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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riyadh Colleges of Dentistry and Pharmacy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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