Intraosseous Anesthesia Versus Mandibular Nerve Block in Children

Study Overview
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Brief Summary
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The aim of the current study is to compare a new computerized intra-osseous injection system to the conventional inferior alveolar nerve block in children

Detailed Description
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Patients will be randomly allocated to one of the experimental groups.: Conventional (Inferior alveolar nerve block) and Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France). Both techniques will be performed by a single trained operator. Articaine 4% with 1/200000 Adrenaline will be used for both techniques.

Official Title
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Influence Of Computerized Intraosseous Anesthesia On Children's Behaviour In Comparison To Traditional Mandibular Nerve Block Technique: A Randomized Clinical Trial

Conditions
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Dental Anaesthesia

Intervention / Treatment
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* Other: inferior alveolar nerve block
* Other: intra-osseous mandibular anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Children aging between 6-9 years with no history of previous local dental anesthesia experience. American society of anesthesiologists score equal to or less than II Lower 2nd primary molars requiring pulpotomy Exclusion criteria: American society of anesthesiologists Score more than II Uncompliant, Uncooperative children Children turning non-compliant during procedure Patients taking analgesics and anti-inflammatory Un-restorable teeth, teeth near exfoliation, teeth with gingival abscess/fistula, pathological mobility, pain on percussion, radiographic evidence of internal or external pathological root resorption, periapical/furcation radio-lucencies, widened periodontal membrane space.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: inferior alveolar nerve block<br>Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe | Other: inferior alveolar nerve block<br>* inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection<br>|
| Experimental: intra-osseous mandibular anaesthesia<br>Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France) | Other: intra-osseous mandibular anaesthesia<br>* intra-osseous mandibular anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intra-osseous injection device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's level of cooperation | The child behavior will be evaluated using the modified Venham scale (scores 0-5) where higher scores indicate uncooperative behavior | directly after anesthetic injection while providing the dental treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart Rate (physiological measure) | before injection, during injection and directly after injection. | 
| Anesthesia success or failure | Completing the needed treatment will be recorded as anesthesia success while failure to complete pulpotomy due to pain will be recorded as anesthesia failure | directly after anesthetic injection while providing the dental treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-osseous anesthesia, inferior alveolar nerve block