PainNCT03384160

Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Clinical Trial.

A study testing Group 1 -Pain monitor and Group 2 -Pain monitor in people with Pain and Teeth, Impacted, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The extraction of third molars, a frequent treatment in clinical dental practice, can lead patients to painful symptoms during and after surgery. The dental surgeon must correctly indicate the need for extraction and also provide patients who need this treatment greater comfort and control of pain in the trans and… Read more about this study

Who is it for?: Ages 16 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Teeth, Impacted
What is being tested?: Group 1 -Pain monitor and Group 2 -Pain monitor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteBrazil
Study dates: 7 Dec 2017to 4 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 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

American Society of Anesthesiologists Classification -(ASA I) patients;
Patients with need for extraction of lower third molars included and / or semi-included;
Teeth in opposing hemiarch with the same classifications as Pell and Gregory and Winter;
Age between 16 and 40 years;
Patients who agree to voluntarily participate in the survey.

Who cannot join

History of allergic reactions (hypersensitivity) to anesthetics;
Patients presenting with local or systemic alterations that contraindicate the procedure;
Current use of drugs that may interfere with the action of anesthetics;
Need for sedatives or anxiolytic drugs during extraction;
Pregnancy or breastfeeding;
Third erupted lower third molars.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Michelle Bianchi de Moraes
São José dos Campos, São Paulo, 12245000

Other trials in Brazil

About this study

Official title: Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Splint-mouth Randomized Double Blind Controlled Clinical Trial.

Read the detailed description

This study will compare the use of Articaine at 4% to that of Mepivacaine at 2% for lower third molar surgeries semi-included and / or included. I will select 16 patients who require surgical treatment for extraction of third molars, aged between 16 and 40 years at the São Paulo State University. These will participate simultaneously in the two groups: Group 1 mepivacaine (MEP) and Group 2 articaine (ART), and the division will be performed by randomization, so that each patient will have each side (right or left) allocated in different groups. The primary evaluation variable will be to compare the pain index in the immediate postoperative period, using Visual Analog Scale (VAS), and will also analyze Hemodynamic Parameters, such as Patient and Operator satisfaction. The results will be submitted to qualitative and quantitative statistical analysis. The descriptive data will be compared using the statistical analysis of variance (ANOVA) and Tukey test with a significance level of 5%.

Conditions: Pain, Teeth, Impacted
Being tested: Group 1 -Pain monitor, Group 2 -Pain monitor
Keywords: Pain, Third molar, Articaine, Mepivacaine
Medical subject headings: Pain, Tooth, Impacted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group 1 -Pain monitorDiagnostic test
Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative
Group 2 -Pain monitorDiagnostic test
Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative

Study groups in NCT03384160
Study group	Role	What they receive
Group 1-Pain monitor	Active comparator	Use of the anesthetic Mepivacaine 2% in third molar extraction Receives: Diagnostic Test: Group 2 -Pain monitor
Group 2 -Pain monitor	Active comparator	Use of the anesthetic Articaine 4% in third molar extraction Receives: Diagnostic Test: Group 1 -Pain monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain assessment
Evaluated in patients in groups 1 and 2. Scale of Visual Analog Scale (VAS), with values from zero to ten, being zero without pain and ten the maximum of pain. This scale will be provided on paper and divided into postoperative hours up to 3 days.
Measured: The scale will be provided on paper and divided into postoperative hours up to 3 days.

Secondary outcomes (1)

Assessment of blood pressure change
Evaluated in patients submitted to the exodontia of third molars, with different types of anesthetics.The investigator evaluated with auscultatory instrument.
Measured: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 20174 Dec 2018

First posted27 Dec 2017
Study start7 Dec 2017
Primary completion30 Oct 2018
Study completion4 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The sample will consist of 32 lower third molars, semi-inclusively or included. This study will be a randomized, double blind, controlled, split-mouth clinical trial, divided into two groups simultaneously, namely: Group 1 (16 teeth) - using anesthetic mepivacaine in third molar extraction. Group 2 (16 teeth) - using anesthetic articaine in third molar extraction
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03384160
Sponsor's protocol ID: ICT-UNESP
Status last verified: Feb 2019
First submitted: 17 Dec 2017
Last updated: 6 Feb 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Brockmann WG. Mepivacaine: a closer look at its properties and current utility. Gen Dent. 2014 Nov-Dec;62(6):70-5; quiz 76.
PubMed 25369391
Colombini BL, Modena KC, Calvo AM, Sakai VT, Giglio FP, Dionisio TJ, Trindade AS Jr, Lauris JR, Santos CF. Articaine and mepivacaine efficacy in postoperative analgesia for lower third molar removal: a double-blind, randomized, crossover study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Aug;102(2):169-74. doi: 10.1016/j.tripleo.2005.09.003. Epub 2006 Mar 24.
PubMed 16876058
Gregorio LV, Giglio FP, Sakai VT, Modena KC, Colombini BL, Calvo AM, Sipert CR, Dionisio TJ, Lauris JR, Faria FA, Trindade Junior AS, Santos CF. A comparison of the clinical anesthetic efficacy of 4% articaine and 0.5% bupivacaine (both with 1:200,000 epinephrine) for lower third molar removal. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jul;106(1):19-28. doi: 10.1016/j.tripleo.2007.11.024. Epub 2008 Apr 16.
PubMed 18420431
Holliday R, Jackson I. Superior position of the mandibular foramen and the necessary alterations in the local anaesthetic technique: a case report. Br Dent J. 2011 Mar 12;210(5):207-11. doi: 10.1038/sj.bdj.2011.145.
PubMed 21394145
McCoy JM. Complications of retention: pathology associated with retained third molars. Atlas Oral Maxillofac Surg Clin North Am. 2012 Sep;20(2):177-95. doi: 10.1016/j.cxom.2012.06.002. No abstract available.
PubMed 23021395

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Splint-mouth Randomized Double Blind Controlled Clinical Trial.
ClinicalTrials.gov ID: NCT03384160
Acronym / sponsor ID: ICT-UNESP
Conditions: Pain, Teeth, Impacted
Keywords: Pain, Third molar, Articaine, Mepivacaine
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
Collaborators: Prof. Dr. Fernando Vagner Raldi, Paula Carolina de Almeida
Study start: 7 Dec 2017 (actual)
Primary completion: 30 Oct 2018 (actual)
Study completion: 4 Dec 2018 (actual)
First posted: 27 Dec 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: The sample will consist of 32 lower third molars, semi-inclusively or included. This study will be a randomized, double blind, controlled, split-mouth clinical trial, divided into two groups simultaneously, namely: Group 1 (16 teeth) - using anesthetic mepivacaine in third molar extraction. Group 2 (16 teeth) - using anesthetic articaine in third molar extraction

Arm	Type	Receives
Group 1-Pain monitor	Active comparator	Diagnostic Test: Group 2 -Pain monitorUse of the anesthetic Mepivacaine 2% in third molar extraction
Group 2 -Pain monitor	Active comparator	Diagnostic Test: Group 1 -Pain monitorUse of the anesthetic Articaine 4% in third molar extraction

Who may qualify

Ages: 16 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

American Society of Anesthesiologists Classification -(ASA I) patients;
Patients with need for extraction of lower third molars included and / or semi-included;
Teeth in opposing hemiarch with the same classifications as Pell and Gregory and Winter;
Age between 16 and 40 years;
Patients who agree to voluntarily participate in the survey.

Key exclusion criteria (6 listed)

History of allergic reactions (hypersensitivity) to anesthetics;
Patients presenting with local or systemic alterations that contraindicate the procedure;
Current use of drugs that may interfere with the action of anesthetics;
Need for sedatives or anxiolytic drugs during extraction;
Pregnancy or breastfeeding;

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
Group 1 -Pain monitorUse of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative	Diagnostic test	Group 2 -Pain monitor
Group 2 -Pain monitorUse of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative	Diagnostic test	Group 1-Pain monitor

Primary outcome

Pain assessment
Time frame: The scale will be provided on paper and divided into postoperative hours up to 3 days.
Evaluated in patients in groups 1 and 2. Scale of Visual Analog Scale (VAS), with values from zero to ten, being zero without pain and ten the maximum of pain. This scale will be provided on paper and divided into postoperative hours up to 3 days.

1 secondary outcome

Assessment of blood pressure change
Time frame: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
Results publication: PubMed 25369391Brockmann WG. Mepivacaine: a closer look at its properties and current utility. Gen Dent. 2014 Nov-Dec;62(6):70-5; quiz 76.
Results publication: PubMed 16876058Colombini BL, Modena KC, Calvo AM, Sakai VT, Giglio FP, Dionisio TJ, Trindade AS Jr, Lauris JR, Santos CF. Articaine and mepivacaine efficacy in postoperative analgesia for lower third molar removal: a double-blind, randomized, crossover study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Aug;102(2):169-74. doi: 10.1016/j.tripleo.2005.09.003. Epub 2006 Mar 24.
Results publication: PubMed 18420431Gregorio LV, Giglio FP, Sakai VT, Modena KC, Colombini BL, Calvo AM, Sipert CR, Dionisio TJ, Lauris JR, Faria FA, Trindade Junior AS, Santos CF. A comparison of the clinical anesthetic efficacy of 4% articaine and 0.5% bupivacaine (both with 1:200,000 epinephrine) for lower third molar removal. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jul;106(1):19-28. doi: 10.1016/j.tripleo.2007.11.024. Epub 2008 Apr 16.
Results publication: PubMed 21394145Holliday R, Jackson I. Superior position of the mandibular foramen and the necessary alterations in the local anaesthetic technique: a case report. Br Dent J. 2011 Mar 12;210(5):207-11. doi: 10.1038/sj.bdj.2011.145.
Results publication: PubMed 23021395McCoy JM. Complications of retention: pathology associated with retained third molars. Atlas Oral Maxillofac Surg Clin North Am. 2012 Sep;20(2):177-95. doi: 10.1016/j.cxom.2012.06.002. No abstract available.
Individual participant dataSharing planned: No

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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.

Michelle B Moraes, PHD principal investigator

Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group 1 -Pain monitor and Group 2 -Pain monitor in people with Pain and Teeth, Impacted, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Feb 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain assessment (time frame: The scale will be provided on paper and divided into postoperative hours up to 3 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03384160, which also lists 5 linked publications.

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 6 Feb 2019.