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Clinical Trials/NCT05193487
NCT05193487
Unknown
Not Applicable

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

Ain Shams University1 site in 1 country88 target enrollmentNovember 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Anaesthesia
Sponsor
Ain Shams University
Enrollment
88
Locations
1
Primary Endpoint
Patient's level of cooperation
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2021
End Date
November 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mariem Wassel

Clinical assistant professor

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patient's level of cooperation

Time Frame: 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 Outcomes

  • Heart Rate(before injection, during injection and directly after injection.)
  • Anesthesia success or failure(directly after anesthetic injection while providing the dental treatment)

Study Sites (1)

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