Intraosseous Anesthesia Versus Mandibular Nerve Block in Children

Ain Shams University

Status: Unknown

Conditions: Dental Anaesthesia

Treatments: Other: inferior alveolar nerve block; Other: intra-osseous mandibular anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05193487

FDASU-Rec R102110

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

inferior alveolar nerve block

Active Comparator group

Description:

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

Treatment:

Other: inferior alveolar nerve block

intra-osseous mandibular anaesthesia

Experimental group

Description:

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

Treatment:

Other: intra-osseous mandibular anaesthesia