NCT03839134

The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients

The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Riyadh Colleges of Dentistry and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).

Conditions

• Anesthetics, Local

Interventions

Type	Name	Description
DEVICE	DentalVibe® Comfort Injection System	Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.
DRUG	Lidocaine Epinephrine	Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).

Timeline

• Start date: 2019-03-20
• Primary completion: 2019-08-01
• Completion: 2019-09-05
• First posted: 2019-02-15
• Last updated: 2019-09-10

Locations

1 site across 1 country: Saudi Arabia