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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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 (

Conditions
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Anxiety, Dental

Intervention / Treatment
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* Device: vibraject


Participation Criteria
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Eligibility Criteria
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inclusion criteria 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 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>Group I (study group); children receiving intraoral injection of local anasethia using the vibration assisted syringe. | Device: vibraject<br>* 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.<br>|
| Active Comparator: control group<br>Group II (control group): children receiving intraoral injection of local anasethia using the standard syringe. | Device: vibraject<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rating scale | Visual linear analogue scale | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety | Visual facial anxiety scale | baseline |