Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement.

NCT06641232 | Active Not Recruiting DMC

• 1 other identifier: 23-2024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this triple blind randomized clinical trial is to compare the safety, efficacy and postoperative pain between the inferior dental nerve block (IDNB) and the infiltrative technique (TINF) in the placement of mandibular posterior dental implants in patients with partial edentulism. 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.

Conditions

Dental Implants; Local Anesthesia

Keywords

dental implants; local anesthesia; block nerve

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of the inferior dental nerve block and the infiltrative technique in the placement of mandibular posterior dental implants in patients with partial edentulism.

  Determined by: Reporting a negative response to the pulpometer within 6 minutes after injection. Absence of need for reanesthesia during the surgical procedure.

  1 hour

Secondary Outcomes (2)

• To evaluate the safety of anesthetic techniques used in the placement of dental implants in the posterior mandibular region.

  7 days

• To analyze the postoperative pain associated with the placement of mandibular implants using an inferior dental nerve block compared to those implanted with infiltrative techniques.

  7 days

Study Arms (2)

Inferior dental nerve block

EXPERIMENTAL

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.

Procedure: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.

Infiltrative

ACTIVE COMPARATOR

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.

Procedure: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.

Interventions

Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement. PROCEDURE

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.

Inferior dental nerve block; Infiltrative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of legal age (≥18 years), partially edentulous, requiring the placement of one or more mandibular implants in the molar area.
• 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.

You may not qualify if:

• \- Pregnant patients.
• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital odontológic de Bellvitge, Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (19)

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  PMID: 12500871 BACKGROUND

• Escoda CG, Aytés LB. Tratado De Cirugia Bucal. Anim Genet. 2008;39:561-3.

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  PMID: 22143739 BACKGROUND

• 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.

  PMID: 32473767 BACKGROUND

• 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.

  PMID: 30386507 RESULT

• 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.

  PMID: 34762850 RESULT

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  PMID: 22998596 RESULT

• Gaffen AS, Haas DA. Retrospective review of voluntary reports of nonsurgical paresthesia in dentistry. J Can Dent Assoc. 2009 Oct;75(8):579.

  PMID: 19840499 RESULT

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  PMID: 20592403 RESULT

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  PMID: 7736335 RESULT

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  PMID: 16343853 RESULT

• 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.

  PMID: 23787854 RESULT

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  PMID: 30402548 RESULT

• 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.

  PMID: 33228884 RESULT

• 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.

  PMID: 26791025 RESULT

• 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.

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• 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.

  PMID: 22008715 RESULT

• 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.

  PMID: 22376174 RESULT

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  PMID: 22897683 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr (DDS, MS,PhD)

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

ES (1)