Local AnestheticsNCT03106168
Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars
A study testing Extraction of mandibular molar in people with Local Anesthetics and Tooth Extraction, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthetics, Tooth Extraction
- What is being tested?
- Extraction of mandibular molar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Serviço de Urgência da Faculdade de Odontologia de São Paulo
São Paulo, 05508000
Ines Buscariolo, PhD, iabuscar@usp.br
Bruno K Carrocini, Ms, bruno.carrocini@usp.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Local Anesthetics, Tooth Extraction
- Being tested
- Extraction of mandibular molar
- Keywords
- Extraction, Local Anesthetic, Mepivacaine, Mandibular Molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of mandibular molarProcedure or surgery
Patients who require extraction of mandibular molars will be submitted to surgery
| Study group | Role | What they receive |
|---|---|---|
| With periapical granuloma | Experimental | Patients presenting periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography Receives: Procedure: Extraction of mandibular molar |
| Without periapical granuloma | Experimental | Patients without periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography Receives: Procedure: Extraction of mandibular molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic efficacy
The anesthetic efficacy will be analyzed through the use of a verbal numerical scale used during the pulpectomy procedure
Measured: 10 minutes after anesthetic technique
Secondary outcomes (2)
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
Measured: 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
Measured: seven days after the extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Jun 2017
- Primary completion30 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnestheticsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Klouczek Carrocini, University of Sao Paulo
- Investigators
- Bruno k Carrocini, Ms, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106168
- Sponsor's protocol ID
- Extraction
- Status last verified
- Jun 2018
- First submitted
- 4 Apr 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars With Periapical Granuloma
- ClinicalTrials.gov ID
- NCT03106168
- Acronym / sponsor ID
- Extraction
- Conditions
- Local Anesthetics, Tooth Extraction
- Keywords
- Extraction, Local Anesthetic, Mepivacaine, Mandibular Molar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With periapical granuloma | Experimental | Procedure: Extraction of mandibular molarPatients presenting periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography |
| Without periapical granuloma | Experimental | Procedure: Extraction of mandibular molarPatients without periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extraction of mandibular molarPatients who require extraction of mandibular molars will be submitted to surgery | Procedure or surgery | With periapical granuloma, Without periapical granuloma |
Primary outcome
Anesthetic efficacy
Time frame: 10 minutes after anesthetic technique
The anesthetic efficacy will be analyzed through the use of a verbal numerical scale used during the pulpectomy procedure
2 secondary outcomes
Pulpal Anesthesia
Time frame: 10 minutes after anesthetic technique
Postoperative pain
Time frame: seven days after the extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno k Carrocini, Ms principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction of mandibular molar in people with Local Anesthetics and Tooth Extraction, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno K Carrocini, Ms (5511994331906, bruno.carrocini@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic efficacy (time frame: 10 minutes after anesthetic technique). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.