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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05193487
Enrollment
88
Registered
2022-01-18
Start date
2021-11-04
Completion date
2022-11-01
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anaesthesia

Keywords

intra-osseous anesthesia, inferior alveolar nerve block

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.

Interventions

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

OTHERintra-osseous mandibular anaesthesia

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient's level of cooperationdirectly after anesthetic injection while providing the dental treatmentThe child behavior will be evaluated using the modified Venham scale (scores 0-5) where higher scores indicate uncooperative behavior

Secondary

MeasureTime frameDescription
Heart Ratebefore injection, during injection and directly after injection.Heart Rate (physiological measure)
Anesthesia success or failuredirectly after anesthetic injection while providing the dental treatmentCompleting the needed treatment will be recorded as anesthesia success while failure to complete pulpotomy due to pain will be recorded as anesthesia failure

Countries

Egypt

Contacts

Primary ContactMohamed Zayed, lecturer
mradwan@dent.asu.edu.eg+20 01111480002
Backup ContactMariem Wassel
mariem.wassel@dent.asu.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026