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Clinical Trials/NCT04215055
NCT04215055
Unknown
N/A

Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe in Decreasing Children Pain and Anxiety Perception During Local Anesthetic Injection ) Randomized Controlled Clinical Trial (

Cairo University0 sites46 target enrollmentFebruary 8, 2020
ConditionsAnxiety, Dental

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety, Dental
Sponsor
Cairo University
Enrollment
46
Primary Endpoint
Pain rating scale
Last Updated
6 years ago

Overview

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.

Detailed Description

As for granted the main concern in pediatric dentistry is to guarantee a positive response from child for any further appointments, that's why we aim to manage a successful dental procedure keeping a stress free situation. Conventional local anesthetic technique is the most commonly used technique for anesthetizing teeth but in turn it has shown the highest levels of discomfort in comparison with other techniques. VibraJect is vibration associated syringe device, it is simple and cost effective solution to alleviate injection discomfort. It works because the light pressure of a Vibraject injection is carried rapidly to the brain by thicker insulated nerve tissues. In contrast, the needle prick travels on thinner nerve tissues, arriving too late for the brain to register the sensation. Vibraject is good news for the patient, because the anesthetic itself causes virtually no discomfort and good news for the dentist, who can work easily knowing that patient, is comfortable.

Registry
clinicaltrials.gov
Start Date
February 8, 2020
End Date
March 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Abdallah Mohamed Abdallah

dentist

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pain rating scale

Time Frame: baseline

Visual linear analogue scale

Secondary Outcomes

  • anxiety(baseline)

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