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

Cairo University (CU)

Status: Unknown

Conditions: Anxiety, Dental

Treatments: Device: vibraject

Study type: Interventional

Funder types: Other

Identifiers

NCT04215055

Vibraject in Dentistry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

study group

Active Comparator group

Description:

Group I (study group); children receiving intraoral injection of local anasethia using the vibration assisted syringe.

Treatment:

Device: vibraject

control group

Active Comparator group

Description:

Group II (control group): children receiving intraoral injection of local anasethia using the standard syringe.

Treatment:

Device: vibraject