Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block

N/ANot Yet RecruitingNCT06353815

Cairo University44 enrolled

Overview

Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Restorative Dental Treatment by Buccal Infiltration Anaesthesia

Interventions

4% articaine infiltrationOTHER

Two injections using short needle and dental syringe will be given , the first injection is 1.5 ml out of 1.8 ml of 4% articaine with 1:100,000 epinephrine (ARTINIBSA 4% 1:100,000) in the mucobuccal fold adjacent to the mandibular first Molar, the second injection is 0.3 ml in the lingual side for lingual soft and hard tissues .

Eligibility

Sex: ALLMin age: 6 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical Criteria: * Children aged between 6 years and 9 years having: * Mandibular first permanent molar with simple caries not involving pulp showing the following criteria: A. No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. B. Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test. Radiographic criteria: * No sign of radiolucency in periapical or furcation area. * No widening of PDL space or loss of lamina dura continuity. * No evidence of internal/external pathologic root resorption Exclusion Criteria: * • Uncooperative children. * Children with systemic disease. * Lack of informed consent by the child patient's parent. * Refusal of participation. * Allergy from anesthetic agent. * Acute infection

Outcomes

Primary Outcomes

Success of local anesthesia

Operator will record the LA as Successful if the scheduled restorative treatment was completed with standard treatment management strategies after administration of the trial anaesthetic. If treatment could not be continued after 10 minutes from when the LA was first administered, and the full 1.8 ml cartridge of the trial anaesthetic had been used, then the LA was considered unsuccessful

Time frame: 10 minutes

Secondary Outcomes

Child behavior during treatment

Doaa Moustafa: he patient's behavior will be evaluated for pain perception during treatment using the SEM scale (Appendix 3: SEM scale ). The SEM scale is an objective pain \[10:04 pm, 31/3/2024\] Doaa Moustafa: assessment scale with scores ranging from 1 to 4, illustrating comfort to severe discomfort based on sounds, eye, motor parameters

Time frame: Intraoperative

Central Contacts

Doaa Moustafa, bachelor's degree

CONTACT

01064174546 Doaa.moustafa@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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