Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03106168
• Other study ID #: Extraction
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2018
• Source: University of Sao Paulo
• Contact: Bruno K Carrocini, Ms
• Phone: 5511994331906
• Email: bruno.carrocini[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Local Anesthetics
• Tooth Extraction

Intervention

Procedure:
• Extraction of mandibular molar
Patients who require extraction of mandibular molars will be submitted to surgery

Locations

Country	Name	City	State
Brazil	Serviço de Urgência da Faculdade de Odontologia de 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
Primary	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	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
Secondary	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