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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inferior alveolar nerve block | Active Comparator | Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe |
|
| intra-osseous mandibular anaesthesia | Experimental | Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inferior alveolar nerve block | Other | inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection |
|
| 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 |
| 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 |
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Inclusion criteria
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Zayed, lecturer | Contact | +20 01111480002 | mradwan@dent.asu.edu.eg | |
| Mariem Wassel | Contact | mariem.wassel@dent.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Zayed, lecturer | Faculty of Dentistry, Ain Shams University, Cairo, Eypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Ain Shams University | Recruiting | Cairo | 1156 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38923102 | Derived | Radwan MZ, Wassel MO, El Geleel OA, Elghazawy RK. Influence of computerized intraosseous anesthesia compared with traditional mandibular nerve block on children's behavior: A randomized clinical trial. Int J Paediatr Dent. 2025 Mar;35(2):281-288. doi: 10.1111/ipd.13231. Epub 2024 Jun 24. |
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| intra-osseous mandibular anaesthesia | Other | intra-osseous mandibular anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intra-osseous injection device |
|
| directly after anesthetic injection while providing the dental treatment |