Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars

Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars With Periapical Granuloma

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.

Study Overview

• Status: Unknown
• Conditions: Tooth Extraction; Local Anesthetics
• Intervention / Treatment: Procedure: Extraction of mandibular molar

Detailed Description

Anamnesis and clinical diagnosis of patients, with indication of extraction, will be performed by the Emergency Department of the School of Dentistry of the University of São Paulo (SDUSP). Of these, 80 patients with mandibular molar teeth extraction, with and without apparent apical lesion radiographically identified in the initial imaging examination will be included. They must be over 16 years old, with good judgment and good general health, who have availability of return to the clinic for postoperative follow-up and aware of the Term of Consent.

After the anamnesis, clinical and radiographic examinations for diagnosis and inclusion in the study, they will receive information on the procedure to be submitted, mainly on the quality of the local anesthetic block, quantification of pain and / or discomfort, and what will occur on the days after the procedure, such as guidelines and post-operative care (PO).

The clinical procedure (extraction) will follow the protocol of attendance of the Emergency Department of SDUSP, which is consistent with the surgical practice in force in this School and in other Dentistry Schools. In clinical care, patients will be questioned about the presence of discomfort and / or pain, indicated on the visual analogue scale (VAS score 0, score 1, score 2 or pain score 3). They will be informed about the effects of anesthesia, the use of the pulptest sensitivity test, absence of sensitivity in soft tissue and pulp after anesthesia, and the need for complementation with more local anesthetic (Mepivacaine and Noradrenaline) and / or incorporation of other anesthetic techniques.

To obtain basal tooth responsiveness patterns, prior to anesthesia, the pulptest will be applied to vital teeth of the quadrant that will receive intervention. The same will be reapplied after the injection of the anesthetic, in order to verify the installation of the blockade. Only after the anesthetic blockade has been confirmed and installed, both pulp ("Pulptest"), and soft tissues, the patient will be included in the research, initiating the surgical procedure. Any discomfort or complaint that the patient may have during the transoperatory period will be considered and, if necessary, we will use anesthetic complementation, which is recorded. In the postoperative period, these patients will have the opportunity to report some discomfort and pain, through a questionnaire, which will be filled and returned on the day of removal of suture, as well as intercurrence and / or need to use the suggested medication in case of pain.

The information obtained in this study will be inserted in Excel spreadsheet for descriptive analysis, statistics and comparison.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05508000
    • Recruiting
    • Serviço de Urgência da Faculdade de Odontologia de São Paulo
    • Contact: Ines Buscariolo, PhD; Email: iabuscar@usp.br
    • Contact: Bruno K Carrocini, Ms; Email: bruno.carrocini@usp.br
    • Principal Investigator: Bruno K Carrocini, Ms

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: With periapical granuloma; Patients presenting periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography	Procedure: Extraction of mandibular molar; Patients who require extraction of mandibular molars will be submitted to surgery
EXPERIMENTAL: Without periapical granuloma; Patients without periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography	Procedure: Extraction of mandibular molar; Patients who require extraction of mandibular molars will be submitted to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulpal Anesthesia	Pulp anesthesia was defined as the absence of a positive response to the Pulptest after 10 minutes of the inferior alveolar nerve block in the teeth adjacent to the one selected for extraction	10 minutes after anesthetic technique
Postoperative pain	A postoperative evaluation of pain and discomfort was carried out by the patient in the first seven days after the surgery through the analysis of a questionnaire	seven days after the extraction

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Bruno k Carrocini, Ms, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ANTICIPATED): October 30, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Local Anesthetic; Mepivacaine; Extraction; Mandibular Molar
• Other Study ID Numbers: Extraction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No