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

NCT03176446 | Completed

• 1 other identifier: 64773417.3.0000.5689
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Dentistry; Local Anesthesia; Pain Management

Outcome Measures

Primary Outcomes (3)

• Self-perception of pain

  The pain will be analyzed by the Wong Baker Faces scales

  Immediately after anesthesia

• Pain Behavior

  The pain will be analyzed by the FLACC

  During the anesthetic procedure

• Self-perception of pain

  The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain

  Immediately after anesthesia

Secondary Outcomes (8)

• SCARED Questionnaire

  Before anesthesia

• Corah Questionnaire

  Before anethesia

• VPT modified

  Before anethesia and immediately after anesthesia

• Blood pressure

  Immediately before anesthesia, during anesthesia

• Respiratory rate

  Immediately before anesthesia, during anesthesia

Study Arms (3)

Control Group

ACTIVE COMPARATOR

The children anesthesia will be traditional technique

Device: Local anesthesia with traditional technique; Drug: Topic anesthesia; Drug: Local anesthetic

Computerized Group

ACTIVE COMPARATOR

The children anesthesia will be computerized technique

Device: Local anesthesia with computerized technique; Drug: Topic anesthesia; Drug: Local anesthetic

DentalVibe Group

ACTIVE COMPARATOR

The children anesthesia will be DentalVibe technique

Device: Local anesthesia with DentalVibe technique; Drug: Topic anesthesia; Drug: Local anesthetic

Interventions

Local anesthesia with traditional technique DEVICE

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

Also known as: Traditional anesthesia, Conventional anesthesia

Control Group

Local anesthesia with computerized technique DEVICE

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

Also known as: Computerized anesthesia

Computerized Group

Local anesthesia with DentalVibe technique DEVICE

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

Also known as: DentalVibe anesthesia

DentalVibe Group

Topic anesthesia DRUG

Application of topical anesthetic for 60 seconds with benzocaine

Also known as: Topical anesthesia

Computerized Group; Control Group; DentalVibe Group

Local anesthetic DRUG

2% lidocaine with epinephrine 1: 100000 1.8 mL

Also known as: Anesthetic

Computerized Group; Control Group; DentalVibe Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual de Ponta Grossa: lead

Study Sites (1)

Ponta Grossa State University

Ponta Grossa, Paraná, 84030900, Brazil

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local; Anesthesia; Anesthetics, Local; Anesthetics

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia and Analgesia; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: The total sample is divided into two subgroups, with 105 children aged 5 to 8 years and 105 children aged 9 to 12 years. The analysis is more sensitive and specific to each subgroup. The results of each subgroup will be analyzed in isolation and give rise to two different papers.

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: June 5, 2017
• Study Start: October 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: March 1, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)