Back to resultsAssessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe
Primary Purpose
Dental Phobia, Dental Anxiety, Anesthesia, Local
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
dental syringe ( NumBee)
Traditional dental syringe
Sponsored by
About this trial
This is an interventional device feasibility trial for Dental Phobia focused on measuring Dental anxiety, Pain perception, Anesthetic efficiency
Eligibility Criteria
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.
Sites / Locations
- University of Baghdad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional syringe
NumBee
Arm Description
Dental anesthesia delivered by a traditional syringe
Dental anesthesia delivered by a novel needle-less syringe
Outcomes
Primary Outcome Measures
pain perception
checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05899296
Brief Title
Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe
Official Title
Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Duaa Kamal Naji
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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:
Pain perception.
Pain related behaviors.
Dental anxiety
Anesthetic efficiency.
Patient acceptance and preference
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Phobia, Dental Anxiety, Anesthesia, Local, Needle Phobia
Keywords
Dental anxiety, Pain perception, Anesthetic efficiency
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional syringe
Arm Type
Active Comparator
Arm Description
Dental anesthesia delivered by a traditional syringe
Arm Title
NumBee
Arm Type
Experimental
Arm Description
Dental anesthesia delivered by a novel needle-less syringe
Intervention Type
Device
Intervention Name(s)
dental syringe ( NumBee)
Intervention Description
assess the capability of NumBee to reduce anxiety and pain during injection
Intervention Type
Device
Intervention Name(s)
Traditional dental syringe
Intervention Description
compare the level of anxiety of the traditional dental syringe and the Number dental syringe
Primary Outcome Measure Information:
Title
pain perception
Description
checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment
Time Frame
five months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duaa K Naji
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Baghdad
City
Baghdad
State/Province
KHARkh
ZIP/Postal Code
00964
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe
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