Tooth Extraction Status NosNCT06644950
Efficacy and Safety of Administration of Different Doses of 4% Articaine.
A study testing Efficacy and safety of administering 1 or two cartridges of anesthesia in people with Tooth Extraction Status Nos and Anesthesia, Local, run by University of Barcelona at 1 site in Spain.
Trial summary
The goal of this triple-blind randomized clinical trial is to compare the efficacy and safety of administering one cartridge (1.8 mL) versus two cartridges of articaine 4% with epinephrine 1:100,000 for lower third molar extraction using the inferior alveolar nerve block technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Status Nos, Anesthesia, Local
- What is being tested?
- Efficacy and safety of administering 1 or two cartridges of anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2023to 2 Oct 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of legal age (≥18 years) requiring surgical extraction of a lower wisdom tooth (whether erupted, semi-erupted or included).
- Patients without relevant systemic pathology (equal or lower than ASA II).
- Sufficient intellectual capacity to understand the study, the informed consent and to adequately complete the questionnaires.
Who cannot join
- Pregnant patients.
- Patients with hypersensitivity to articaine or adrenaline.
- Patients with uncontrolled systemic diseases.
- Drugs or systemic diseases (ASA III or higher) and that contraindicate a surgical intervention or the use of anesthetics and/or vasoconstrictors.
- Patients with relative or absolute contraindication of conventional analgesic or anti-inflammatory regimen.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontológic de Barcelona
L'Hospitalet de Llobregat, Barcelona
About this study
Official title: Efficacy and Safety of Administration of Different Doses of 4% Articaine (1:100,000 Epinephrine) Using the Lower Dental Nerve Block Technique for Lower Third Molar Extraction. A Triple-blind Randomized Clinical Trial.
The goal of this triple-blind randomized clinical trial is to compare the efficacy and safety of administering one cartridge (1.8 mL) versus two cartridges of articaine 4% with epinephrine 1:100,000 for lower third molar extraction using the inferior alveolar nerve block technique.
The main questions it aims to answer are:
Read more
- The injection of 3.6 ml of 4% articaine 1:100,000 has a higher anesthetic efficacy than a single injection of 1.8 ml of the same anesthetic.
- The injection of 3.6 ml of 4% articaine 1:100,000 has a higher rate of adverse effects than a single injection of 1.8 ml of the same anesthetic.
- The injection of 3.6 ml of 4% articaine 1:100,000 has a greater alteration of heart rate, oxygen saturation and systolic and diastolic blood pressure than a single injection of 1.8 ml of the same anesthetic.
The investigator (XA) will perform the anesthetic technique.
- The investigator will administer a first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened.
- In the control group, a single cartridge of anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds.
- In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.
- After checking Vincent's sign, the vestibular (buccal nerve) infiltration will be performed in both groups with half a cartridge (0.9 ml) of the same anesthetic solution.
- The latency of the anesthetic effect will be measured using a pulpometer.
- Subsequently, a student of the Master's Degree in Oral Surgery of the University of Barcelona will perform the surgical intervention. The surgeons in charge of performing the extraction will not know to which group each patient belongs.
- The collection of the variables and the postoperative controls will be carried out by the researcher who has not performed the anesthetic technique and who will not know the study group to which the patient belongs.
- Conditions
- Tooth Extraction Status Nos, Anesthesia, Local
- Being tested
- Efficacy and safety of administering 1 or two cartridges of anesthesia
- Keywords
- anesthesia, block nerve, wisdom tooth, wisdom tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy and safety of administering 1 or two cartridges of anesthesiaOther
The investigator will administer the first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened.
In the control group, only the first anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds.
In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Two cartridges of anesthetic | Experimental | Two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block. Receives: Other: Efficacy and safety of administering 1 or two cartridges of anesthesia |
| Single cartridge of anesthetic | Active comparator | In the control group, a single cartridge of anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without needle, in the same area, counting up to 30 seconds. Receives: Other: Efficacy and safety of administering 1 or two cartridges of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of administering one or two cartridges of articaine 4% with epinephrine 1:100,000 using the direct approach of the lower dental nerve block
Determined by:
- Achieving Vincent's sign within 6 minutes after injection.
- Reporting a negative response to the pulpometer within 6 minutes after injection.
- Absence of need for reanesthesia during the surgical procedure.
Measured: 1 hour
Secondary outcomes (2)
To compare the safety of both techniques
Determined by the appearance or absence of adverse effects, such as : Disorientation, dizziness, blurred vision, nausea, vomiting, tremors, convulsions, vasovagal syncope, paresthesia or trismus.
Measured: 7 days
Determine the hemodynamic changes that occur during surgery.
Determined by the changes between the preoperative measurements and the postoperatives.
Measured: 1 to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start25 May 2023
- Primary completion25 May 2024
- Study completion2 Oct 2024
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 Tooth Extraction Status NosStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrià Jorba García, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644950
- Sponsor's protocol ID
- 28/2022
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Duarte-Rodrigues L, Miranda EFP, Souza TO, de Paiva HN, Falci SGM, Galvao EL. Third molar removal and its impact on quality of life: systematic review and meta-analysis. Qual Life Res. 2018 Oct;27(10):2477-2489. doi: 10.1007/s11136-018-1889-1. Epub 2018 May 24.
PubMed 29797177Ku JK, Kim JY, Jun MK, Jeong YK, Huh JK. Influence of General and Local Anesthesia on Postoperative Pain after Impacted Third Molar Surgery. J Clin Med. 2021 Jun 17;10(12):2674. doi: 10.3390/jcm10122674.
PubMed 34204470Sainz de Baranda B, Silvestre FJ, Silvestre-Rangil J. Relationship Between Surgical Difficulty of Third Molar Extraction Under Local Anesthesia and the Postoperative Evolution of Clinical and Blood Parameters. J Oral Maxillofac Surg. 2019 Jul;77(7):1337-1345. doi: 10.1016/j.joms.2019.02.020. Epub 2019 Feb 20.
PubMed 30878593Olmedo-Gaya MV, Manzano-Moreno FJ, Munoz-Lopez JL, Vallecillo-Capilla MF, Reyes-Botella C. Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction. Clin Oral Investig. 2018 Dec;22(9):2981-2988. doi: 10.1007/s00784-018-2386-1. Epub 2018 Feb 15.
PubMed 29450738Camps-Font O, Figueiredo R, Sanchez-Torres A, Cle-Ovejero A, Coulthard P, Gay-Escoda C, Valmaseda-Castellon E. Which is the most suitable local anaesthetic when inferior nerve blocks are used for impacted mandibular third molar extraction? A network meta-analysis. Int J Oral Maxillofac Surg. 2020 Nov;49(11):1497-1507. doi: 10.1016/j.ijom.2020.04.016. Epub 2020 May 27.
PubMed 32473767Santos-Sanz L, Toledano-Serrabona J, Gay-Escoda C. Safety and efficacy of 4% articaine in mandibular third-molar extraction: A systematic review and meta-analysis of randomized clinical trials. J Am Dent Assoc. 2020 Dec;151(12):912-923.e10. doi: 10.1016/j.adaj.2020.08.016.
PubMed 33228884Madan N, Shashidhara Kamath K, Gopinath AL, Yashvanth A, Vaibhav N, Praveen G. A Randomized Controlled Study Comparing Efficacy of Classical and Gow-Gates Technique for Providing Anesthesia During Surgical Removal of Impacted Mandibular Third Molar: A Split Mouth Design. J Maxillofac Oral Surg. 2017 Jun;16(2):186-191. doi: 10.1007/s12663-016-0960-0. Epub 2016 Sep 15.
PubMed 28439159Montserrat-Bosch M, Figueiredo R, Nogueira-Magalhaes P, Arnabat-Dominguez J, Valmaseda-Castellon E, Gay-Escoda C. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial. Med Oral Patol Oral Cir Bucal. 2014 Jul 1;19(4):e391-7. doi: 10.4317/medoral.19554.
PubMed 24608204Figueiredo R, Sofos S, Soriano-Pons E, Camps-Font O, Sanmarti-Garcia G, Gay-Escoda C, Valmaseda-Castellon E. Is it possible to extract lower third molars with infiltration anaesthesia techniques using articaine? A double-blind randomized clinical trial. Acta Odontol Scand. 2021 Jan;79(1):1-8. doi: 10.1080/00016357.2020.1760348. Epub 2020 May 13.
PubMed 32401086Kim 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 30402548Madan GA, Madan SG, Madan AD. Failure of inferior alveolar nerve block: exploring the alternatives. J Am Dent Assoc. 2002 Jul;133(7):843-6. doi: 10.14219/jada.archive.2002.0298.
PubMed 12148677Yang F, Gao Y, Zhang L, Zheng B, Wang L, Sun H, Huang D. Local anaesthesia for surgical extraction of mandibular third molars: a systematic review and network meta-analysis. Clin Oral Investig. 2020 Nov;24(11):3781-3800. doi: 10.1007/s00784-020-03490-3. Epub 2020 Aug 24.
PubMed 32833132Sawang K, Chaiyasamut T, Kiattavornchareon S, Pairuchvej V, Bhattarai BP, Wongsirichat N. Double versus single cartridge of 4% articaine infiltration into the retro-molar area for lower third molar surgery. J Dent Anesth Pain Med. 2017 Jun;17(2):121-127. doi: 10.17245/jdapm.2017.17.2.121. Epub 2017 Jun 29.
PubMed 28879339Renton T, Janjua H, Gallagher JE, Dalgleish M, Yilmaz Z. UK dentists' experience of iatrogenic trigeminal nerve injuries in relation to routine dental procedures: why, when and how often? Br Dent J. 2013 Jun;214(12):633-42. doi: 10.1038/sj.bdj.2013.583.
PubMed 23787854Hillerup S, Jensen R. Nerve injury caused by mandibular block analgesia. Int J Oral Maxillofac Surg. 2006 May;35(5):437-43. doi: 10.1016/j.ijom.2005.10.004. Epub 2005 Dec 15.
PubMed 16343853
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Administration of Different Doses of 4% Articaine (1:100,000 Epinephrine) Using the Lower Dental Nerve Block Technique for Lower Third Molar Extraction. A Triple-blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06644950
- Acronym / sponsor ID
- 28/2022
- Conditions
- Tooth Extraction Status Nos, Anesthesia, Local
- Keywords
- anesthesia, block nerve, wisdom tooth, wisdom tooth extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 16 Oct 2024 (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.
The goal of this triple-blind randomized clinical trial is to compare the efficacy and safety of administering one cartridge (1.8 mL) versus two cartridges of articaine 4% with epinephrine 1:100,000 for lower third molar extraction using the inferior alveolar nerve block technique.
The main questions it aims to answer are:
- The injection of 3.6 ml of 4% articaine 1:100,000 has a higher anesthetic efficacy than a single injection of 1.8 ml of the same anesthetic.
- The injection of 3.6 ml of 4% articaine 1:100,000 has a higher rate of adverse effects than a single injection of 1.8 ml of the same anesthetic.
- The injection of 3.6 ml of 4% articaine 1:100,000 has a greater alteration of heart rate, oxygen saturation and systolic and diastolic blood pressure than a single injection of 1.8 ml of the same anesthetic.
The investigator (XA) will perform the anesthetic technique.
- The investigator will administer a first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened.
- In the control group, a single cartridge of anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds.
- In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.
- After checking Vincent's sign, the vestibular (buccal nerve) infiltration will be performed in both groups with half a cartridge (0.9 ml) of the same anesthetic solution.
- The latency of the anesthetic effect will be measured using a pulpometer.
- Subsequently, a student of the Master's Degree in Oral Surgery of the University of Barcelona will perform the surgical intervention. The surgeons in charge of performing the extraction will not know to which group each patient belongs.
- The collection of the variables and the postoperative controls will be carried out by the researcher who has not performed the anesthetic technique and who will not know the study group to which the patient belongs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Two cartridges of anesthetic | Experimental | Other: Efficacy and safety of administering 1 or two cartridges of anesthesiaTwo anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block. |
| Single cartridge of anesthetic | Active comparator | Other: Efficacy and safety of administering 1 or two cartridges of anesthesiaIn the control group, a single cartridge of anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without needle, in the same area, counting up to 30 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of legal age (≥18 years) requiring surgical extraction of a lower wisdom tooth (whether erupted, semi-erupted or included).
- Patients without relevant systemic pathology (equal or lower than ASA II).
- Sufficient intellectual capacity to understand the study, the informed consent and to adequately complete the questionnaires.
Key exclusion criteria (5 listed)
- Pregnant patients.
- Patients with hypersensitivity to articaine or adrenaline.
- Patients with uncontrolled systemic diseases.
- Drugs or systemic diseases (ASA III or higher) and that contraindicate a surgical intervention or the use of anesthetics and/or vasoconstrictors.
- Patients with relative or absolute contraindication of conventional analgesic or anti-inflammatory regimen.
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 |
|---|---|---|
| Efficacy and safety of administering 1 or two cartridges of anesthesiaThe investigator will administer the first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened. In the control group, only the first anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds. In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block. | Other | Single cartridge of anesthetic, Two cartridges of anesthetic |
Primary outcome
To compare the efficacy of administering one or two cartridges of articaine 4% with epinephrine 1:100,000 using the direct approach of the lower dental nerve block
Time frame: 1 hour
Determined by: * Achieving Vincent's sign within 6 minutes after injection. * Reporting a negative response to the pulpometer within 6 minutes after injection. * Absence of need for reanesthesia during the surgical procedure.
2 secondary outcomes
To compare the safety of both techniques
Time frame: 7 days
Determine the hemodynamic changes that occur during surgery.
Time frame: 1 to 2 hours
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 16 Oct 2024.
- Results publication: PubMed 29797177Duarte-Rodrigues L, Miranda EFP, Souza TO, de Paiva HN, Falci SGM, Galvao EL. Third molar removal and its impact on quality of life: systematic review and meta-analysis. Qual Life Res. 2018 Oct;27(10):2477-2489. doi: 10.1007/s11136-018-1889-1. Epub 2018 May 24.
- Results publication: PubMed 34204470Ku JK, Kim JY, Jun MK, Jeong YK, Huh JK. Influence of General and Local Anesthesia on Postoperative Pain after Impacted Third Molar Surgery. J Clin Med. 2021 Jun 17;10(12):2674. doi: 10.3390/jcm10122674.
- Results publication: PubMed 30878593Sainz de Baranda B, Silvestre FJ, Silvestre-Rangil J. Relationship Between Surgical Difficulty of Third Molar Extraction Under Local Anesthesia and the Postoperative Evolution of Clinical and Blood Parameters. J Oral Maxillofac Surg. 2019 Jul;77(7):1337-1345. doi: 10.1016/j.joms.2019.02.020. Epub 2019 Feb 20.
- Results publication: PubMed 29450738Olmedo-Gaya MV, Manzano-Moreno FJ, Munoz-Lopez JL, Vallecillo-Capilla MF, Reyes-Botella C. Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction. Clin Oral Investig. 2018 Dec;22(9):2981-2988. doi: 10.1007/s00784-018-2386-1. Epub 2018 Feb 15.
- Results publication: PubMed 32473767Camps-Font O, Figueiredo R, Sanchez-Torres A, Cle-Ovejero A, Coulthard P, Gay-Escoda C, Valmaseda-Castellon E. Which is the most suitable local anaesthetic when inferior nerve blocks are used for impacted mandibular third molar extraction? A network meta-analysis. Int J Oral Maxillofac Surg. 2020 Nov;49(11):1497-1507. doi: 10.1016/j.ijom.2020.04.016. Epub 2020 May 27.
- Results publication: PubMed 33228884Santos-Sanz L, Toledano-Serrabona J, Gay-Escoda C. Safety and efficacy of 4% articaine in mandibular third-molar extraction: A systematic review and meta-analysis of randomized clinical trials. J Am Dent Assoc. 2020 Dec;151(12):912-923.e10. doi: 10.1016/j.adaj.2020.08.016.
- Results publication: PubMed 28439159Madan N, Shashidhara Kamath K, Gopinath AL, Yashvanth A, Vaibhav N, Praveen G. A Randomized Controlled Study Comparing Efficacy of Classical and Gow-Gates Technique for Providing Anesthesia During Surgical Removal of Impacted Mandibular Third Molar: A Split Mouth Design. J Maxillofac Oral Surg. 2017 Jun;16(2):186-191. doi: 10.1007/s12663-016-0960-0. Epub 2016 Sep 15.
- Results publication: PubMed 24608204Montserrat-Bosch M, Figueiredo R, Nogueira-Magalhaes P, Arnabat-Dominguez J, Valmaseda-Castellon E, Gay-Escoda C. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial. Med Oral Patol Oral Cir Bucal. 2014 Jul 1;19(4):e391-7. doi: 10.4317/medoral.19554.
- Results publication: PubMed 32401086Figueiredo R, Sofos S, Soriano-Pons E, Camps-Font O, Sanmarti-Garcia G, Gay-Escoda C, Valmaseda-Castellon E. Is it possible to extract lower third molars with infiltration anaesthesia techniques using articaine? A double-blind randomized clinical trial. Acta Odontol Scand. 2021 Jan;79(1):1-8. doi: 10.1080/00016357.2020.1760348. Epub 2020 May 13.
- Results publication: 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.
- Results publication: PubMed 12148677Madan GA, Madan SG, Madan AD. Failure of inferior alveolar nerve block: exploring the alternatives. J Am Dent Assoc. 2002 Jul;133(7):843-6. doi: 10.14219/jada.archive.2002.0298.
- Results publication: PubMed 32833132Yang F, Gao Y, Zhang L, Zheng B, Wang L, Sun H, Huang D. Local anaesthesia for surgical extraction of mandibular third molars: a systematic review and network meta-analysis. Clin Oral Investig. 2020 Nov;24(11):3781-3800. doi: 10.1007/s00784-020-03490-3. Epub 2020 Aug 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy and safety of administering 1 or two cartridges of anesthesia in people with Tooth Extraction Status Nos and Anesthesia, Local, run by University of Barcelona at 1 site in Spain.
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 16 Oct 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 Spain. 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?
To compare the efficacy of administering one or two cartridges of articaine 4% with epinephrine 1:100,000 using the direct approach of the lower dental nerve block (time frame: 1 hour). 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 NCT06644950, 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 16 Oct 2024.