Intraosseous Anesthesia Versus Mandibular Nerve Block in Children

NCT05193487 | Unknown

• 1 other identifier: FDASU-Rec R102110
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Anaesthesia

Keywords

intra-osseous anesthesia; inferior alveolar nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart Rate

  before injection, during injection and directly after injection.

• Anesthesia success or failure

  directly after anesthetic injection while providing the dental treatment

Study Arms (2)

inferior alveolar nerve block

ACTIVE COMPARATOR

Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe

Other: inferior alveolar nerve block

intra-osseous mandibular anaesthesia

EXPERIMENTAL

Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France)

Other: intra-osseous mandibular anaesthesia

Interventions

inferior alveolar nerve block OTHER

inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection

inferior alveolar nerve block

intra-osseous mandibular anaesthesia OTHER

intra-osseous mandibular anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intra-osseous injection device

intra-osseous mandibular anaesthesia

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 1156, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 38923102 DERIVED

Study Officials

• Mohamed Zayed, lecturer

  Faculty of Dentistry, Ain Shams University, Cairo, Eypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Zayed, lecturer

CONTACT

+20 01111480002; mradwan@dent.asu.edu.eg

Mariem Wassel

CONTACT

mariem.wassel@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 18, 2022
• Study Start: November 4, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)