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

September 9, 2019 updated by: Ra'ed Salma, Riyadh Colleges of Dentistry and Pharmacy

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12734
        • Riyadh Elm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain of buccal injection with DentalVibe®
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.
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
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Other Names:
  • Xylocaine 2% with Epinephrine
Active Comparator: Pain of buccal injection without DentalVibe®
Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
Drug: Lidocaine Epinephrine
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Other Names:
  • Xylocaine 2% with Epinephrine
Experimental: Pain of palatal injection with DentalVibe®
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.
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
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Other Names:
  • Xylocaine 2% with Epinephrine
Active Comparator: Pain of palatal injection without DentalVibe®
Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
Drug: Lidocaine Epinephrine
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Other Names:
  • Xylocaine 2% with Epinephrine
Experimental: Pain of block injection with DentalVibe®
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.
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
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Other Names:
  • Xylocaine 2% with Epinephrine
Active Comparator: Pain of block injection without DentalVibe®
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.
Drug: Lidocaine Epinephrine
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Other Names:
  • Xylocaine 2% with Epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of needle penetration of buccal LA injection
Time Frame: 1-2 seconds after mucosal penetration
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
Pain of anesthesia delivery during buccal LA infiltration
Time Frame: 30 seconds after LA solution delivery
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
Pain of needle penetration of palatal LA injection
Time Frame: 1-2 seconds after mucosal penetration
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
Pain of anesthesia delivery during palatal LA infiltration
Time Frame: 30 seconds after LA solution delivery
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
Pain of needle penetration of IAN block LA injection
Time Frame: 1-2 seconds after mucosal penetration
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
Pain of anesthesia delivery during IAN block LA injection
Time Frame: 30 seconds after LA solution delivery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

Investigators

  • Principal Investigator: Ra'ed G Salma, Riyadh Elm University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

September 5, 2019

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

February 10, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRP/2018/286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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