Clinical Research Directory

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

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.

MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal Surgery

This clinical study investigates how the subgingival microbiome changes after three different periodontal and peri-implant surgical procedures: (1) resective periodontal surgery, (2) regenerative periodontal surgery, and (3) peri-implantitis surgery. The aim is to characterize microbial shifts associated with these commonly used surgical treatments and to determine whether the type of surgery influences the recovery or disruption of the subgingival ecosystem. Adult patients with periodontitis or peri-implantitis will receive the procedure indicated for their condition. Subgingival plaque samples will be collected at baseline and at defined postoperative follow-up intervals. Microbiome analysis will be performed using next-generation sequencing (NGS), and microbial changes will be evaluated with the Subgingival Microbial Dysbiosis Index (SMDI). Insights from this study may help improve prevention, diagnostics, and treatment strategies for periodontal and peri-implant diseases.

Occlusal Load Distribution and Periodontal Status

Occlusal forces are unevenly distributed among teeth during mastication, potentially predisposing certain teeth to higher functional loads. Teeth subjected to increased occlusal loading may be at greater risk of periodontal breakdown, especially in patients with pre-existing periodontal disease. Technological advances, such as mandibular movement recording systems, allow for precise assessment of occlusal contacts and load distribution. However, the relationship between occlusal loading patterns and periodontal status remains insufficiently investigated. This study aims to evaluate whether teeth exposed to higher masticatory loads show an association with periodontal disease severity.

Evaluation of the Effects of the Low-level Laser Therapy as an Adjunct to Nonsurgical Treatment in Patients With Periimplantitis

The main objective of this study is to evaluate the clinical efficacy of low-level laser therapy (LLLT) in addition to non-surgical periodontal treatment in patients with peri-implantitis. The study aims to investigate the anti-inflammatory and regenerative effects of low-level laser therapy on peri-implant soft and hard tissues and to reveal its contribution to treatment success. In this context, the specific objectives of the study are as follows: 1. To evaluate the effects of LLLT added to non-surgical mechanical treatment on clinical parameters such as plaque index, probing depth, bleeding index, and clinical attachment level. 2. To examine the contributions of laser therapy to tissue healing by analyzing biochemical markers in peri-implant sulcular fluid over time.

The Effect of Smoking on Peri-implantitis

the primary aim of this project is to evaluate the microbiological and inflammatory effect of smoking status and smoking severity on periimplantitis lesions. The secondary aim is to compare the effect of smoking on periimplantitis and periodontal microbiota and inflammation in the same individuals. There will include 96 patients, equally divided into four groups: Smokers with peri-implantitis (n=24), non-smoker individuals with peri-implantitis (n=24), smokers with healthy peri-implant tissues (n=24), non-smoker individuals with healthy peri-implant tissues (n=24). Microbiological and biochemical analyses will be performed on the samples taken.

Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants

The success of rehabilitation with osseointegrated implants is associated with numerous factors, including patient characteristics, installed implants, proper planning, and the prosthetic connections used. In the long term, success is closely related to the clinical radiographic follow-up of the implanted region and the identification of intrinsic or extrinsic factors that may interfere with implant survival. Therefore, the objective of this study is to evaluate, through clinical and radiographic analysis, the peri-implant tissues and prosthetic connections of research participants rehabilitated with osseointegrated implants at the Implant Dentistry Clinic of the Federal Fluminense University, over a period of 5 years. This will be a double-blind longitudinal study. A total of 148 research participants will be selected, respecting the inclusion criteria: completion of surgical-prosthetic planning by the Implant Dentistry Clinic team at UFF, including osseointegrated implants and prosthetic components manufactured by SIN Implant System (São Paulo, Brazil); agreeing to and signing the informed consent form, being willing to be monitored for a period of 5 years; systemically healthy patients who do not use antiresorptive and antiangiogenic drugs; patients with a plaque index \<20% (Ainamo \& Bay 1975) and bleeding on probing \<20% (Muhlemann \& Son 1971) at the start of the study. Participants will undergo clinical and radiographic analysis of peri-implant tissues and prosthetic connections at the following intervals: up to 7 days after implant installation (Time 0), at the time of prosthesis installation (Time 1), 6 months after prosthesis installation (Time 2), and 1 to 5 years after prosthesis installation (Times 3, 4, 5, 6, and 7, respectively). It is expected that this longitudinal study will lead to a better understanding of the factors influencing peri-implant bone loss and long-term success.