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

Study Overview
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Brief Summary
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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: Pain perception. Pain related behaviors. Dental anxiety Anesthetic efficiency. Patient acceptance and preference

Detailed Description
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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.

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

Conditions
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Dental Phobia, Dental Anxiety, Anesthesia, Local, Needle Phobia

Intervention / Treatment
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* Device: dental syringe ( NumBee)
* Device: Traditional dental syringe


Participation Criteria
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Eligibility Criteria
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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. - 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain perception, Anesthetic efficiency, Dental anxiety