Clinical trial NCT05238727: Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success
Official title: Effect of Volume Increase Compared to Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success in Cases With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anesthetic success
timeFrame: During the treatment
Secondary outcomes:
measure: Intraoperative pain
timeFrame: During the treatment
measure: Need for supplemental anesthesia
timeFrame: During the treatment
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Aggarwal V, Singla M, Miglani S, Kohli S, Singh S. Comparative evaluation of 1.8 mL and 3.6 mL of 2% lidocaine with 1:200,000 epinephrine for inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, randomized single-blind study. J Endod. 2012 Jun;38(6):753-6. doi: 10.1016/j.joen.2012.02.003. Epub 2012 Mar 3.
citation: Parirokh M, Satvati SA, Sharifi R, Rekabi AR, Gorjestani H, Nakhaee N, Abbott PV. Efficacy of combining a buccal infiltration with an inferior alveolar nerve block for mandibular molars with irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):468-73. doi: 10.1016/j.tripleo.2009.11.016.