drugset / Trial / NCT03176446

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

NCT03176446

Completed 210 enrolled Universidade Estadual de Ponta Grossa
RandomizedParallel-groupSingle-blindDevice feasibility

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.

Timeline

Start
2017-10-01
Primary completion
2018-11-30
Completion
2019-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benzocaine Small molecule Topical
Comparator Epinephrine Other / unclassified Other
Comparator Lidocaine Other / unclassified 2 % Other

Indications

No indication recorded.