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

Study Overview
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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.

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

Conditions
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Pediatric Dentistry, Local Anesthesia, Pain Management

Intervention / Treatment
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* Device: Local anesthesia with traditional technique
* Device: Local anesthesia with computerized technique
* Device: Local anesthesia with DentalVibe technique
* Drug: Topic anesthesia
* Drug: Local anesthetic


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>The children anesthesia will be traditional technique | Device: Local anesthesia with traditional technique<br>* 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<br>* Other names: Conventional anesthesia;Drug: Topic anesthesia<br>* Application of topical anesthetic for 60 seconds with benzocaine<br>* Other names: Topical anesthesia;Drug: Local anesthetic<br>* 2% lidocaine with epinephrine 1: 100000 1.8 mL<br>* Other names: Anesthetic;|
| Active Comparator: Computerized Group<br>The children anesthesia will be computerized technique | Device: Local anesthesia with computerized technique<br>* 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<br>* Other names: Computerized anesthesia;Drug: Topic anesthesia<br>* Application of topical anesthetic for 60 seconds with benzocaine<br>* Other names: Topical anesthesia;Drug: Local anesthetic<br>* 2% lidocaine with epinephrine 1: 100000 1.8 mL<br>* Other names: Anesthetic;|
| Active Comparator: DentalVibe Group<br>The children anesthesia will be DentalVibe technique | Device: Local anesthesia with DentalVibe technique<br>* 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<br>* Other names: DentalVibe anesthesia;Drug: Topic anesthesia<br>* Application of topical anesthetic for 60 seconds with benzocaine<br>* Other names: Topical anesthesia;Drug: Local anesthetic<br>* 2% lidocaine with epinephrine 1: 100000 1.8 mL<br>* Other names: Anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCARED Questionnaire | Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire | Before anesthesia | 
| Corah Questionnaire | Children will be evaluated for the dentistry anxiety prior to any anesthesia | Before anethesia | 
| VPT modified | Children will be evaluated for the anxiety after to any anesthesia | Before anethesia and immediately after anesthesia | 
| Blood pressure | The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of blood pressure | Immediately before anesthesia, during anesthesia | 
| Respiratory rate | The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate | Immediately before anesthesia, during anesthesia | 
| Heart rate | The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate | Immediately before anesthesia, during anesthesia | 
| Oxygen saturation | The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation | Immediately before anesthesia, during anesthesia | 
| Salivary cortisol | The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol | Immediately before anesthesia, during anesthesia |