ChannelopathiesSLDAPCCNCT03182777
Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
A study testing Dental restorative procedure in people with Channelopathies and Brugada Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Patients with cardiac channelopathies needing restorative dental treatment will be included in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL) will be evaluated. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Channelopathies, Brugada Syndrome, Long QT Syndrome
- What is being tested?
- Dental restorative procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Aug 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with any channelopathies below, kept on optimal drug therapy, with or without ICD:
- Brugada Syndrome, Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia
- Dental caries or unsatisfactory restorations in the mandible, indicating restorative dental treatment
Who cannot join
- Patients allergic to lidocaine
- Patients undergoing ICD therapy for less than three months
- Patients with recurrent syncope in the last three months
- Patients with sustained arrhythmias documented for less than 3 months
- Have received epinephrine in the last 24 hours
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403000
About this study
Patients with cardiac channelopathies needing restorative dental treatment will be included in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL) will be evaluated. The patients will be their own control and will be assessed by Holter monitoring for 28 hours, blood pressure measurement and anxiety measuring.
Read the detailed description
Patients of Heart Institute of the University of São Paulo with inherited cardiac channelopathies will be included, considering the criteria for inclusion and non-inclusion, after reading and signing the informed consent.
They will undergo dental restorative treatment in two sessions, in the morning period, with an interval of at least seven days (wash-out) between them, and the patients will be their own control.
In the first session, after randomization, patients will receive lidocaine 2% without vasoconstrictor (LSA) or lidocaine 2% with 1: 100,000 epinephrine (LCA) (cross-over), resulting in two conditions: with adrenaline and without adrenaline.
The randomization of the anesthetic solution will be performed by the main researcher, being blind to the performer researcher and to the patient.
The injected volume will be 3.6 mL (2 cartridges) of the anesthetic solution, using blocking technique of the inferior alveolar nerve.
The patients will be monitored by Holter for 28 hours starting one hour before the procedure, for registration and analysis of cardiac electrical activity during the two sessions. Blood pressure will be monitored with digital sphygmomanometer and anxiety will be measured with Facial Image Scale, both on three occasions: at the beginning of the baseline periods, before starting application of anesthesia and at the end of the proceedings. The results will be analyzed statistically.
- Being tested
- Dental restorative procedure
- Keywords
- arrhythmias, cardiac, channelopathies, death, sudden, genetic testing, electrocardiography, ambulatory, anesthesia, local, dentistry
- Medical subject headings
- Channelopathies, Brugada Syndrome, Long QT Syndrome, Tachycardia, Ventricular, Arrhythmias, Cardiac, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental restorative procedureProcedure or surgery
Infiltration of two cartridges (3.6 mL) of local anesthetics with 2% lidocaine with or without epinephrine 1:100,000, in two sessions with an interval of seven days between them, in oral mucosa in patients with cardiac channelopathies.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine with epinephrine | Active comparator | Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% with epinephrine 1:100.000 for dental restorative procedures in patients with cardiac channelopathies. Receives: Procedure: Dental restorative procedure |
| Lidocaine | Active comparator | Application of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% without vasoconstrictor for dental restorative procedures in patients with cardiac channelopathies. Receives: Procedure: Dental restorative procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
No sustained ventricular tachycardia
No life-threatening arrhythmias and clinical signs and symptoms
Measured: during dental procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startMay 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for ChannelopathiesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital
- Investigators
- Itamara LI Neves, PhD, Principal investigator, Instituto do Coração do HCFMUSPAna CG Oliveira, S, Study chair, Instituto do Coração do HCFMUSPRicardo S Neves, PhD, Study director, Instituto do Coração do HCFMUSPLuciana Sacilotto, S, Study chair, Instituto do Coração do HCFMUSPFrancisco CC Darrieux, PhD, Study chair, Instituto do Coração do HCFMUSPMaurício I Scanavacca, PhD, Study director, Instituto do Coração do HCFMUSPDenise Hachul, PhD, Study chair, Instituto do Coração do HCFMUSPCesar J Gruppi, PhD, Study director, Instituto do Coração do HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182777
- Sponsor's protocol ID
- Odonto-Canalopatias
- Acronym
- SLDAPCC
- Status last verified
- Apr 2024
- First submitted
- 15 Oct 2015
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After thesis defense, the IPD will be available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo (http://www.teses.usp.br/index.php?option=com\_jumi\&fileid=12\&Itemid=77\&lang=pt-br), in a PDF file.
Publications
Amin AS, Asghari-Roodsari A, Tan HL. Cardiac sodium channelopathies. Pflugers Arch. 2010 Jul;460(2):223-37. doi: 10.1007/s00424-009-0761-0. Epub 2009 Nov 29.
PubMed 20091048Kauferstein S, Kiehne N, Neumann T, Pitschner HF, Bratzke H. Cardiac gene defects can cause sudden cardiac death in young people. Dtsch Arztebl Int. 2009 Jan;106(4):41-7. doi: 10.3238/arztebl.2009.0041. Epub 2009 Jan 23.
PubMed 19564966Perusse R, Goulet JP, Turcotte JY. Contraindications to vasoconstrictors in dentistry: Part I. Cardiovascular diseases. Oral Surg Oral Med Oral Pathol. 1992 Nov;74(5):679-86. doi: 10.1016/0030-4220(92)90365-w.
PubMed 1437073Groban L, Deal DD, Vernon JC, James RL, Butterworth J. Ventricular arrhythmias with or without programmed electrical stimulation after incremental overdosage with lidocaine, bupivacaine, levobupivacaine, and ropivacaine. Anesth Analg. 2000 Nov;91(5):1103-11. doi: 10.1097/00000539-200011000-00011.
PubMed 11049891Jowett NI, Cabot LB. Patients with cardiac disease: considerations for the dental practitioner. Br Dent J. 2000 Sep 23;189(6):297-302. doi: 10.1038/sj.bdj.4800750.
PubMed 11060950Rochford C, Seldin RD. Review and management of the dental patient with Long QT syndrome (LQTS). Anesth Prog. 2009 Summer;56(2):42-8. doi: 10.2344/0003-3006-56.2.42.
PubMed 19642718Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002 Jan;12(1):47-52.
PubMed 11853248Naftalin LW, Yagiela JA. Vasoconstrictors: indications and precautions. Dent Clin North Am. 2002 Oct;46(4):733-46, ix. doi: 10.1016/s0011-8532(02)00021-6.
PubMed 12436828Pallasch TJ. Vasoconstrictors and the heart. J Calif Dent Assoc. 1998 Sep;26(9):668-73, 676.
PubMed 9879236Finder RL, Moore PA. Adverse drug reactions to local anesthesia. Dent Clin North Am. 2002 Oct;46(4):747-57, x. doi: 10.1016/s0011-8532(02)00018-6.
PubMed 12436829Goulet JP, Perusse R, Turcotte JY. Contraindications to vasoconstrictors in dentistry: Part III. Pharmacologic interactions. Oral Surg Oral Med Oral Pathol. 1992 Nov;74(5):692-7. doi: 10.1016/0030-4220(92)90367-y.
PubMed 1359489Brown RS, Rhodus NL. Epinephrine and local anesthesia revisited. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Oct;100(4):401-8. doi: 10.1016/j.tripleo.2005.05.074. No abstract available.
PubMed 16182160Hersh EV, Giannakopoulos H. Beta-adrenergic blocking agents and dental vasoconstrictors. Dent Clin North Am. 2010 Oct;54(4):687-96. doi: 10.1016/j.cden.2010.06.009.
PubMed 20831932Neves RS, Neves IL, Giorgi DM, Grupi CJ, Cesar LA, Hueb W, Grinberg M. Effects of epinephrine in local dental anesthesia in patients with coronary artery disease. Arq Bras Cardiol. 2007 May;88(5):545-51. doi: 10.1590/s0066-782x2007000500008. English, Portuguese.
PubMed 17589629Yagiela JA. Adverse drug interactions in dental practice: interactions associated with vasoconstrictors. Part V of a series. J Am Dent Assoc. 1999 May;130(5):701-9. doi: 10.14219/jada.archive.1999.0280.
PubMed 10332135
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
- ClinicalTrials.gov ID
- NCT03182777
- Acronym / sponsor ID
- SLDAPCC / Odonto-Canalopatias
- Keywords
- arrhythmias, cardiac, channelopathies, death, sudden, genetic testing, electrocardiography, ambulatory, anesthesia, local, dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 9 Jun 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.
Patients with cardiac channelopathies needing restorative dental treatment will be included in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL) will be evaluated. The patients will be their own control and will be assessed by Holter monitoring for 28 hours, blood pressure measurement and anxiety measuring.
Detailed description
Patients of Heart Institute of the University of São Paulo with inherited cardiac channelopathies will be included, considering the criteria for inclusion and non-inclusion, after reading and signing the informed consent.
They will undergo dental restorative treatment in two sessions, in the morning period, with an interval of at least seven days (wash-out) between them, and the patients will be their own control.
In the first session, after randomization, patients will receive lidocaine 2% without vasoconstrictor (LSA) or lidocaine 2% with 1: 100,000 epinephrine (LCA) (cross-over), resulting in two conditions: with adrenaline and without adrenaline.
The randomization of the anesthetic solution will be performed by the main researcher, being blind to the performer researcher and to the patient.
The injected volume will be 3.6 mL (2 cartridges) of the anesthetic solution, using blocking technique of the inferior alveolar nerve.
The patients will be monitored by Holter for 28 hours starting one hour before the procedure, for registration and analysis of cardiac electrical activity during the two sessions. Blood pressure will be monitored with digital sphygmomanometer and anxiety will be measured with Facial Image Scale, both on three occasions: at the beginning of the baseline periods, before starting application of anesthesia and at the end of the proceedings. The results will be analyzed statistically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine with epinephrine | Active comparator | Procedure: Dental restorative procedureApplication of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% with epinephrine 1:100.000 for dental restorative procedures in patients with cardiac channelopathies. |
| Lidocaine | Active comparator | Procedure: Dental restorative procedureApplication of local dental anesthesia with two cartridges (3,6 mL) of lidocaine 2% without vasoconstrictor for dental restorative procedures in patients with cardiac channelopathies. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with any channelopathies below, kept on optimal drug therapy, with or without ICD:
- Brugada Syndrome, Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia
- Dental caries or unsatisfactory restorations in the mandible, indicating restorative dental treatment
Key exclusion criteria (5 listed)
- Patients allergic to lidocaine
- Patients undergoing ICD therapy for less than three months
- Patients with recurrent syncope in the last three months
- Patients with sustained arrhythmias documented for less than 3 months
- Have received epinephrine in the last 24 hours
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 |
|---|---|---|
| Dental restorative procedureInfiltration of two cartridges (3.6 mL) of local anesthetics with 2% lidocaine with or without epinephrine 1:100,000, in two sessions with an interval of seven days between them, in oral mucosa in patients with cardiac channelopathies. | Procedure or surgery | Lidocaine, Lidocaine with epinephrine |
Primary outcome
No sustained ventricular tachycardia
Time frame: during dental procedures
No life-threatening arrhythmias and clinical signs and symptoms
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 9 Apr 2024.
- Background: PubMed 20091048Amin AS, Asghari-Roodsari A, Tan HL. Cardiac sodium channelopathies. Pflugers Arch. 2010 Jul;460(2):223-37. doi: 10.1007/s00424-009-0761-0. Epub 2009 Nov 29.
- Background: PubMed 19564966Kauferstein S, Kiehne N, Neumann T, Pitschner HF, Bratzke H. Cardiac gene defects can cause sudden cardiac death in young people. Dtsch Arztebl Int. 2009 Jan;106(4):41-7. doi: 10.3238/arztebl.2009.0041. Epub 2009 Jan 23.
- Background: PubMed 1437073Perusse R, Goulet JP, Turcotte JY. Contraindications to vasoconstrictors in dentistry: Part I. Cardiovascular diseases. Oral Surg Oral Med Oral Pathol. 1992 Nov;74(5):679-86. doi: 10.1016/0030-4220(92)90365-w.
- Background: PubMed 11049891Groban L, Deal DD, Vernon JC, James RL, Butterworth J. Ventricular arrhythmias with or without programmed electrical stimulation after incremental overdosage with lidocaine, bupivacaine, levobupivacaine, and ropivacaine. Anesth Analg. 2000 Nov;91(5):1103-11. doi: 10.1097/00000539-200011000-00011.
- Background: PubMed 11060950Jowett NI, Cabot LB. Patients with cardiac disease: considerations for the dental practitioner. Br Dent J. 2000 Sep 23;189(6):297-302. doi: 10.1038/sj.bdj.4800750.
- Background: PubMed 19642718Rochford C, Seldin RD. Review and management of the dental patient with Long QT syndrome (LQTS). Anesth Prog. 2009 Summer;56(2):42-8. doi: 10.2344/0003-3006-56.2.42.
- Background: PubMed 11853248Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002 Jan;12(1):47-52.
- Background: PubMed 12436828Naftalin LW, Yagiela JA. Vasoconstrictors: indications and precautions. Dent Clin North Am. 2002 Oct;46(4):733-46, ix. doi: 10.1016/s0011-8532(02)00021-6.
- Background: PubMed 9879236Pallasch TJ. Vasoconstrictors and the heart. J Calif Dent Assoc. 1998 Sep;26(9):668-73, 676.
- Background: PubMed 12436829Finder RL, Moore PA. Adverse drug reactions to local anesthesia. Dent Clin North Am. 2002 Oct;46(4):747-57, x. doi: 10.1016/s0011-8532(02)00018-6.
- Background: PubMed 1359489Goulet JP, Perusse R, Turcotte JY. Contraindications to vasoconstrictors in dentistry: Part III. Pharmacologic interactions. Oral Surg Oral Med Oral Pathol. 1992 Nov;74(5):692-7. doi: 10.1016/0030-4220(92)90367-y.
- Background: PubMed 16182160Brown RS, Rhodus NL. Epinephrine and local anesthesia revisited. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Oct;100(4):401-8. doi: 10.1016/j.tripleo.2005.05.074. No abstract available.
- Individual participant dataSharing planned: Yes. After thesis defense, the IPD will be available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo (http://www.teses.usp.br/index.php?option=com_jumi\&fileid=12\&Itemid=77\&lang=pt-br), in a PDF file.
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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.
Itamara LI Neves, PhD principal investigator
Instituto do Coração do HCFMUSP
Ana CG Oliveira, S study chair
Instituto do Coração do HCFMUSP
Ricardo S Neves, PhD study director
Instituto do Coração do HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental restorative procedure in people with Channelopathies and Brugada Syndrome, run by University of Sao Paulo General Hospital 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 3 inclusion and 5 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 9 Apr 2024. 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?
No sustained ventricular tachycardia (time frame: during dental procedures). 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 NCT03182777, which also lists 25 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 9 Apr 2024.