Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement.
NCT ID: NCT06641232
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
42 participants
INTERVENTIONAL
2024-11-05
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* The anesthetic efficacy of the IDNB technique, measured as the number of reanesthesias during the surgical procedure, is superior to the infiltrative technique in the placement of dental implants in the posterior mandibular area.
* The IDNB technique presents a higher rate of adverse effects than TINF in the placement of dental implants in the posterior mandibular area.
* The IDNB technique presents less postoperative pain than TINF in the placement of dental implants in the posterior mandibular area.
The investigator (XA) will perform the anesthetic technique. A modified dental anxiety questionnaire (MDAS) will be administered prior to surgery. Then, 2g of Amoxicillin will be administered 1 hour before the surgery. Subsequently, the surgeon and his assistant will prepare the surgical field with sterile sizes. The surgeon and assistant will then leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.
The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo IDNB together with buccal nerve block.
The anesthetic latency time will be determined by using a pulpometer on the most posterior tooth in the arch.
Failure to achieve sufficient anesthetic depth, as measured by pulpometer, within 6 minutes of the last puncture will be considered early anesthetic failure and will be counted as such.
* 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 surgery 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inferior dental nerve block
One articaine cartridge (1.8 mL of articaine 4% at 1:100,000) with the direct technique for the inferior dental nerve block and half a cartridge (0.9 mL) for the buccal nerve block.
Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.
The surgeon and his assistant will leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.
The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo inferior dental nerve block together with buccal nerve block.
Infiltrative
One anesthetic cartridge (1.8 mL of articaine 4% 1:100,000) using the vestibular infiltrative technique (supraperiosteal paraapical). Subsequently administer half a cartridge of anesthetic (0.9 mL of articaine 4% 1:100,000) using the infiltrative technique (supraperiosteal paraapical) lingually in the sublingual area of the tooth to be treated.
Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.
The surgeon and his assistant will leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.
The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo inferior dental nerve block together with buccal nerve block.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.
The surgeon and his assistant will leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.
The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo inferior dental nerve block together with buccal nerve block.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Patients with allergy or hypersensitivity to articaine or adrenaline.
* Patients with uncontrolled systemic diseases.
* Patients who may recognize the anesthetic technique used (e.g. dentists).
* Drugs or systemic diseases (ASA III or higher) that contraindicate surgical intervention or the use of anesthetics and/or vasoconstrictors.
* Patients with relative or absolute contraindication of conventional analgesic or anti-inflammatory regimen.
* Immediate implants.
* Surgeries requiring bone grafts.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Barcelona
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adrià Jorba García
Prof. dr (DDS, MS,PhD)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital odontológic de Bellvitge, Universitat de Barcelona
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Jorge Toledano-Serrabona, DDS, Ms, PhD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Eduard Valmaseda Castellón
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Garcia-Blanco M, Gualtieri AF, Puia SA. A randomized controlled trial comparing nerve block and mandibular infiltration techniques in posterior mandible implant surgeries. J Clin Exp Dent. 2018 Oct 1;10(10):e1003-e1010. doi: 10.4317/jced.54330. eCollection 2018 Oct.
Heller AA, Shankland WE 2nd. Alternative to the inferior alveolar nerve block anesthesia when placing mandibular dental implants posterior to the mental foramen. J Oral Implantol. 2001;27(3):127-33. doi: 10.1563/1548-1336(2001)0272.3.CO;2.
Esteve-Pardo G, De-Larriva E, Salgado A, Bernabeu-Esclapez A, Bardaji JA, Esteve-Colomina L. Is Inferior Alveolar Nerve Block Needed to Perform Implant Surgery in the Posterior Mandible? A Randomized Controlled Trial. J Oral Maxillofac Surg. 2022 Mar;80(3):490-500. doi: 10.1016/j.joms.2021.09.028. Epub 2021 Oct 10.
Escoda CG, Aytés LB. Tratado De Cirugia Bucal. Anim Genet. 2008;39:561-3.
Sanchez-Siles M, Torres-Diez LC, Camacho-Alonso F, Salazar-Sanchez N, Ballester Ferrandis JF. High volume local anesthesia as a postoperative factor of pain and swelling in dental implants. Clin Implant Dent Relat Res. 2014 Jun;16(3):429-34. doi: 10.1111/cid.12005. Epub 2012 Sep 21.
Sancho-Puchades M, Vilchez-Perez MA, Valmaseda-Castellon E, Paredes-Garcia J, Berini-Aytes L, Gay-Escoda C. Bupivacaine 0.5% versus articaine 4% for the removal of lower third molars. A crossover randomized controlled trial. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e462-8. doi: 10.4317/medoral.17628.
Gaffen AS, Haas DA. Retrospective review of voluntary reports of nonsurgical paresthesia in dentistry. J Can Dent Assoc. 2009 Oct;75(8):579.
Garisto GA, Gaffen AS, Lawrence HP, Tenenbaum HC, Haas DA. Occurrence of paresthesia after dental local anesthetic administration in the United States. J Am Dent Assoc. 2010 Jul;141(7):836-44. doi: 10.14219/jada.archive.2010.0281.
Haas DA, Lennon D. A 21 year retrospective study of reports of paresthesia following local anesthetic administration. J Can Dent Assoc. 1995 Apr;61(4):319-20, 323-6, 329-30.
Hillerup 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.
Renton 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.
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.
Camps-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.
Santos-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.
Bataineh AB, Alwarafi MA. Patient's pain perception during mandibular molar extraction with articaine: a comparison study between infiltration and inferior alveolar nerve block. Clin Oral Investig. 2016 Nov;20(8):2241-2250. doi: 10.1007/s00784-016-1712-8. Epub 2016 Jan 21.
Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.
Fischer K, Stenberg T. Prospective 10-year cohort study based on a randomized controlled trial (RCT) on implant-supported full-arch maxillary prostheses. Part 1: sandblasted and acid-etched implants and mucosal tissue. Clin Implant Dent Relat Res. 2012 Dec;14(6):808-15. doi: 10.1111/j.1708-8208.2011.00389.x. Epub 2011 Oct 18.
Degidi M, Nardi D, Piattelli A. 10-year follow-up of immediately loaded implants with TiUnite porous anodized surface. Clin Implant Dent Relat Res. 2012 Dec;14(6):828-38. doi: 10.1111/j.1708-8208.2012.00446.x. Epub 2012 Feb 29.
Buser D, Janner SF, Wittneben JG, Bragger U, Ramseier CA, Salvi GE. 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: a retrospective study in 303 partially edentulous patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):839-51. doi: 10.1111/j.1708-8208.2012.00456.x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-2024
Identifier Type: -
Identifier Source: org_study_id