Anesthetic Efficacy of 1.8 ml Versus 3.6 ml of 4% Articaine Buccal Infiltration

NCT06119139 | Unknown

• 1 other identifier: CU-Endo.23.10.23
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to compare the anesthetic efficacy and need for supplemental anesthesia of 1.8 ml compared to 3.6 ml of 4% articaine buccal infiltration in mandibular molars with symptomatic irreversible pulpitis.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Anesthetic success

  Will be measured by 11-point numerical rating scale NRS. The success will be defined as no or mild pain (NRS 0 or less than 3) and the failure will be defined as moderate to severe pain (NRS more than 3).

  During the procedure

Secondary Outcomes (1)

• Need for supplemental anesthesia

  During the procedure

Study Arms (2)

1.8 ml 4% articaine buccal infiltration.

ACTIVE COMPARATOR

Drug: 1.8 ml 4% Articaine hydrochloride

3.6 ml 4% articaine buccal infiltration

EXPERIMENTAL

Drug: 3.6 ml 4% Articaine hydrochloride

Interventions

3.6 ml 4% Articaine hydrochloride DRUG

3.6 ml 4% articaine buccal infiltration

3.6 ml 4% articaine buccal infiltration

1.8 ml 4% Articaine hydrochloride DRUG

1.8 ml 4% articaine buccal infiltration

1.8 ml 4% articaine buccal infiltration.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists (ASA class I or II).
• No sex predilection
• Patients with symptomatic irreversible pulpitis
• Patient with the ability to understand and use pain scales.
• Patients who accept to enroll in the study.

You may not qualify if:

• Patients' allergies to any of the drugs or materials used in the study.
• Pregnant and lactating females.
• Patients taking analgesics in the last 6-8 hours.
• Patients having more than one symptomatic tooth in the same quadrant

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Poorni S, Veniashok B, Senthilkumar AD, Indira R, Ramachandran S. Anesthetic efficacy of four percent articaine for pulpal anesthesia by using inferior alveolar nerve block and buccal infiltration techniques in patients with irreversible pulpitis: a prospective randomized double-blind clinical trial. J Endod. 2011 Dec;37(12):1603-7. doi: 10.1016/j.joen.2011.09.009.

  PMID: 22099890 BACKGROUND

• Abazarpoor R, Parirokh M, Nakhaee N, Abbott PV. A Comparison of Different Volumes of Articaine for Inferior Alveolar Nerve Block for Molar Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2015 Sep;41(9):1408-11. doi: 10.1016/j.joen.2015.05.015. Epub 2015 Jul 3.

  PMID: 26149210 BACKGROUND

• Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.

  PMID: 24702239 BACKGROUND

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hebatullah Moheb Ibrahim

CONTACT

00201114563058; heba.eid@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Parallel, randomized, clinical trial

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11