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

Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block for Restorative Dental Treatment in Mandibular First Permanent Molars: A Randomized Clinical Tria

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 Overview

• Status: Not yet recruiting
• Conditions: Restorative Dental Treatment by Buccal Infiltration Anaesthesia
• Intervention / Treatment: Other: 4% articaine infiltration

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doaa Moustafa, bachelor's degree; Phone Number: 01064174546; Email: Doaa.moustafa@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Experimental group) 4% articaine infiltration	Other: 4% articaine infiltration; 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 .
Active Comparator: Group II (Control group) 4% articaine inferior alveolar nerve block	Other: 4% articaine infiltration; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intraoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: buccal infiltration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Carticaine
• Other Study ID Numbers: anaesthetic efficacy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No