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

Not Applicable

• Conditions: Anxiety, Dental
• Interventions: Device: vibraject

• Registration Number: NCT04215055
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-26
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Study Start: 2020-02-08
• Primary Completion: 2021-02
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	vibraject	Group I (study group); children receiving intraoral injection of local anasethia using the vibration assisted syringe.
control group	vibraject	Group II (control group): children receiving intraoral injection of local anasethia using the standard syringe.

Primary Outcome Measures

Name	Time	Method
Pain rating scale	baseline	Visual linear analogue scale

Secondary Outcome Measures

Name	Time	Method
anxiety	baseline	Visual facial anxiety scale