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

Symptomatic Irreversible Pulpitis Clinical Trial

Official title:

Anesthetic Efficacy of 1.8 ml Compared to 3.6 ml of Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119139
• Other study ID #: CU-Endo.23.10.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: Hebatullah Moheb Ibrahim
• Phone: 00201114563058
• Email: heba.eid[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Drug:
• 3.6 ml 4% Articaine hydrochloride
3.6 ml 4% articaine buccal infiltration
• 1.8 ml 4% Articaine hydrochloride
1.8 ml 4% articaine buccal infiltration

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

Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22. — View Citation

Poorni S, Veniashok B, Senthilkumar AD, Indira R, Ramachandran S. Anesthetic efficacy of four percent articaine for pulpal anesthesia by using inferior alveolar nerve block and buccal infiltration techniques in patients with irreversible pulpitis: a prospective randomized double-blind clinical trial. J Endod. 2011 Dec;37(12):1603-7. doi: 10.1016/j.joen.2011.09.009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthetic success	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).	During the procedure
Secondary	Need for supplemental anesthesia	Whether the patient requires supplemental anesthesia or not. It will be recorded by the questionnaire (yes or no).	During the procedure