other resaercher

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05899296
Lead sponsor
Duaa Kamal Naji
Responsible party
Duaa Kamal Naji (Bachelor of dental surgery, University of Baghdad) — Sponsor-investigator
First posted
Jun 12, 2023
Start date
Mar 15, 2022
Primary completion
Aug 1, 2022
Completion
Aug 30, 2022
Last update
Jun 12, 2023

Study contacts

Duaa K Naji
principal investigator · University of Baghdad

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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