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

May 4, 2026 updated by: Adrià Jorba García, University of Barcelona

Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement. A Triple-blind Randomized Clinical Trial.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital odontológic de Bellvitge, Universitat de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • - 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of anesthetic techniques used in the placement of dental implants in the posterior mandibular region.
Time Frame: 7 days
Determined by the appearance or absence of adverse effects, such as : Disorientation, dizziness, blurred vision, nausea, vomiting, tremors, convulsions, vasovagal syncope, paresthesia or trismus.
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.
Time Frame: 7 days
Determined using a visual anlogical scale of 10 cm at the 2, 6, and 12 hours posteriors to the surgery and then everyday until the 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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