Trial | NCT03839134  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    166
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).
Study Started
Mar 20
2019
Primary Completion
Aug 01
2019
Study Completion
Sep 05
2019
Last Update
Sep 10
2019

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.

  • Other names: DentalVibe

Drug Lidocaine Epinephrine [epinephrine (levophed), lidocaine (xylocaine)]

Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).

  • Other names: Xylocaine 2% with Epinephrine

Pain of buccal injection with DentalVibe® Experimental

DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.

Pain of buccal injection without DentalVibe® Active Comparator

Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.

Pain of palatal injection with DentalVibe® Experimental

DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.

Pain of palatal injection without DentalVibe® Active Comparator

Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.

Pain of block injection with DentalVibe® Experimental

DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection.

Pain of block injection without DentalVibe® Active Comparator

Local anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.

Criteria 

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status class I
Planned for multiple dental treatments in the maxilla and mandible bilaterally

Exclusion Criteria:

Patients <18 years old
Pregnant ladies
Smokers and alcoholics
Patients on medications
Drug abusers
Never received dental treatment under local anesthesia before
Patients with an acute infection with or without fever
Patients with preoperative pain
No Results Posted