NCT03033628

Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children

Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using "DentalVibe Comfort System" Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Years – 7 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.

Detailed description

The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone. Intervention: History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria. Clinical procedure: Intervention group: Clinical examination using mirror and probe to assess inclusion criteria. Before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec. Demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally. The cheek will be retracted and the device will be turned on. 1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min. Control group: AS that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off. Assessment: Objective assessment will be performed by observing the patients behavior using the FLAAC scale during the anesthetic injection and needle insertion. Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.

Conditions

• Dental Anxiety

Interventions

Type	Name	Description
DEVICE	injection using DentalVibe comfort system	giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
DEVICE	traditional dental injection	giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-06-01
• Completion: 2018-01-01
• First posted: 2017-01-27
• Last updated: 2017-02-15

Regulatory

• FDA-regulated device study