Skip to main content
OpenTrials
Completed

NCT Number: NCT03176446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ponta Grossa State University

Ponta Grossa, Paraná, 84030900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Traditional anesthesia, Conventional anesthesia

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

Other names: Computerized anesthesia

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

Other names: DentalVibe anesthesia

Topic anesthesia

Drug

Application of topical anesthetic for 60 seconds with benzocaine

Other names: Topical anesthesia

Local anesthetic

Drug

2% lidocaine with epinephrine 1: 100000 1.8 mL

Other names: Anesthetic

Primary outcomes

  1. Self-perception of pain

    Time frame: Immediately after anesthesia

    The pain will be analyzed by the Wong Baker Faces scales

  2. Pain Behavior

    Time frame: During the anesthetic procedure

    The pain will be analyzed by the FLACC

  3. Self-perception of pain

    Time frame: Immediately after anesthesia

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

Secondary outcomes

  1. SCARED Questionnaire

    Time frame: Before anesthesia

    Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire

  2. Corah Questionnaire

    Time frame: Before anethesia

    Children will be evaluated for the dentistry anxiety prior to any anesthesia

  3. VPT modified

    Time frame: Before anethesia and immediately after anesthesia

    Children will be evaluated for the anxiety after to any anesthesia

  4. Blood pressure

    Time frame: Immediately before anesthesia, during anesthesia

    The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of blood pressure

  5. Respiratory rate

    Time frame: Immediately before anesthesia, during anesthesia

    The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate

  6. Heart rate

    Time frame: Immediately before anesthesia, during anesthesia

    The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate

  7. Oxygen saturation

    Time frame: Immediately before anesthesia, during anesthesia

    The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation

  8. Salivary cortisol

    Time frame: Immediately before anesthesia, during anesthesia

    The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol

Sponsors and collaborators

Lead sponsor

Universidade Estadual de Ponta Grossa

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 5, 2017
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.