NCT03953001

Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children

Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Imam Abdulrahman Bin Faisal University · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.

Detailed description

Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.

Conditions

• Local Anaesthetic
• Dental Anxiety

Interventions

Type	Name	Description
DEVICE	Adminstration Technique using Buzzy external distractor	External application of Buzzy distractor during administration of dental anesthetic
DRUG	2% Lidocaine with 1:50,000 epinephrine	Local Dental anesthetic infiltration
DRUG	Topical Anesthetic	20% Benzocaine gel was applied on the area of infiltration

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-04-01
• Completion: 2018-06-01
• First posted: 2019-05-16
• Last updated: 2019-05-16

Locations

1 site across 1 country: Saudi Arabia