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

NCT03176446 — Not applicable, Completed, 210 participants, Universidade Estadual de Ponta Grossa

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Registry	NCT03176446
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, device feasibility
Enrollment	210 (Actual)
Sponsor	Universidade Estadual de Ponta Grossa (Other)
Conditions	Pediatric Dentistry, Local Anesthesia, Pain Management
Interventions	Local anesthesia with traditional technique, Local anesthesia with computerized technique, Local anesthesia with DentalVibe technique, Topic anesthesia, Local anesthetic (Device, drug)
Dates	start 2017-10-01, primary completion 2018-11-30, completion 2019-03-01, first posted 2017-06-05, last updated 2020-04-30
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control Group	Active comparator	Device: Local anesthesia with traditional technique; Drug: Topic anesthesia; Drug: Local anesthetic	The children anesthesia will be traditional technique
Computerized Group	Active comparator	Device: Local anesthesia with computerized technique; Drug: Topic anesthesia; Drug: Local anesthetic	The children anesthesia will be computerized technique
DentalVibe Group	Active comparator	Device: Local anesthesia with DentalVibe technique; Drug: Topic anesthesia; Drug: Local anesthetic	The children anesthesia will be DentalVibe technique

Local anesthesia with traditional technique (Device), also known as Traditional anesthesia, Conventional anesthesia: 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
Local anesthesia with computerized technique (Device), also known as Computerized anesthesia: 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
Local anesthesia with DentalVibe technique (Device), also known as DentalVibe anesthesia: 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 (Drug), also known as Topical anesthesia: Application of topical anesthetic for 60 seconds with benzocaine
Local anesthetic (Drug), also known as Anesthetic: 2% lidocaine with epinephrine 1: 100000 1.8 mL

+Outcome measures

Primary outcomes

Self-perception of pain [Immediately after anesthesia]: The pain will be analyzed by the Wong Baker Faces scales
Pain Behavior [During the anesthetic procedure]: The pain will be analyzed by the FLACC
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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 5 Years to 12 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Ponta Grossa State University	Ponta Grossa, Paraná	Brazil

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