Intraosseous Anesthesia Versus Mandibular Nerve Block in Children

Not Applicable

• Conditions: Dental Anaesthesia
• Interventions: Other: intra-osseous mandibular anaesthesia; Other: inferior alveolar nerve block

• Registration Number: NCT05193487
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-11-04
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-15
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intra-osseous mandibular anaesthesia	intra-osseous mandibular anaesthesia	Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France)
inferior alveolar nerve block	inferior alveolar nerve block	Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt