Drug EffectPhase 4ECANCT04166890
Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia
A Phase 4 study testing Articaine / EPINEPHrine Cartridge in people with Drug Effect and Tooth Extraction, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
In the complexity of the Dental care the third molar surgery is one of the most common procedures, it is indicated for multiple reasons like infections in root canal, prosthetics or even esthetical purposes. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Effect, Tooth Extraction
- What is being tested?
- Articaine / EPINEPHrine Cartridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteColombia
- Study dates
- 4 Sep 2018to 30 Mar 2020
- Phase
- Phase 4
- 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 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, criteria assessed during anamnesis
- Age between 18 and 25 years old
- Presence of lower third molars in the mouth with no level of eruption determined by the clinical oral examination
- Weight / height ratio with a coefficient of variation of no more than 15% of the ideal weight, according to the tables of the Metropolitan Life Insurance
- Lower third molars in a mesio-angulated position evidenced by the panoramic radiography taken for the study in the Faculty of Dentistry of the University of Antioquia, and which is in Nolla's stage equal or greater than 6
- Voluntary acceptance to participate in the study by signing the informed consent
Who cannot join
- Presence of phobias or traumas related to the dental practice and/or with needles
- Presence of clinical problems such as kidney diseases, cardiovascular diseases, known allergies or drug hypersensitivity discovered through the anamnesis of the clinical history prepared for the investigation
- Hi consumption of alcohol or cigarettes
- Presence of problems related to drug dependence
- Being ill for the last two weeks before the study begins
- use of enzyme inhibitors or inducers for four weeks prior to the participation in the study
Show all 10Show fewer
- Have used any medication or natural product, seven days prior to the first part of the study
- Have donated blood in the last three months
- Have participated in another clinical trial, thirty days prior to the first part of the study
- Be a member of the research group or a relative of the responsible personnel involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia: Non-inferiority Trial
In the complexity of the Dental care the third molar surgery is one of the most common procedures, it is indicated for multiple reasons like infections in root canal, prosthetics or even esthetical purposes. This surgery can be safely performed with the help of local anesthetics, due to their quick action, and reversibility to control pain, reducing possible complications during and after the surgeries.
Among the different types of local anesthetics used in dentistry, the articaine bears characteristics that provide some advantages compared to similar anesthetics like Lidocaine, being one of the most used anesthetics worldwide. Different authors have concluded that it is a safe when used in patients at different ages and it is effective as a local anesthetic in the majority of procedures. It is important for dentists to know the differences or similarities of anesthetics in terms of their effects, safety, dosages required in patients undergoing surgical removal of teeth, as well as the mechanism of action and pharmacological properties, in order to take advantage of its benefits and minimize risks.
Read more
This study aims to test the efficacy and safety of an anesthetic solution, based on the same active molecule, articaine, manufactured by two different commercial houses, one domestic and one international, in order to gather scientific evidence and to show that they are not different. This will provide scientific results to help in the selection of any of these brands to be used with confidence in the dental practice. This will strengthen the collaboration between the academy and the companies, which would allow them to improve the quality of their products.
Locally there are no studies available comparing the articaine-type anesthetic with epinephrine at the same concentration, manufactured locally by a national company, to a foreign one, which is an important opportunity to expand the knowledge and create scientific reports, about what a local anesthetic is and what it does.
Finally, this study would contribute to the need to guarantee the quality of medicines in Colombia, by means of compliance with the legal provisions contemplated in resolution 1890 of November 2001 and 1400 of August 2001, issued by the Ministry of Health of Colombia : "Requirements to demonstrate the therapeutic effectiveness, through studies of Bioavailability and Bioequivalence of medicines for a special group of them.
Read the detailed description
Local anesthetic:
Local anesthetics are widely used in dentistry for different procedures and are chemical substances that block nerve conduction, temporarily and irreversibly in order to avoid pain and are placed in specific sites of the body, for example in oral tissues.
Pharmacology of local anesthetics related to effectiveness and safety
Latency time It is defined as the time that elapses between the infiltration of the anesthetic substance in the tissue until the first signs of insensibility are felt. It is influenced by the distance of the route the anesthetic must travel, with the ability to cross the membrane of the nerve cells.
Duration of the anesthetic effect Also known as the duration of the action, related to the capacity of fixation of the anesthetic substance to the nerve cell proteins and with lipid solubility.
pH of anesthetics It is one of the factors that influence the action of blocking nerve conduction, and is the factor that conditions the movement of the anesthetic from the site where it is administered to the nerve fiber, that is why the tissues that are infected make the effectiveness is decreased, since the pH would turn acidic. In addition, the pH varies according to whether or not it has a vasoconstrictor.
Power Anesthetic capacity to pass the lipids of the nerve membranes, the greater the liposolubility, the greater the anesthetic power, depending on how the power is the classification of the action time, low power with short action, intermediate power with action medium and high power with long action.
Diffusion It is related to the minimum concentration required to inhibit nerve conduction, given by the transfer of molecules or ions from an anesthetic solution from the point where it infiltrates to the membrane of the nerve cell.
Articaine
Articaine is a short-acting local anesthetic, belonging to the group of amides, it has an additional ester group that is rapidly hydrolyzed by plasma esterases, which exhibits a lower toxicity compared to other drugs of the same family. This dissolves better than other amides in the soft tissues and bone, for this reason, it is especially indicated for dental use.
Articaine is introduced in 1972 in the market of local anesthetics. Prepared for the first time by Rusching et al in 1969, it changed its generic name to articaine when it began to be used in clinical practice in Germany in 1976. Its use gradually expanded, until it entered the market of the United States and Canada, in 1983 and in the United Kingdom in 1998.
Articaine with vasoconstrictor (epinephrine) is administered submucosally. The onset of anesthetic effects is observed between 1 to 6 minutes and the duration of anesthesia is approximately one hour and is recommended for long procedures. After administration, maximum concentrations are reached after 20 minutes, approximately between 60 and 80% bind plasma proteins, in particular albumin and gamma globulins, and are easily distributed in soft tissues.
Its main metabolite is the articainic acid, which is metabolized by the isoenzymes of the cytochrome P450, between 5 and 10% of the articainic acid; this causes the increase of the elimination, half-life to 90 minutes. The drug is eliminated in the urine as articainic acid, as glucuronide of the articainic acid and as articaine without metabolizing.
The administration of vasoconstrictors such as epinephrine, together with an anesthetic, could cause increases in blood pressure or heart rate due to higher plasma levels, however, these adverse effects are uncommon.
Patients receiving local anesthesia for dental treatments may experience side effects at the level of the Central Nervous System (CNS), in case of receiving an intra-arterial injection with reflux into the cerebral circulation. Patients with peripheral vascular diseases and hypertension may experience an exaggerated response when treated with articaine-epinephrine due to the vasoconstrictive effects of epinephrine, which can be especially intense in the elderly.
Because of its bisulfite content (as a preservative of epinephrine), the preparations of articaine-epinephrine are contraindicated in patients with hypersensitivity to bisulfite. In addition, patients with asthma are usually more susceptible than others to this hypersensitivity.
There are few studies evaluating the pharmacokinetics of articaine in the elderly or in patients with renal or hepatic insufficiency, although caution is advised when administering articaine-epinephrine to patients with liver diseases, as these patients are more susceptible to the drug's potential toxicity and Dose reductions may be necessary. It should also be administered with caution in patients with a history of drug abuse because the adverse reactions are dose-related and in elderly patients should be dosed with the minimum effective dose.
- Conditions
- Drug Effect, Tooth Extraction
- Being tested
- Articaine / EPINEPHrine Cartridge
- Keywords
- Articaine, IANB, Third molar surgery, Non-inferiority, Local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine / EPINEPHrine CartridgeDrug
The day scheduled for the surgery, vital signs (pulse, blood pressure and oxygen saturation) will be recorded prior the administration of the anesthesia. A volume of 1.8 ml of 4% articaine and epinephrine 1: 100000 solution of either the test product or the reference product will be deposited slowly to proceed to the inferior alveolar nerve block (IANB), according to the table of allocation of treatments in each period. The vital signs will continue to be monitored during the procedure, and once the procedure has been completed. If the volunteer needs more anesthetic, this will be recorded and will be administrated according to the maximum permitted doses (7 mg / kg (up to 500 mg) 5 mg / kg in children 7), and immediately after the administration, the vital signs will be taken again.
| Study group | Role | What they receive |
|---|---|---|
| NS Lower right molar | Experimental | IANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000 Receives: Drug: Articaine / EPINEPHrine Cartridge |
| SD Lower Left molar | Active comparator | IANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000 Receives: Drug: Articaine / EPINEPHrine Cartridge |
| NS Lower left molar | Experimental | IANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000 Receives: Drug: Articaine / EPINEPHrine Cartridge |
| SD Lower right molar | Active comparator | IANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000 Receives: Drug: Articaine / EPINEPHrine Cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with total absence of sensitivity and pain
Assessment of total absence of tactile and pain sensitivity after administration of the anesthetics.
Measured: 2 to 8 minutes
Failure
Assessment of the inability to block tactile sensitivity or painful sensitivity
Measured: 10 minutes
Pain assessed by visual analogue pain scale
Monitoring of the visual analogue pain (VAS) scale, where the amount of pain patient feels ranges from 0, non pain to 10, extreme amount of pain.
Measured: One hour (1h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start4 Sep 2018
- Primary completion31 Jan 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Drug EffectStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open, randomized, double blind, controlled, phase 4 crossover, randomized clinical trial will be conducted to compare the efficacy and clinical safety of two homologous active principles, articaine HCl with 1: 100,000 epinephrine (test) against the reference formulation 4% articaine HCl with 1: 100,000 of epinephrine, used intraorally in extraction of retained third molars (18), and will be carried out in the Faculty of Dentistry of the University of Antioquia
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germán David Arboleda Toro, Universidad de Antioquia
- Investigators
- Fabian Jaimes, MD, PhD, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166890
- Sponsor's protocol ID
- Ensayo Clinico Articaina
- Acronym
- ECA
- Status last verified
- May 2021
- First submitted
- 8 Oct 2019
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim C, Hwang KG, Park CJ. Local anesthesia for mandibular third molar extraction. J Dent Anesth Pain Med. 2018 Oct;18(5):287-294. doi: 10.17245/jdapm.2018.18.5.287. Epub 2018 Oct 31.
PubMed 30402548Castañeda DA, Briceño CR, Sánchez AE, Rodrí- guez A, Castro D, Barrientos S. Prevalencia de dientes incluidos, retenidos e impactados analizados en radiografías panorámicas de población de Bogotá, Colombia. Univ Odontol. 2015 Jul-Dic; 34(73): 149-157. http://dx.doi.org/10.11144/ Javeriana.uo34-73.
Organización Mundial de la Salud (OMS). Marco Conceptual de la Clasificación Internacional para la Seguridad del Paciente. Ginebra: OMS; 2009.
Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.
PubMed 17175824Aggarwal V, Singla M, Miglani S, Kohli S. Efficacy of Articaine Versus Lidocaine Administered as Supplementary Intraligamentary Injection after a Failed Inferior Alveolar Nerve Block: A Randomized Double-blind Study. J Endod. 2019 Jan;45(1):1-5. doi: 10.1016/j.joen.2018.09.012. Epub 2018 Dec 6.
PubMed 30527595St George G, Morgan A, Meechan J, Moles DR, Needleman I, Ng YL, Petrie A. Injectable local anaesthetic agents for dental anaesthesia. Cochrane Database Syst Rev. 2018 Jul 10;7(7):CD006487. doi: 10.1002/14651858.CD006487.pub2.
PubMed 29990391Mittal J, Kaur G, Mann HS, Narang S, Kamra M, Kapoor S, Sindhi M, Kataria R. Comparative Study of the Efficacy of 4% Articaine vs 2% Lidocaine in Surgical Removal of Bilaterally Impacted Mandibular Third Molars. J Contemp Dent Pract. 2018 Jun 1;19(6):743-748.
PubMed 29959306Snoeck M. Articaine: a review of its use for local and regional anesthesia. Local Reg Anesth. 2012;5:23-33. doi: 10.2147/LRA.S16682. Epub 2012 Jun 5.
PubMed 22915899Bartlett G, Mansoor J. Articaine buccal infiltration vs lidocaine inferior dental block - a review of the literature. Br Dent J. 2016 Feb 12;220(3):117-20. doi: 10.1038/sj.bdj.2016.93.
PubMed 26868800Meechan JG. How to overcome failed local anaesthesia. Br Dent J. 1999 Jan 9;186(1):15-20. doi: 10.1038/sj.bdj.4800006.
PubMed 10028738Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.
PubMed 15966499Katyal V. The efficacy and safety of articaine versus lignocaine in dental treatments: a meta-analysis. J Dent. 2010 Apr;38(4):307-17. doi: 10.1016/j.jdent.2009.12.003. Epub 2009 Dec 16.
PubMed 20006669Malamed SF, Gagnon S, Leblanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc. 2000 May;131(5):635-42. doi: 10.14219/jada.archive.2000.0237.
PubMed 10832257Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
PubMed 21772732Hersh EV, Giannakopoulos H, Levin LM, Secreto S, Moore PA, Peterson C, Hutcheson M, Bouhajib M, Mosenkis A, Townsend RR. The pharmacokinetics and cardiovascular effects of high-dose articaine with 1:100,000 and 1:200,000 epinephrine. J Am Dent Assoc. 2006 Nov;137(11):1562-71. doi: 10.14219/jada.archive.2006.0092.
PubMed 17082283
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia: Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04166890
- Acronym / sponsor ID
- ECA / Ensayo Clinico Articaina
- Conditions
- Drug Effect, Tooth Extraction
- Keywords
- Articaine, IANB, Third molar surgery, Non-inferiority, Local anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Nov 2019 (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.
In the complexity of the Dental care the third molar surgery is one of the most common procedures, it is indicated for multiple reasons like infections in root canal, prosthetics or even esthetical purposes. This surgery can be safely performed with the help of local anesthetics, due to their quick action, and reversibility to control pain, reducing possible complications during and after the surgeries.
Among the different types of local anesthetics used in dentistry, the articaine bears characteristics that provide some advantages compared to similar anesthetics like Lidocaine, being one of the most used anesthetics worldwide. Different authors have concluded that it is a safe when used in patients at different ages and it is effective as a local anesthetic in the majority of procedures. It is important for dentists to know the differences or similarities of anesthetics in terms of their effects, safety, dosages required in patients undergoing surgical removal of teeth, as well as the mechanism of action and pharmacological properties, in order to take advantage of its benefits and minimize risks.
This study aims to test the efficacy and safety of an anesthetic solution, based on the same active molecule, articaine, manufactured by two different commercial houses, one domestic and one international, in order to gather scientific evidence and to show that they are not different. This will provide scientific results to help in the selection of any of these brands to be used with confidence in the dental practice. This will strengthen the collaboration between the academy and the companies, which would allow them to improve the quality of their products.
Locally there are no studies available comparing the articaine-type anesthetic with epinephrine at the same concentration, manufactured locally by a national company, to a foreign one, which is an important opportunity to expand the knowledge and create scientific reports, about what a local anesthetic is and what it does.
Finally, this study would contribute to the need to guarantee the quality of medicines in Colombia, by means of compliance with the legal provisions contemplated in resolution 1890 of November 2001 and 1400 of August 2001, issued by the Ministry of Health of Colombia : "Requirements to demonstrate the therapeutic effectiveness, through studies of Bioavailability and Bioequivalence of medicines for a special group of them.
Detailed description
Local anesthetic:
Local anesthetics are widely used in dentistry for different procedures and are chemical substances that block nerve conduction, temporarily and irreversibly in order to avoid pain and are placed in specific sites of the body, for example in oral tissues.
Pharmacology of local anesthetics related to effectiveness and safety
Latency time It is defined as the time that elapses between the infiltration of the anesthetic substance in the tissue until the first signs of insensibility are felt. It is influenced by the distance of the route the anesthetic must travel, with the ability to cross the membrane of the nerve cells.
Duration of the anesthetic effect Also known as the duration of the action, related to the capacity of fixation of the anesthetic substance to the nerve cell proteins and with lipid solubility.
pH of anesthetics It is one of the factors that influence the action of blocking nerve conduction, and is the factor that conditions the movement of the anesthetic from the site where it is administered to the nerve fiber, that is why the tissues that are infected make the effectiveness is decreased, since the pH would turn acidic. In addition, the pH varies according to whether or not it has a vasoconstrictor.
Power Anesthetic capacity to pass the lipids of the nerve membranes, the greater the liposolubility, the greater the anesthetic power, depending on how the power is the classification of the action time, low power with short action, intermediate power with action medium and high power with long action.
Diffusion It is related to the minimum concentration required to inhibit nerve conduction, given by the transfer of molecules or ions from an anesthetic solution from the point where it infiltrates to the membrane of the nerve cell.
Articaine
Articaine is a short-acting local anesthetic, belonging to the group of amides, it has an additional ester group that is rapidly hydrolyzed by plasma esterases, which exhibits a lower toxicity compared to other drugs of the same family. This dissolves better than other amides in the soft tissues and bone, for this reason, it is especially indicated for dental use.
Articaine is introduced in 1972 in the market of local anesthetics. Prepared for the first time by Rusching et al in 1969, it changed its generic name to articaine when it began to be used in clinical practice in Germany in 1976. Its use gradually expanded, until it entered the market of the United States and Canada, in 1983 and in the United Kingdom in 1998.
Articaine with vasoconstrictor (epinephrine) is administered submucosally. The onset of anesthetic effects is observed between 1 to 6 minutes and the duration of anesthesia is approximately one hour and is recommended for long procedures. After administration, maximum concentrations are reached after 20 minutes, approximately between 60 and 80% bind plasma proteins, in particular albumin and gamma globulins, and are easily distributed in soft tissues.
Its main metabolite is the articainic acid, which is metabolized by the isoenzymes of the cytochrome P450, between 5 and 10% of the articainic acid; this causes the increase of the elimination, half-life to 90 minutes. The drug is eliminated in the urine as articainic acid, as glucuronide of the articainic acid and as articaine without metabolizing.
The administration of vasoconstrictors such as epinephrine, together with an anesthetic, could cause increases in blood pressure or heart rate due to higher plasma levels, however, these adverse effects are uncommon.
Patients receiving local anesthesia for dental treatments may experience side effects at the level of the Central Nervous System (CNS), in case of receiving an intra-arterial injection with reflux into the cerebral circulation. Patients with peripheral vascular diseases and hypertension may experience an exaggerated response when treated with articaine-epinephrine due to the vasoconstrictive effects of epinephrine, which can be especially intense in the elderly.
Because of its bisulfite content (as a preservative of epinephrine), the preparations of articaine-epinephrine are contraindicated in patients with hypersensitivity to bisulfite. In addition, patients with asthma are usually more susceptible than others to this hypersensitivity.
There are few studies evaluating the pharmacokinetics of articaine in the elderly or in patients with renal or hepatic insufficiency, although caution is advised when administering articaine-epinephrine to patients with liver diseases, as these patients are more susceptible to the drug's potential toxicity and Dose reductions may be necessary. It should also be administered with caution in patients with a history of drug abuse because the adverse reactions are dose-related and in elderly patients should be dosed with the minimum effective dose.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Open, randomized, double blind, controlled, phase 4 crossover, randomized clinical trial will be conducted to compare the efficacy and clinical safety of two homologous active principles, articaine HCl with 1: 100,000 epinephrine (test) against the reference formulation 4% articaine HCl with 1: 100,000 of epinephrine, used intraorally in extraction of retained third molars (18), and will be carried out in the Faculty of Dentistry of the University of Antioquia
| Arm | Type | Receives |
|---|---|---|
| NS Lower right molar | Experimental | Drug: Articaine / EPINEPHrine CartridgeIANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000 |
| SD Lower Left molar | Active comparator | Drug: Articaine / EPINEPHrine CartridgeIANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000 |
| NS Lower left molar | Experimental | Drug: Articaine / EPINEPHrine CartridgeIANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000 |
| SD Lower right molar | Active comparator | Drug: Articaine / EPINEPHrine CartridgeIANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000 |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy men and women, criteria assessed during anamnesis
- Age between 18 and 25 years old
- Presence of lower third molars in the mouth with no level of eruption determined by the clinical oral examination
- Weight / height ratio with a coefficient of variation of no more than 15% of the ideal weight, according to the tables of the Metropolitan Life Insurance
- Lower third molars in a mesio-angulated position evidenced by the panoramic radiography taken for the study in the Faculty of Dentistry of the University of Antioquia, and which is in Nolla's stage equal or greater than 6
Key exclusion criteria (10 listed)
- Presence of phobias or traumas related to the dental practice and/or with needles
- Presence of clinical problems such as kidney diseases, cardiovascular diseases, known allergies or drug hypersensitivity discovered through the anamnesis of the clinical history prepared for the investigation
- Hi consumption of alcohol or cigarettes
- Presence of problems related to drug dependence
- Being ill for the last two weeks before the study begins
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 |
|---|---|---|
| Articaine / EPINEPHrine CartridgeThe day scheduled for the surgery, vital signs (pulse, blood pressure and oxygen saturation) will be recorded prior the administration of the anesthesia. A volume of 1.8 ml of 4% articaine and epinephrine 1: 100000 solution of either the test product or the reference product will be deposited slowly to proceed to the inferior alveolar nerve block (IANB), according to the table of allocation of treatments in each period. The vital signs will continue to be monitored during the procedure, and once the procedure has been completed. If the volunteer needs more anesthetic, this will be recorded and will be administrated according to the maximum permitted doses (7 mg / kg (up to 500 mg) 5 mg / kg in children 7), and immediately after the administration, the vital signs will be taken again. | Drug | NS Lower left molar, NS Lower right molar, SD Lower Left molar, SD Lower right molar |
Primary outcome
Number of patients with total absence of sensitivity and pain
Time frame: 2 to 8 minutes
Assessment of total absence of tactile and pain sensitivity after administration of the anesthetics.
Failure
Time frame: 10 minutes
Assessment of the inability to block tactile sensitivity or painful sensitivity
Pain assessed by visual analogue pain scale
Time frame: One hour (1h)
Monitoring of the visual analogue pain (VAS) scale, where the amount of pain patient feels ranges from 0, non pain to 10, extreme amount of pain.
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 12 May 2021.
- Background: PubMed 30402548Kim C, Hwang KG, Park CJ. Local anesthesia for mandibular third molar extraction. J Dent Anesth Pain Med. 2018 Oct;18(5):287-294. doi: 10.17245/jdapm.2018.18.5.287. Epub 2018 Oct 31.
- BackgroundCastañeda DA, Briceño CR, Sánchez AE, Rodrí- guez A, Castro D, Barrientos S. Prevalencia de dientes incluidos, retenidos e impactados analizados en radiografías panorámicas de población de Bogotá, Colombia. Univ Odontol. 2015 Jul-Dic; 34(73): 149-157. http://dx.doi.org/10.11144/ Javeriana.uo34-73.
- BackgroundOrganización Mundial de la Salud (OMS). Marco Conceptual de la Clasificación Internacional para la Seguridad del Paciente. Ginebra: OMS; 2009.
- Background: PubMed 17175824Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.
- Background: PubMed 30527595Aggarwal V, Singla M, Miglani S, Kohli S. Efficacy of Articaine Versus Lidocaine Administered as Supplementary Intraligamentary Injection after a Failed Inferior Alveolar Nerve Block: A Randomized Double-blind Study. J Endod. 2019 Jan;45(1):1-5. doi: 10.1016/j.joen.2018.09.012. Epub 2018 Dec 6.
- Background: PubMed 29990391St George G, Morgan A, Meechan J, Moles DR, Needleman I, Ng YL, Petrie A. Injectable local anaesthetic agents for dental anaesthesia. Cochrane Database Syst Rev. 2018 Jul 10;7(7):CD006487. doi: 10.1002/14651858.CD006487.pub2.
- Background: PubMed 29959306Mittal J, Kaur G, Mann HS, Narang S, Kamra M, Kapoor S, Sindhi M, Kataria R. Comparative Study of the Efficacy of 4% Articaine vs 2% Lidocaine in Surgical Removal of Bilaterally Impacted Mandibular Third Molars. J Contemp Dent Pract. 2018 Jun 1;19(6):743-748.
- Results publication: PubMed 22915899Snoeck M. Articaine: a review of its use for local and regional anesthesia. Local Reg Anesth. 2012;5:23-33. doi: 10.2147/LRA.S16682. Epub 2012 Jun 5.
- Results publication: PubMed 26868800Bartlett G, Mansoor J. Articaine buccal infiltration vs lidocaine inferior dental block - a review of the literature. Br Dent J. 2016 Feb 12;220(3):117-20. doi: 10.1038/sj.bdj.2016.93.
- Results publication: PubMed 10028738Meechan JG. How to overcome failed local anaesthesia. Br Dent J. 1999 Jan 9;186(1):15-20. doi: 10.1038/sj.bdj.4800006.
- Results publication: PubMed 15966499Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.
- Results publication: PubMed 20006669Katyal V. The efficacy and safety of articaine versus lignocaine in dental treatments: a meta-analysis. J Dent. 2010 Apr;38(4):307-17. doi: 10.1016/j.jdent.2009.12.003. Epub 2009 Dec 16.
- 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.
Fabian Jaimes, MD, PhD study director
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Articaine / EPINEPHrine Cartridge in people with Drug Effect and Tooth Extraction, run by Universidad de Antioquia at 1 site in Colombia.
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 6 inclusion and 10 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 12 May 2021. 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 Colombia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients with total absence of sensitivity and pain (time frame: 2 to 8 minutes). The study lists 3 primary outcomes in all. 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 NCT04166890, which also lists 18 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 12 May 2021.