Local Anesthesia, Pain Management, Pediatric Dentistry
Conditions
Brief 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.
Interventions
DEVICELocal anesthesia with traditional technique
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
DEVICELocal anesthesia with computerized technique
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
DEVICELocal anesthesia with DentalVibe technique
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
DRUGTopic anesthesia
Application of topical anesthetic for 60 seconds with benzocaine
DRUGLocal anesthetic
2% lidocaine with epinephrine 1: 100000 1.8 mL
Sponsors
Universidade Estadual de Ponta Grossa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Investigator)
Intervention model description
The total sample is divided into two subgroups, with 105 children aged 5 to 8 years and 105 children aged 9 to 12 years. The analysis is more sensitive and specific to each subgroup. The results of each subgroup will be analyzed in isolation and give rise to two different papers.
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| SCARED Questionnaire | Before anesthesia | Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire |
| 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 |
| Heart rate | Immediately before anesthesia, during anesthesia | The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate |
| Corah Questionnaire | Before anethesia | Children will be evaluated for the dentistry anxiety prior to any anesthesia |
Countries
Brazil
Outcome results
None listed