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

Anesthetic Efficacy of 1.8 ml Compared to 3.6 ml of Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06119139
Enrollment
70
Registered
2023-11-07
Start date
2023-12-31
Completion date
2025-06-30
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Irreversible Pulpitis

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.

Detailed description

Patients with moderate-to-severe pain due to symptomatic irreversible pulpitis will be included. Patients will be randomly assigned into two groups to receive either 1.8 ml 4% articaine buccal infiltration or 3.6. ml 4% articaine buccal infiltration before single visit root canal treatments. Intraoperative pain will be assessed using an 11-point numerical rating scale (NRS) so that anesthetic success will be defined as no to mild intraoperative pain. The need for supplemental anesthesia will also be recorded.

Interventions

DRUG3.6 ml 4% Articaine hydrochloride

3.6 ml 4% articaine buccal infiltration

DRUG1.8 ml 4% Articaine hydrochloride

1.8 ml 4% articaine buccal infiltration

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Parallel, randomized, clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists (ASA class I or II). 2. No sex predilection 3. Patients with symptomatic irreversible pulpitis 4. Patient with the ability to understand and use pain scales. 5. Patients who accept to enroll in the study.

Exclusion criteria

1. Patients' allergies to any of the drugs or materials used in the study. 2. Pregnant and lactating females. 3. Patients taking analgesics in the last 6-8 hours. 4. Patients having more than one symptomatic tooth in the same quadrant

Design outcomes

Primary

MeasureTime frameDescription
Anesthetic successDuring the procedureWill 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).

Secondary

MeasureTime frameDescription
Need for supplemental anesthesiaDuring the procedureWhether the patient requires supplemental anesthesia or not. It will be recorded by the questionnaire (yes or no).

Contacts

Primary ContactHebatullah Moheb Ibrahim
heba.eid@dentistry.cu.edu.eg00201114563058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026