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
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- What is being studied
- The protocol lists: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for periimplantitis surgical treatment in poosterior mandibular implants.
- Who it may be relevant to
- Registry conditions: Local Anesthesia, Dental Implants, Periimplantitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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: A Triple-blind Randomized Clinical Trial
Overview
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.
Detailed description
This study is a triple-blind randomized clinical trial designed to compare the anesthetic efficacy and safety of two local anesthesia techniques used for the surgical treatment of peri-implantitis in posterior mandibular implants: the inferior alveolar nerve block (IANB) and the infiltrative technique (TINF), both performed with 4% articaine and epinephrine 1:100,000.
Background and rationale Peri-implantitis is an inflammatory disease affecting the tissues surrounding osseointegrated dental implants. It is characterized by progressive peri-implant bone loss together with clinical signs of inflammation. It represents one of the most relevant biological complications in implant dentistry.
Initial management of peri-implant diseases usually involves non-surgical therapy, including mechanical debridement of the implant surface, antiseptic irrigation, and, in selected cases, local or systemic antimicrobial therapy. However, when peri-implantitis progresses or does not respond adequately to non-surgical treatment, surgical intervention is often required. Surgical treatment may include flap elevation, removal of granulation tissue, implant surface decontamination, bone recontouring, regenerative procedures, soft tissue surgery, or combined approaches, depending on the morphology and severity of the defect.
Adequate local anesthesia is essential to perform these procedures safely and predictably. This is particularly relevant in the posterior mandible, where dense cortical bone may limit the diffusion of local anesthetic solutions. Traditionally, the inferior alveolar nerve block has been the standard technique for achieving profound anesthesia in mandibular posterior procedures. Although generally effective, its success may be affected by anatomical variation, accessory innervation, technical difficulty, or incomplete nerve blockade. In addition, although uncommon, transient neurosensory complications have been described.
The infiltrative technique has gained interest as a possible alternative, especially when using articaine, which has high tissue diffusion capacity due to its chemical structure. Articaine contains a thiophene ring, which increases lipid solubility and may facilitate penetration through dense tissues. It also has a rapid onset of action and favorable pharmacological characteristics for oral surgery. Despite this, the available evidence suggests that IANB may still provide greater anesthetic predictability in complex surgical procedures. There is a lack of well-designed randomized clinical trials directly comparing IANB and infiltrative anesthesia specifically in the surgical treatment of peri-implantitis in posterior mandibular implants.
For this reason, the study aims to provide controlled clinical data that may help guide evidence-based anesthetic decision-making in this specific surgical context.
Main objective The primary objective is to compare the anesthetic efficacy of the inferior alveolar nerve block and the infiltrative technique during the surgical treatment of peri-implantitis in posterior mandibular implants.
Anesthetic efficacy will be assessed through the need for re-anesthesia during the surgical procedure. The absence of re-anesthesia will be considered evidence of successful anesthesia.
Secondary objectives
The secondary objectives are to compare both anesthetic techniques in terms of:
Safety and incidence of adverse events.
Intraoperative discomfort.
Pain during anesthetic injection.
Postoperative pain intensity.
Duration of anesthesia.
Patient satisfaction with the anesthetic technique and surgical experience.
Need for rescue analgesic medication.
Postoperative complications.
Feasibility of the protocol for a future confirmatory clinical trial.
Hypotheses The main null hypothesis is that the anesthetic efficacy of IANB, measured by the number or frequency of re-anesthesia events during surgery, is not superior to that of infiltrative anesthesia in the surgical treatment of peri-implantitis in posterior mandibular implants.
The alternative hypothesis is that IANB provides superior anesthetic efficacy compared with infiltrative anesthesia in this clinical setting.
Secondary hypotheses include the possibility that IANB may be associated with a different safety profile, lower intraoperative discomfort, reduced postoperative pain, and higher patient satisfaction compared with the infiltrative technique.
Study design The study is designed as a randomized, triple-blind clinical trial. It is also described as a pilot and exploratory study because there is limited previous evidence in this exact clinical context, making it difficult to establish robust assumptions for a definitive sample size calculation.
The trial will be conducted at the Dental Hospital of the University of Barcelona, specifically within the Master's program in Oral Surgery and Bucofacial Implantology.
Study population The study will include consecutive adult patients attending the Implant Maintenance Unit or the Oral Surgery and Implantology service who require surgical treatment of peri-implantitis in posterior mandibular implants.
Patients will be assigned either to the experimental group, receiving IANB, or to the control group, receiving infiltrative anesthesia.
Inclusion criteria
Participants must meet the following criteria:
Age 18 years or older.
Need for surgical treatment of peri-implantitis in the posterior mandibular region.
Absence of relevant uncontrolled systemic disease, corresponding to ASA I or ASA II.
Sufficient intellectual capacity to understand the study, provide informed consent, and complete the questionnaires and pain records.
Exclusion criteria
Patients will be excluded if they meet any of the following conditions:
Pregnancy.
Allergy or hypersensitivity to articaine or epinephrine.
Uncontrolled systemic disease.
Coagulation disorders or medication affecting coagulation.
Ability to recognize the anesthetic technique used, for example dental professionals.
ASA III or higher systemic status.
Interventions
- Procedure Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for periimplantitis surgical treatment in poosterior mandibular implants
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.
Primary outcome measures
- Anesthetic efficacy [Time frame: 1 hour]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital odontológic de Bellvitge, Universitat de Barcelona, — L'Hospitalet de Llobregat
Identifiers
NCT: NCT07590037 · Anestesia periimplantitis