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

Not Applicable

Not yet recruiting

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Drug: 1.8 ml 4% Articaine hydrochloride; Drug: 3.6 ml 4% Articaine hydrochloride

• Registration Number: NCT06119139
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-10-31
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Study Start: 2023-12
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.8 ml 4% articaine buccal infiltration.	1.8 ml 4% Articaine hydrochloride	-
3.6 ml 4% articaine buccal infiltration	3.6 ml 4% Articaine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Anesthetic success	During the procedure	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).

Secondary Outcome Measures

Name	Time	Method
Need for supplemental anesthesia	During the procedure	Whether the patient requires supplemental anesthesia or not. It will be recorded by the questionnaire (yes or no).