Different Volumes of Articaine for Inferior Alveolar Nerve Block in Irreversible Pulpitis

NCT05840913 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Articaine Efficacy for IANB
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized controlled 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

Conditions

Drug Effect; Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• Pain Control

  Pain was recorded on a self-report questionnaire using the visual analog pain scale (VAS) VAS was used for gauging pain before the administration of the anesthetic solution, after the cold test was performed, and during the endodontic therapy. The VAS scores were designated as; 0= no pain 1-3= mild pain 4-7= moderate pain 8-10= severe pain

  30 to 45 minutes

Study Arms (2)

1.8 ml group

EXPERIMENTAL

Participants in this group will be given 1 cartridge of articaine solution pre-operatively to endodontic treatment

Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge

3.6 ml group

EXPERIMENTAL

Participants in this group will be given 2 cartridges of articaine solution pre-operatively to endodontic treatment

Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge

Interventions

Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge DRUG

Local anesthetic injection for intra- operative pain control

Also known as: Orabloc 4% Articaine 1:100,000 1.8 ml

1.8 ml group; 3.6 ml group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (2)

Armed Forces Institue Of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Interventions

Carticaine; Epinephrine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kanza Zafar, BDS

  AFID

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kanza Zafar, Principal Investigator and Resident Operative Dentistry and Endodontics

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: May 3, 2023
• Study Start: December 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)