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OpenTrials
Completed

NCT Number: NCT05899296

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

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

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Key information

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Baghdad

Baghdad, KHARkh, 00964, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • 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.

Treatment and study plan

dental syringe ( NumBee)

Device

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

Traditional dental syringe

Device

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

Primary outcomes

  1. pain perception

    Time frame: five months

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

Sponsors and collaborators

Lead sponsor

Duaa Kamal Naji

Other

Registry information

Official study title

Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2023
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.