Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement. A Triple-blind Randomized Clinical Trial.
| Registry | NCT06641232 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 42 (Estimated) |
| Sponsor | University of Barcelona (Other) |
| Conditions | Dental Implants, Local Anesthesia |
| Interventions | Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement. (Procedure) |
| Dates | start 2024-11-05, primary completion 2026-06-10, completion 2026-12-01 (estimated), first posted 2024-10-15, last updated 2026-10-06 |
| Locations | 1 site in Spain |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Inferior dental nerve block | Experimental | Procedure: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement. | 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. |
| Infiltrative | Active comparator | Procedure: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement. | 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital odontológic de Bellvitge, Universitat de Barcelona | L'Hospitalet de Llobregat, Barcelona | Spain |