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

Anesthetics, Local Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839134
• Other study ID #: FRP/2018/286
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: September 5, 2019

Study information

• Verified date: September 2019
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 5, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthetics, Local

Intervention

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.

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

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Elm University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-2 seconds after mucosal penetration
Primary	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.	30 seconds after LA solution delivery
Primary	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.	1-2 seconds after mucosal penetration
Primary	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.	30 seconds after LA solution delivery
Primary	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.	1-2 seconds after mucosal penetration
Primary	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.	30 seconds after LA solution delivery