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

Not Applicable

Completed

• Conditions: Local Anesthesia; Pediatric Dentistry; Pain Management
• Interventions: Device: Local anesthesia with DentalVibe technique; Device: Local anesthesia with traditional technique; Device: Local anesthesia with computerized technique; Drug: Topic anesthesia; Drug: Local anesthetic

• Registration Number: NCT03176446
• Lead Sponsor: Universidade Estadual de Ponta Grossa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2017-10-01
• Primary Completion: 2018-11-30
• Study Completion: 2019-03-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized Group	Topic anesthesia	The children anesthesia will be computerized technique
DentalVibe Group	Local anesthesia with DentalVibe technique	The children anesthesia will be DentalVibe technique
DentalVibe Group	Topic anesthesia	The children anesthesia will be DentalVibe technique
Control Group	Local anesthesia with traditional technique	The children anesthesia will be traditional technique
Control Group	Topic anesthesia	The children anesthesia will be traditional technique
Control Group	Local anesthetic	The children anesthesia will be traditional technique
Computerized Group	Local anesthesia with computerized technique	The children anesthesia will be computerized technique
Computerized Group	Local anesthetic	The children anesthesia will be computerized technique
DentalVibe Group	Local anesthetic	The children anesthesia will be DentalVibe technique

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ponta Grossa State University; 🇧🇷 Ponta Grossa, Paraná, Brazil