Dental Anxiety, Heart Rate and Rhythm Disorders, Infant Behavior, Pain
Conditions
Keywords
pain, Infant Behavior, Heart rate, Dental Anxiety
Brief summary
This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of Hands/Eyes/mouth behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.
Detailed description
Children will be randomly allocated to treatment groups (n=26 for each group) according to the technique: 1)Hands/Eyes/mouth and 2) Conventional. Anxiety and pain will be evaluated by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral Scale Frank
Interventions
The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines: 1. Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). 2. Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) 3. anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). 4. Syringe: carpule syringe-conventional harpoon with suction system.
Sponsors
Cardenal Herrera University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
36 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
* Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars
Exclusion criteria
* Preschool children with history of allergies to lidocaine (local anesthetic) * Preschool children with systemic or neurological diseases * Preschool children who have received local dental anesthesia before this study * Preschool children who do not understand Spanish or Valencian language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preschool children´s anxiety levels-Facial Image Scale (FIS) | Baseline | The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy-FIS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preschool children´s pain levels-Wong Baker Faces Pain Scale | At the end of local anesthesia procedure (2 minutes) | The children will be asked to point at which face they felt most like at that moment (row of six faces ranging from very happy-does not hurt to very unhappy-hurt as much as you can imagine) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preschool children´s behavior-Frank behavioral rating Scale | baseline and during the local anesthesia procedure (2 minutes) | It will be evaluated children´s behavior (definitely negative, negative,definitely positive, positive)during the local anethesia procedure |
| Heart rates | baseline and during the local anesthesia procedure (2 minutes) | — |
Countries
Spain
Outcome results
None listed