Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment

April 28, 2020 updated by: Priscila de Camargo Smolarek, Universidade Estadual de Ponta Grossa
Fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in childhood, through experience misconduct. The objective of this study is to evaluate the pain and anxiety related to 4 different modalities of anesthesia in children. Will be selected volunteers aged between 5 and 12 years who need restorative dental treatment in posterior teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia: conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological and behavioral criteria. For the physiological evaluation will be measured the blood pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong Baker Faces. The results will be submitted to parametric and non-parametric statistical analysis, according to the data obtained in the different evaluation criteria.

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.
210

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

  • Brazil
    • Paraná
      • Ponta Grossa, Paraná, Brazil, 84030900
        • Ponta Grossa State 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

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla.

Exclusion Criteria:

  • The person responsible does not authorize the participation of the child as a research volunteer.
  • Be using pain modulating drugs.
  • Be using anxiety modulating drugs.
  • Patients with a history of hypersensitivity to local anesthetics.
  • Patients with a history of systemic diseases.

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: DEVICE_FEASIBILITY
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

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.
ACTIVE_COMPARATOR: Control Group
The children anesthesia will be traditional technique
Device: Local anesthesia with traditional technique
Puncture with short needle in the region of the apical third of the tooth to be anesthetized Injection of local anesthetic, with speed 1ml / min
Other Names:
  • Conventional anesthesia
  • Traditional anesthesia
Drug: Topic anesthesia
Application of topical anesthetic for 60 seconds with benzocaine
Other Names:
  • Topical anesthesia
Drug: Local anesthetic
2% lidocaine with epinephrine 1: 100000 1.8 mL
Other Names:
  • Anesthetic
ACTIVE_COMPARATOR: Computerized Group
The children anesthesia will be computerized technique
Drug: Topic anesthesia
Application of topical anesthetic for 60 seconds with benzocaine
Other Names:
  • Topical anesthesia
Drug: Local anesthetic
2% lidocaine with epinephrine 1: 100000 1.8 mL
Other Names:
  • Anesthetic
Device: Local anesthesia with computerized technique
Puncture with short needle in the region of the apical third of the tooth to be anesthetized according to the recommendations of the manufacturer Injection of local anesthetic with computerized anesthesia equipment, with speed 0.5 ml / min
Other Names:
  • Computerized anesthesia
ACTIVE_COMPARATOR: DentalVibe Group
The children anesthesia will be DentalVibe technique
Drug: Topic anesthesia
Application of topical anesthetic for 60 seconds with benzocaine
Other Names:
  • Topical anesthesia
Drug: Local anesthetic
2% lidocaine with epinephrine 1: 100000 1.8 mL
Other Names:
  • Anesthetic
Device: Local anesthesia with DentalVibe technique
Use of DentalVibe in the apical region of the tooth to be anesthetized according to the manufacturer's guidelines Puncture with short needle enters the tips of the DentalVibe Injection of local anesthetic with traditional carpule, with speed 1 ml / min
Other Names:
  • DentalVibe anesthesia

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
Self-perception of pain
Time Frame: Immediately after anesthesia
The pain will be analyzed by the Wong Baker Faces scales
Immediately after anesthesia
Pain Behavior
Time Frame: During the anesthetic procedure
The pain will be analyzed by the FLACC
During the anesthetic procedure
Self-perception of pain
Time Frame: Immediately after anesthesia
The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain
Immediately after anesthesia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SCARED Questionnaire
Time Frame: Before anesthesia
Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire
Before anesthesia
Corah Questionnaire
Time Frame: Before anethesia
Children will be evaluated for the dentistry anxiety prior to any anesthesia
Before anethesia
VPT modified
Time Frame: Before anethesia and immediately after anesthesia
Children will be evaluated for the anxiety after to any anesthesia
Before anethesia and immediately after anesthesia
Blood pressure
Time Frame: Immediately before anesthesia, during anesthesia
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of blood pressure
Immediately before anesthesia, during anesthesia
Respiratory rate
Time Frame: Immediately before anesthesia, during anesthesia
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate
Immediately before anesthesia, during anesthesia
Heart rate
Time Frame: Immediately before anesthesia, during anesthesia
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate
Immediately before anesthesia, during anesthesia
Oxygen saturation
Time Frame: Immediately before anesthesia, during anesthesia
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation
Immediately before anesthesia, during anesthesia
Salivary cortisol
Time Frame: Immediately before anesthesia, during anesthesia
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol
Immediately before anesthesia, during anesthesia

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.
Universidade Estadual de Ponta Grossa

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.
October 1, 2017

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.
November 30, 2018

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.
March 1, 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).
May 12, 2017

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.
June 1, 2017

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.
June 5, 2017

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.
April 30, 2020

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.
April 28, 2020

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.
April 1, 2020

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.
  • 64773417.3.0000.5689

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Approval of the ethics committee
    Information identifier: 1.941.369

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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