Clinical trial NCT04215055: Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe
Official title: 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 (
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain rating scale
timeFrame: baseline
Secondary outcomes:
measure: anxiety
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: mohamed abdallah
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
citation: Wilson S. Management of child patient behavior: quality of care, fear and anxiety, and the child patient. J Endod. 2013 Mar;39(3 Suppl):S73-7. doi: 10.1016/j.joen.2012.11.040.