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

Symptomatic Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05238727
• Other study ID #: CU-ENDO-2-2-2022.
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: September 2023

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: Reham Anwar Sleem
• Phone: 00201014110666
• Email: reham.anwar[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Drug:
• 1.8 ml mepivacaine hydrochloride
1.8 ml mepivacaine IANB
• 3.6 ml mepivacaine hydrochloride
3.6 ml mepivacaine IANB
• 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI
1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthetic success	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.	During the treatment
Secondary	Intraoperative pain	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".	During the treatment
Secondary	Need for supplemental anesthesia	Whether the patient requires supplemental anesthesia or not	During the treatment