An interventional study of Local anesthesia with traditional technique and Local anesthesia with computerized technique in Pediatric Dentistry, Local Anesthesia and Pain Management, sponsored by Universidade Estadual de Ponta Grossa. Completed at 1 site in Brazil. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.
Sponsored by Universidade Estadual de Ponta Grossa · Not applicable, Interventional, and Device feasibility
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.
Exclusion Criteria:
The children anesthesia will be traditional technique
Device: Local anesthesia with traditional technique · Drug: Topic anesthesia · Drug: Local anesthetic
The children anesthesia will be computerized technique
Device: Local anesthesia with computerized technique · Drug: Topic anesthesia · Drug: Local anesthetic
The children anesthesia will be DentalVibe technique
Device: Local anesthesia with DentalVibe technique · Drug: Topic anesthesia · Drug: Local anesthetic
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
Also known as: Traditional anesthesia, Conventional 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
Also known as: Computerized 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
Also known as: DentalVibe anesthesia
Application of topical anesthetic for 60 seconds with benzocaine
Also known as: Topical anesthesia
2% lidocaine with epinephrine 1: 100000 1.8 mL
Also known as: Anesthetic
Self-perception of pain
The pain will be analyzed by the Wong Baker Faces scales
Time frame: Immediately after anesthesia
Pain Behavior
The pain will be analyzed by the FLACC
Time frame: 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
Time frame: Immediately after anesthesia
SCARED Questionnaire
Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire
Time frame: Before anesthesia
Corah Questionnaire
Children will be evaluated for the dentistry anxiety prior to any anesthesia
Time frame: Before anethesia
VPT modified
Children will be evaluated for the anxiety after to any anesthesia
Time frame: 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
Time frame: Immediately before anesthesia, during anesthesia
Respiratory rate
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate
Time frame: Immediately before anesthesia, during anesthesia
Heart rate
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate
Time frame: Immediately before anesthesia, during anesthesia
Oxygen saturation
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation
Time frame: Immediately before anesthesia, during anesthesia
Salivary cortisol
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol
Time frame: Immediately before anesthesia, during anesthesia
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidade Estadual de Ponta Grossa