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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel, randomized, clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1.8 ml 4% articaine buccal infiltration.

Group Type ACTIVE_COMPARATOR

1.8 ml 4% Articaine hydrochloride

Intervention Type DRUG

1.8 ml 4% articaine buccal infiltration

3.6 ml 4% articaine buccal infiltration

Group Type EXPERIMENTAL

3.6 ml 4% Articaine hydrochloride

Intervention Type DRUG

3.6 ml 4% articaine buccal infiltration

Interventions

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3.6 ml 4% Articaine hydrochloride

3.6 ml 4% articaine buccal infiltration

Intervention Type DRUG

1.8 ml 4% Articaine hydrochloride

1.8 ml 4% articaine buccal infiltration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No