Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits

Phase 4

Completed

• Conditions: Pain; Irreversible Pulpitis

• Registration Number: NCT01912755
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.

Detailed Description

Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-11
• Study Completion: 2011-01
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• long-lasting moderate to severe pain during cold test
• absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs)
• vital coronal pulp on access opening

Exclusion Criteria

• Previous history of allergy to local anesthetics
• Subjects with systemic diseases
• Pregnancy and lactation
• Subjects taking any kind of medication that could change or influence the outcome of this research
• Subjects without painful symptoms
• Negative thermal testing, periapical lesion, incomplete root formation, presence of fistula or abscess, cracks or fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain perception 3	10 minutes after injection	Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.

Secondary Outcome Measures

Name	Time	Method
Buccal cortical bone thickness	one week after injection	Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the buccal cortical bone thickness.
Pain perception 2	5 minutes before injection	Patients received visual analogue scales (VAS) to record their pain perception 5 min before the local anesthetic injection (after the cold testing).
Basal pain perception	10 minutes before injection	Patients received visual analogue scales (VAS) to record their pain perception 10 min before the local anesthetic injection.
Root distance to the bone	one week after injection	Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the the distance between the mesial and lingual roots to the buccal cortical bone.

Trial Locations

Locations (1)

Piracicaba Dental School - UNICAMP; 🇧🇷 Piracicaba, SP, Brazil