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Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe

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 (

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04215055
Enrollment
46
Registered
2020-01-02
Start date
2020-02-08
Completion date
2021-03-31
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Dental

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.

Interventions

DEVICEvibraject

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

1. Cooperative patient. (rating 4 or 3 based on Frankl behavior scale). 2. Children aging from 4 to 6 years 3. Suffering from one or more deep carious lesions in their primary molars. 4. Restorable primary molars

Exclusion criteria

1. Medically compromised patients. 2. Uncooperative children (rating 1 or 2 on the Frankl behavior scale) needing special line of treatment through general anesthesia. 3. Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess. 4. Presence of any radiographic signs of abscess, bone loss, internal or external root resorption.

Design outcomes

Primary

MeasureTime frameDescription
Pain rating scalebaselineVisual linear analogue scale

Secondary

MeasureTime frameDescription
anxietybaselineVisual facial anxiety scale

Contacts

Primary Contactmohamed abdallah
mohamedabdallah549@gmail.com01122083204

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026