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

Anxiety, Dental Clinical Trial

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 (

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04215055
• Other study ID #: Vibraject in Dentistry
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 8, 2020
• Est. completion date: March 2021

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: mohamed abdallah
• Phone: 01122083204
• Email: mohamedabdallah549[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Dental

Intervention

Device:
• vibraject
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain rating scale	Visual linear analogue scale	baseline
Secondary	anxiety	Visual facial anxiety scale	baseline