NCT03790540

Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients

Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients: A Randomized Controlled Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nourhan M.Aly · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain reduction during local anesthetic injection compared to traditional injection without aid of DentalVibe in pediatric patients.

Detailed description

This study is a crossover randomized controlled clinical trial where (N=60 ) children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. These children will be selected based on a need for local anesthesia for pulpotomy treatment on both sides of the mandible. All selected children will be randomly allocated into 2 groups. Group I (assigned to injection with the aid of DentalVibe tool), Group II(assigned to conventional injection). Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period. Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment . Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DEVICE	DentalVibe	It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients
DRUG	Topical Benzocaine 20%	Topical benzocaine 20% gel on the mucosal injection site prior to injection

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-03-10
• Completion: 2019-05-15
• First posted: 2018-12-31
• Last updated: 2020-04-10

Locations

1 site across 1 country: Egypt