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

NCT05899296 | Completed

• 1 other identifier: 576322
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Pain perception.
2. 2.Pain related behaviors.
3. 3.Dental anxiety
4. 4.Anesthetic efficiency.
5. 5.Patient acceptance and preference

Conditions

Dental Phobia; Dental Anxiety; Anesthesia, Local; Needle Phobia

Keywords

Dental anxiety; Pain perception; Anesthetic efficiency

Outcome Measures

Primary Outcomes (1)

• pain perception

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

  five months

Study Arms (2)

Traditional syringe

ACTIVE COMPARATOR

Dental anesthesia delivered by a traditional syringe

Device: Traditional dental syringe

NumBee

EXPERIMENTAL

Dental anesthesia delivered by a novel needle-less syringe

Device: dental syringe ( NumBee)

Interventions

dental syringe ( NumBee) DEVICE

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

NumBee

Traditional dental syringe DEVICE

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

Traditional syringe

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Mentally and medically compromised child. 2. Patient on medication that effect on the pain perception. 3. History of allergy to L.A.

Sponsors & Collaborators

• Duaa Kamal Naji: lead

Study Sites (1)

University of Baghdad

Baghdad, KHARkh, 00964, Iraq

Location

Study Officials

• Duaa K Naji

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bachelor of dental surgery

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 12, 2023
• Study Start: March 15, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 30, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: it will be available in 2023/2024 and for no limits
• Access Criteria: data will be sent in e-mail for anyone wishes to access. Doaa.Kamal1202a@codental.uobaghdad.edu.iq

Locations

IR (1)