Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars

NCT03106168 | Unknown DMC

• 1 other identifier: Extraction
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate subjectively and objectively the quality and efficacy of local anesthetic block with mepivacaine in simple extraction of mandibular molar. Provide and collect information such as: signs and symptoms, quality of anesthetic block, quantify pain and / or discomfort, as well as medication used, both preoperatively and postoperatively.

Conditions

Local Anesthetics; Tooth Extraction

Keywords

Extraction; Local Anesthetic; Mepivacaine; Mandibular Molar

Outcome Measures

Primary Outcomes (1)

• Anesthetic efficacy

  The anesthetic efficacy will be analyzed through the use of a verbal numerical scale used during the pulpectomy procedure

  10 minutes after anesthetic technique

Secondary Outcomes (2)

• Pulpal Anesthesia

  10 minutes after anesthetic technique

• Postoperative pain

  seven days after the extraction

Study Arms (2)

With periapical granuloma

EXPERIMENTAL

Patients presenting periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography

Procedure: Extraction of mandibular molar

Without periapical granuloma

EXPERIMENTAL

Patients without periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography

Procedure: Extraction of mandibular molar

Interventions

Extraction of mandibular molar PROCEDURE

Patients who require extraction of mandibular molars will be submitted to surgery

With periapical granuloma; Without periapical granuloma

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients that need extraction of one or more dental elements, older than or equal to sixteen and less than sixty, will be included, obligatorily with local surgical and systemic need and opportunity. They should be literate, able to read and understand, with discernment and able to answer the survey questionnaire. The indication for extraction should be attributed to caries destruction, periodontal impairment, large trauma damage, root fractures, orthodontic indication, prosthetic / rehabilitative or presence of residual roots.

You may not qualify if:

• Patients over sixty, smokers, pregnant women, immunosuppressed, users of steroids, antidepressive and / or other psychiatric medications, users of illicit drugs, carriers of hemorrhagic disorders, with previous history of radiotherapy in the oral cavity, patients with metabolic and / or glandular bone disorders of chronic renal failure. Patients in whom the initial anesthesia does not install after a tube, without analgesia of part of the lip and tongue, or without numerical alteration in the pulp test, will also be excluded, characterizing failure in the anesthetic technique.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Serviço de Urgência da Faculdade de Odontologia de São Paulo

São Paulo, 05508000, Brazil

RECRUITING

Study Officials

• Bruno k Carrocini, Ms

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno K Carrocini, Ms

CONTACT

5511994331906; bruno.carrocini@usp.br

Ines A Buscariolo, PhD

CONTACT

5511982618190; iabuscar@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: June 1, 2017
• Primary Completion: October 30, 2018
• Study Completion: December 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-06

Locations

BR (1)