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Trials / Completed

CompletedNCT03176446

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
210 (actual)
Sponsor
Universidade Estadual de Ponta Grossa · Academic / Other
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICELocal anesthesia with traditional techniquePuncture with short needle in the region of the apical third of the tooth to be anesthetized Injection of local anesthetic, with speed 1ml / min
DEVICELocal anesthesia with computerized techniquePuncture 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
DEVICELocal anesthesia with DentalVibe techniqueUse 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
DRUGTopic anesthesiaApplication of topical anesthetic for 60 seconds with benzocaine
DRUGLocal anesthetic2% lidocaine with epinephrine 1: 100000 1.8 mL

Timeline

Start date
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 across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03176446. Inclusion in this directory is not an endorsement.