Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success

Not Applicable

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Drug: 3.6 ml mepivacaine hydrochloride; Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI; Drug: 1.8 ml mepivacaine hydrochloride

• Registration Number: NCT05238727
• Lead Sponsor: Cairo University

Brief Summary

To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic irreversible pulpitis.

Detailed Description

Patients with moderate-to-severe preoperative pain related to mandibular molars with symptomatic irreversible pulpitis will be included. Patients receive 1.8 ml, 3.6 ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine BI. Anesthetic success of inferior alveolar nerve block, intraoperative pain intensity and need for supplemental anesthesia will be assessed during treatment.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-14
• Last Update Posted: 2022-02-14
• Study Start: 2022-03
• Primary Completion: 2023-03
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Patients in good health (ASA Class I, II).
2. Age between 18-60 years old.
3. Males or females.
4. Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
5. Patients who can understand NRS scale and sign the informed consent.

Exclusion Criteria

1. Patients who had used any type of analgesic medication during the preceding 8 hours before the treatment.
2. Pregnant or nursing females.
3. Patients with a contraindication for the use of mepivacaine, articaine or any used drug or material.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3.6 ml mepivacaine IANB	3.6 ml mepivacaine hydrochloride	-
1.8 ml mepivacaine IANB plus 1.8 ml articaine BI	1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI	-
1.8 ml mepivacaine IANB	1.8 ml mepivacaine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Anesthetic success	During the treatment	Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.

Secondary Outcome Measures

Name	Time	Method
Intraoperative pain	During the treatment	Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain".
Need for supplemental anesthesia	During the treatment	Whether the patient requires supplemental anesthesia or not