NCT03839134 - The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

166

Conditions

Anesthetics, Local

Interventions

DentalVibe® Comfort Injection SystemDEVICE

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.

Lidocaine EpinephrineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Riyadh Elm University

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Pain of needle penetration of buccal LA injection

The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.

Time frame: 1-2 seconds after mucosal penetration

Pain of anesthesia delivery during buccal LA infiltration

The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.

Time frame: 30 seconds after LA solution delivery

Pain of needle penetration of palatal LA injection

The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.

Time frame: 1-2 seconds after mucosal penetration

Pain of anesthesia delivery during palatal LA infiltration

The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.

Time frame: 30 seconds after LA solution delivery

Pain of needle penetration of IAN block LA injection

The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.

Time frame: 1-2 seconds after mucosal penetration

Pain of anesthesia delivery during IAN block LA injection

The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.