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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02054767
Other study ID # FDAAA
Secondary ID
Status Completed
Phase Phase 4
First received September 3, 2013
Last updated January 31, 2014
Start date August 2010
Est. completion date July 2013

Study information

Verified date September 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.


Description:

Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 2013
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- clinical diagnosis of irreversible pulpitis

- good health

- had at least 1 adjacent tooth plus a healthy canine

Exclusion Criteria:

- took medication could be interacting with any of the anesthetics used

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Intervention: inferior alveolar nerve block injection
-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)

Locations

Country Name City State
Brazil Emergency Center of the School of Dentistry at the University of São Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other lip anesthesia The investigators evaluated the subjective lip anethesia by asking the patient whether his/her lip was numb ten minutes after the inferior alveolar nerve block No
Primary pulpal anesthesia pulpal anesthesia was tested with an electric pulp stimulator Ten minutes after the inferior alveolar nerve block No
Secondary analgesia To evaluate the intensity of pain during the pulpectomy a verbal analogic scale was adopted the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal No
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