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Clinical trial

Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth With Symptomatic Irreversible Pulpitis

ID
Name
Articaine Efficacy for IANB
Description
This is a randomized clinical trial comparing the anaesthetic efficacy of 1.8 and 3.6 mL of Articaine for inferior alveolar nerve block when treating mandibular molars with Irreversible Pulpitis
Trial arms
Trial start
2023-04-30
Estimated PCD
2023-10-30
Trial end
2023-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
Local anesthetic injection for intra- operative pain control
Arms:
1.8 ml group, 3.6 ml group
Other names:
Orabloc 4% Articaine 1:100,000 1.8 ml
Size
78
Primary endpoint
Pain Control
30 to 45 minutes
Eligibility criteria
Inclusion Criteria: * Healthy patients, including age group 18-55 years old * Mandibular first molar tooth with symptomatic irreversible pulpitis * Normal periapical radiographic appearance * Moderate pain on Heft-Parker VAS ( \> 54 mm and \< 114 mm ) * Lingering pain or prolonged response to the cold testing (more than 10 seconds) * Positive response to electric pulp testing Exclusion Criteria: * Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit * History of allergy to 4% articaine or epinephrine * Patients with systemic diseases * Pregnant or lactating patients * Teeth with severe periodontal disease * Teeth with periapical radiolucency * Any type of medication that could potentially interact with the anesthetic solution (antihypertensives)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}
Updated at
2023-05-03

1 organization

1 product

2 indications

Organization
Armed Forces Institute of Dentistry
Product
Articaine HCl / EPINEPHrine
Indication
Drug Effect
Indication
Pulpitis - Irreversible