Clinical trial

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

Name
2009-10834-4
Description
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.
Trial arms
Trial start
2010-02-01
Estimated PCD
2010-11-01
Trial end
2011-01-01
Status
Completed
Phase
Early phase I
Treatment
4% articaine with 1:100,000 epinephrine
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.
Arms:
Articaine, Lidocaine
Other names:
articaine
2% lidocaine with 1:100,000 epinephrine
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.
Arms:
Articaine, Lidocaine
Other names:
Lidocaine
Size
50
Primary endpoint
Pain perception 3
10 minutes after injection
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-05-08

1 organization

2 products

2 indications

Indication
Pulpitis
Indication
Pain