Intraosseous Anesthesia Versus Mandibular Nerve Block in Children

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

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

Study Overview

• Status: Recruiting
• Conditions: Dental Anaesthesia
• Intervention / Treatment: Other: inferior alveolar nerve block; Other: intra-osseous mandibular anaesthesia

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 Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Zayed, lecturer; Phone Number: +20 01111480002; Email: mradwan@dent.asu.edu.eg
• Study Contact Backup: Name: Mariem Wassel; Email: mariem.wassel@dent.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 1156
    • Recruiting
    • Faculty of dentistry, ain shams university
    • Contact: Mohamed Diaa, Professor; Phone Number: 02 22639088; Email: diaa67@dent.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

1. Children aging between 6-9 years with no history of previous local dental anesthesia experience.
2. American society of anesthesiologists score equal to or less than II
3. Lower 2nd primary molars requiring pulpotomy

Exclusion criteria:

1. American society of anesthesiologists Score more than II
2. Uncompliant, Uncooperative children
3. Children turning non-compliant during procedure
4. Patients taking analgesics and anti-inflammatory
5. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mohamed Zayed, lecturer, Faculty of Dentistry, Ain Shams University, Cairo, Eypt

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 25, 2021
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 15, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: inferior alveolar nerve block; intra-osseous anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: FDASU-Rec R102110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No