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

Not Applicable

Not yet recruiting

• Conditions: Restorative Dental Treatment by Buccal Infiltration Anaesthesia
• Interventions: Other: 4% articaine infiltration

• Registration Number: NCT06353815
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-31
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Study Start: 2024-07
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (Control group) 4% articaine inferior alveolar nerve block	4% articaine infiltration	-
Group I (Experimental group) 4% articaine infiltration	4% articaine infiltration	-

Primary Outcome Measures

Name	Time	Method
Success of local anesthesia	10 minutes	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

Secondary Outcome Measures

Name	Time	Method
Child behavior during treatment	Intraoperative	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