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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "hand-eye-mouth" technique | Experimental | "hand-eye-mouth" (MOB) seeks to focus the patient in performing a sequence of movements in a fun way so that your attention is diverted from the puncture dental needle, also it seeks to the patient does not see the needle. The operator prior to infiltrate local anesthetic teaches the child a "game" to put "the sleepy little water".After explain a first time, the sequence once or twice is repeated until the patient has mastered. We call this test. When we apply the anesthetic, the entire sequence must be repeated as in trials with the same tranquility and in the same tone of the game. The operator will use this technique during the inferior alveolar and lingual nerve block procedure |
|
| Conventional technique | Active Comparator | the operator will explain how he/she will do the inferior alveolar and lingual nerve block procedure in phrases appropriates to the child. Then quietly cover the child´s field of view by hand during the inferior alveolar and lingual nerve block |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inferior alveolar and lingual nerve block procedure | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Preschool children´s anxiety levels-Facial Image Scale (FIS) | 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) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Preschool children´s pain levels-Wong Baker Faces Pain Scale | 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) | At the end of local anesthesia procedure (2 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Preschool children´s behavior-Frank behavioral rating Scale | It will be evaluated children´s behavior (definitely negative, negative,definitely positive, positive)during the local anethesia procedure | baseline and during the local anesthesia procedure (2 minutes) |
| Heart rates |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Ribelles Llop, PhD | Director of Pediatric Dentistry Master. Cardenal Herrera CEU University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de OdontologÃa. Universidad Cardenal Herrera CEU | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36260279 | Derived | Leyda-Menendez AM, Vidigal EA, Abanto J, Ribelles-Llop M. Efficacy of two behavioural management techniques during inferior alveolar nerve block administration in pre-school children: a randomised clinical trial. Eur Arch Paediatr Dent. 2023 Feb;24(1):85-93. doi: 10.1007/s40368-022-00758-y. Epub 2022 Oct 19. |
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|
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| baseline and during the local anesthesia procedure (2 minutes) |
| ID | Term |
|---|---|
| D010146 | Pain |
| D018730 | Infant Behavior |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002652 | Child Behavior |
| D001519 | Behavior |
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