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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Dentistry Local Anesthesia Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Group

The children anesthesia will be traditional technique

Group Type ACTIVE_COMPARATOR

Local anesthesia with traditional technique

Intervention Type 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

Topic anesthesia

Intervention Type DRUG

Application of topical anesthetic for 60 seconds with benzocaine

Local anesthetic

Intervention Type DRUG

2% lidocaine with epinephrine 1: 100000 1.8 mL

Computerized Group

The children anesthesia will be computerized technique

Group Type ACTIVE_COMPARATOR

Local anesthesia with computerized technique

Intervention Type 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

Topic anesthesia

Intervention Type DRUG

Application of topical anesthetic for 60 seconds with benzocaine

Local anesthetic

Intervention Type DRUG

2% lidocaine with epinephrine 1: 100000 1.8 mL

DentalVibe Group

The children anesthesia will be DentalVibe technique

Group Type ACTIVE_COMPARATOR

Local anesthesia with DentalVibe technique

Intervention Type 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

Topic anesthesia

Intervention Type DRUG

Application of topical anesthetic for 60 seconds with benzocaine

Local anesthetic

Intervention Type DRUG

2% lidocaine with epinephrine 1: 100000 1.8 mL

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Topic anesthesia

Application of topical anesthetic for 60 seconds with benzocaine

Intervention Type DRUG

Local anesthetic

2% lidocaine with epinephrine 1: 100000 1.8 mL

Intervention Type DRUG

Other Intervention Names

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Traditional anesthesia Conventional anesthesia Computerized anesthesia DentalVibe anesthesia Topical anesthesia Anesthetic

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes