Comparison of Anesthetic Efficacy and Safety Between Inferior Alveolar Nerve Block and the Infiltrative Technique for the Treatment of Peri-implant Diseases in Posterior Mandibular Implants

NCT07590037 | Not Yet Recruiting DMC

• 1 other identifier: Anestesia periimplantitis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This triple-blind randomized clinical trial aims to compare the anesthetic efficacy and safety of two local anesthesia techniques for the surgical treatment of peri-implantitis in posterior mandibular implants: inferior alveolar nerve block (IANB) and infiltrative anesthesia with 4% articaine and epinephrine 1:100,000. Peri-implantitis is an inflammatory disease affecting the tissues around dental implants, characterized by progressive bone loss and clinical signs of inflammation. When non-surgical therapy is insufficient, surgical treatment is required, usually involving flap elevation, debridement of granulation tissue, implant surface decontamination, and, depending on the defect, resective, regenerative, or combined surgery. Effective local anesthesia is essential in these procedures, especially in the posterior mandible, where dense bone may limit anesthetic diffusion. IANB is the conventional technique for achieving profound mandibular anesthesia, but it may fail due to anatomical variations, accessory innervation, or technical difficulty. Infiltrative anesthesia has been proposed as an alternative, particularly with articaine because of its high diffusion capacity, although its predictability in complex mandibular surgery remains uncertain. The main objective is to compare the efficacy of IANB and infiltrative anesthesia, measured by the need for re-anesthesia during surgery. Secondary objectives include assessing safety, intraoperative discomfort, postoperative pain, duration of anesthesia, patient satisfaction, and adverse events. Adult patients requiring surgical treatment for peri-implantitis in posterior mandibular implants at the Dental Hospital of the University of Barcelona will be included. Eligible participants must be ≥18 years old, medically fit for surgery, and able to understand the study and complete the questionnaires. Exclusion criteria include pregnancy, allergy to articaine or epinephrine, uncontrolled systemic disease, coagulation disorders or anticoagulant medication, ASA III or higher status, and contraindications to conventional analgesic or anti-inflammatory medication. Participants will be randomly assigned to either the IANB group or the infiltrative anesthesia group. Randomization will be performed using a computer-generated sequence placed in opaque, sequentially numbered envelopes. The patient, surgeon, outcome assessor, and statistician will remain blinded to group allocation. The study includes three visits. At the first visit, eligibility will be assessed and informed consent obtained. At the second visit, surgery will be performed after the assigned anesthetic technique. Patients will record pain using visual analogue scales at injection, during surgery, 2 h, 6 h, 12 h, 24 h, and daily until day 7, as well as rescue medication use and sick leave. At the third visit, 7-9 days after surgery, postoperative healing, complications, adverse events, pain diary, and patient satisfaction will be assessed. The primary outcome is anesthetic efficacy, defined as absence of need for re-anesthesia. Secondary variables include demographic factors, systemic disease, medication, smoking, dental anxiety, type and duration of surgery, surgeon experience, number and position of implants, intraoperative and postoperative pain, duration of anesthesia, adverse events, complications, and patient-reported experience measures. Data will be analyzed using Stata/IC 15.1. Quantitative variables will be described using means and standard deviations or medians and interquartile ranges, depending on normality. Qualitative variables will be presented as frequencies and percentages. Group comparisons will use appropriate statistical tests, with significance set at p \< 0.05. As a pilot exploratory trial, the study will include 30 patients, 15 per group. Its aim is to assess feasibility, estimate preliminary event rates, and generate data for future confirmatory trials. The study will follow the Declaration of Helsinki and applicable data protection regulations. Participation will be voluntary, anonymous, and based on written informed consent.

Conditions

Local Anesthesia; Dental Implants; Periimplantitis

Keywords

dental implants; articaine; periimplantitis; block nerve; local anesthesia

Outcome Measures

Primary Outcomes (1)

• Anesthetic efficacy

  This variable is defined as the absence of need for re-anesthesia during the surgical procedure and the Vincent's sign achievement within 6 minutes

  1 hour

Secondary Outcomes (2)

• To evaluate the adverse effects of the anesthetic techniques (IANB versus infiltrative technique) used in the surgical treatment of peri-implantitis in posterior mandibular implants.

  7 days

• To analyze postoperative pain associated with the surgical treatment of peri-implantitis in posterior mandibular implants in patients anesthetized with IANB compared with those anesthetized with infiltrative techniques.

  7 days

Study Arms (2)

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 implant to be treated.

Procedure: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for periimplantitis surgical treatment in poosterior mandibular implants

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 periimplantitis surgical treatment in poosterior mandibular implants

Interventions

Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for periimplantitis surgical treatment in poosterior mandibular implants PROCEDURE

The surgeon and his assistant will leave the operating room and the study investigator in charge of anesthetizing the patients 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:

• Adult patients (≥18 years) requiring surgical treatment of peri-implantitis in the posterior mandibular sector.
• Patients without relevant systemic disease (ASA II or lower).
• Sufficient intellectual capacity to understand the study and informed consent and to complete the questionnaires adequately.

You may not qualify if:

• Pregnant patients.
• Patients with allergy or hypersensitivity to articaine or epinephrine.
• Patients with uncontrolled systemic diseases.
• Patients with coagulation disorders or medication that alters coagulation.
• Patients who may be able to recognize the anesthetic technique used, such as 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 to conventional analgesic or anti-inflammatory regimens.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital odontológic de Bellvitge, Universitat de Barcelona,

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Xavier Arias-Huerta, DDS, Ms

CONTACT

+34687199158; xaviariash@gmail.com

Jorge Toledano-Serrabona, DDS, Ms, PhD

CONTACT

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: May 9, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

ES (1)