Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe
1 other identifier
interventional
46
0 countries
N/A
Brief Summary
The study will be conducted to evaluate the effect of the vibration assisted syringe on pain perception and anxiety in children during intra oral injection of local anesthesia in comparison with conventional syringe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
February 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJanuary 2, 2020
December 1, 2019
12 months
December 26, 2019
December 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Pain rating scale
Visual linear analogue scale
baseline
Secondary Outcomes (1)
anxiety
baseline
Study Arms (2)
study group
ACTIVE COMPARATORGroup I (study group); children receiving intraoral injection of local anasethia using the vibration assisted syringe.
control group
ACTIVE COMPARATORGroup II (control group): children receiving intraoral injection of local anasethia using the standard syringe.
Interventions
VibraJect; is a small battery-operated attachment that snaps on to the standard dental syringe. It delivers a high-frequency vibration to the needle which is strong enough for the patient to feel.
Eligibility Criteria
You may qualify if:
- Cooperative patient. (rating 4 or 3 based on Frankl behavior scale).
- Children aging from 4 to 6 years
- Suffering from one or more deep carious lesions in their primary molars.
- Restorable primary molars
You may not qualify if:
- Medically compromised patients.
- Uncooperative children (rating 1 or 2 on the Frankl behavior scale) needing special line of treatment through general anesthesia.
- Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
- Presence of any radiographic signs of abscess, bone loss, internal or external root resorption.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
PMID: 21406147BACKGROUNDWilson S. Management of child patient behavior: quality of care, fear and anxiety, and the child patient. J Endod. 2013 Mar;39(3 Suppl):S73-7. doi: 10.1016/j.joen.2012.11.040.
PMID: 23439049BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mohamed abdallah
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dentist
Study Record Dates
First Submitted
December 26, 2019
First Posted
January 2, 2020
Study Start
February 8, 2020
Primary Completion
February 1, 2021
Study Completion
March 1, 2021
Last Updated
January 2, 2020
Record last verified: 2019-12