Clinical trial NCT01912755: Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits
Official title: Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irreversible Pulpitis
Pain
Keywords: Pulpitis
Hot tooth
Articaine
Lidocaine
Local anesthetics
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain perception 3
timeFrame: 10 minutes after injection
Secondary outcomes:
measure: Buccal cortical bone thickness
timeFrame: one week after injection
measure: Root distance to the bone
timeFrame: one week after injection
measure: Basal pain perception
timeFrame: 10 minutes before injection
measure: Pain perception 2
timeFrame: 5 minutes before injection
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School - UNICAMP
state: SP
Study officials:
affiliation: Endodontics Area - FOP-UNICAMP
name: José FA Almeida, DDS, PhD
role: STUDY_CHAIR
affiliation: Endodontics Area - FOP-UNICAMP
name: Maria RF Monteiro, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aggarwal V, Jain A, Kabi D. Anesthetic efficacy of supplemental buccal and lingual infiltrations of articaine and lidocaine after an inferior alveolar nerve block in patients with irreversible pulpitis. J Endod. 2009 Jul;35(7):925-9. doi: 10.1016/j.joen.2009.04.012.
citation: Ashraf H, Kazem M, Dianat O, Noghrehkar F. Efficacy of articaine versus lidocaine in block and infiltration anesthesia administered in teeth with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2013 Jan;39(1):6-10. doi: 10.1016/j.joen.2012.10.012. Epub 2012 Nov 13.
citation: Berlin J, Nusstein J, Reader A, Beck M, Weaver J. Efficacy of articaine and lidocaine in a primary intraligamentary injection administered with a computer-controlled local anesthetic delivery system. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Mar;99(3):361-6. doi: 10.1016/j.tripleo.2004.11.009.
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.