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NCT Number: NCT01912755

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

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.

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Key information

Conditions

Irreversible Pulpitis Dental Pulp Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pulpitis Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Piracicaba Dental School - UNICAMP

Piracicaba, São Paulo, 13414-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% articaine with 1:100,000 epinephrine

Drug

If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.

Other names: articaine

2% lidocaine with 1:100,000 epinephrine

Drug

If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.

Other names: Lidocaine

Primary outcomes

  1. Pain perception 3

    Time frame: 10 minutes after injection

    Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.

Secondary outcomes

  1. Buccal cortical bone thickness

    Time frame: 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.

  2. Root distance to the bone

    Time frame: 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.

  3. Basal pain perception

    Time frame: 10 minutes before injection

    Patients received visual analogue scales (VAS) to record their pain perception 10 min before the local anesthetic injection.

  4. Pain perception 2

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 31, 2013
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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