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

Riyadh Colleges of Dentistry and Pharmacy

Status: Completed

Conditions: Anesthetics, Local

Treatments: Drug: Lidocaine Epinephrine; Device: DentalVibe® Comfort Injection System

Study type: Interventional

Funder types: Other

Identifiers

NCT03839134

FRP/2018/286

Details and patient eligibility

About

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).

Enrollment: 166 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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166 participants in 6 patient groups

Pain of buccal injection with DentalVibe®

Experimental group

Description:

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.

Treatment:

Device: DentalVibe® Comfort Injection System

Drug: Lidocaine Epinephrine

Pain of buccal injection without DentalVibe®

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine Epinephrine

Pain of palatal injection with DentalVibe®

Experimental group

Description:

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.

Treatment:

Device: DentalVibe® Comfort Injection System

Drug: Lidocaine Epinephrine

Pain of palatal injection without DentalVibe®

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine Epinephrine

Pain of block injection with DentalVibe®

Experimental group

Description:

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.

Treatment:

Device: DentalVibe® Comfort Injection System

Drug: Lidocaine Epinephrine

Pain of block injection without DentalVibe®

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine Epinephrine