Clinical Research Directory

LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women

The primary objective of this study is to evaluate the impact of LF111 and drospirenone (DRSP) 3.5 mg chewable tablets on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods. Secondary objectives include further evaluating the impact of LF111 and DRSP 3.5 mg chewable tablets on BMD and bone turnover after 12 months (13 medication cycles) in comparison to non-hormonal contraceptive methods and assessing the general safety and tolerability of LF111 and DRSP 3.5 mg chewable tablets in comparison to non-hormonal contraceptive methods. Exploratory objectives include evaluating the impact of LF111 and DRSP 3.5 mg chewable tablets on body fat and lean mass after 12 months (13 medication cycles) of investigation.

Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss

The study aims to utilize medical devices, such as the Xtreme CT and XCT 3000, to assess bone and muscle microarchitecture for various pathologies. The devices provide crucial data on bone and muscle density, aiding in understanding fracture risks associated with conditions like rheumatoid arthritis and neurological disorders. Current methods like DXA scanning have limitations in predicting fracture risks accurately due to their inability to assess cortical and trabecular microstructure. The study emphasizes the importance of evaluating cortical porosity and trabecular volume loss, especially in conditions like post-menopausal osteoporosis and sarcopenia. Additionally, it explores the impact of neurological disorders, renal insufficiency, and endocrinopathies on bone health. Furthermore, the study aims to establish a control group to differentiate pathological changes from age-related variations. Expected outcomes include a comprehensive understanding of bone microarchitecture alterations across various pathologies and the potential to improve fracture risk estimation beyond conventional methods like DEXA scanning. Ultimately, the study anticipates facilitating better management strategies to reduce fracture risks associated with these conditions.

Success and Survival Rate of Tranmucosal Versus Bone Level Implants: Randomized Clinical Trial

The purpose of this study is to assess changes in peri-implant tissues and the effectiveness of a tissue-level surgical technique. This technique will be compared with a bone-level surgical technique. This is a post-marketing clinical investigation conducted in the Endodontics Department of the Dental Clinic at the University of Bologna. Patient recruitment and study conduction will follow the principles of the Declaration of Helsinki and adhere to major international guidelines (CONSORT). Implants will be placed using either a bone-level or tissue-level surgical technique, corresponding to implants positioned at the level of the gingival mucosa or submerged implants, respectively. Randomization (1:1 ratio) will be conducted before surgery to create two treatment groups. The experimental group (Tissue Level) (n=40) consists of implants that will be placed with the exposed neck (Tissue-level surgical technique). The control group (n=40) comprises implants placed at the bone level (Bone-level surgical technique). The surgeon will be aware of patient assignment during the implant insertion procedures. The surgical procedure to uncover the implant neck (control group) will be performed 3 months after implant placement. The experimental group (Tissue Level technique) will not require a surgical intervention. he following parameters will be assessed at 1, 6, 12, and 36 months after implant placement: Peri-implant parameters: Plaque score, Bleeding on Probing (BoP), and Papilla Index Radiographic parameters: Marginal Bone Level (MBL) Patient-Reported Outcome Measure (PROM): Post-operative pain (VAS) in the experimental group (non-submerged surgical technique) and the control group (submerged surgical technique).

Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)

In this prospective multicenter study, a population of adult individuals consecutively treated for revision hips, requiring a custom-made acetabular implant for non-oncological reasons, will be included. The custom-made implant is a personalized implant produced using additive manufacturing, based on the pre-operative CT scan that details the bone damage. Patients eligible for this implant are those with severe acetabular bone damage Paprosky 3 (loss of the superolateral part and one of the two ventro-caudal walls). Preoperatively, the patient will undergo a clinical evaluation. Data will be collected on the patient's general health status with the Charlson score, the reason for revision, number of revisions, type of implant in place, and the time elapsed between the failed implant and the revision in question. The bone deficit will be studied through CT measurements according to qualitative and quantitative scales. During the surgery, information on intraoperative complications will be collected. In the postoperative period, perioperative complications will be collected according to the Clavien Dindo classification. The clinical radiographic evaluations will be carried out during outpatient follow-up visits at 1, 3, 12, 24, and 36 months after revision. They include the Harris Hip Score clinical score, the EQ-5D PROM, and the patient's satisfaction level (qualitative assessment in 4 grades: unsatisfied, slightly satisfied, moderately satisfied, fully satisfied). The positional parameters of the implant will be evaluated, as compared to the immediate post-operative X-ray: acetabular abduction, acetabular anteversion, center of rotation height, center of rotation medialization, and inclination of the custom-made component. From 12 months onwards, the osteointegration characteristics of the component will be assessed: presence of radial trabeculae at the interface, superolateral and inferior reinforcements, stress shielding, absence of radiolucent lines. Re-revision rates will be determined using the Kaplan-Meier method. The reasons for re-revision will be noted.

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).

Minimally Invasive Sinus Lift Through the Interradicular Septum

This study aims to describe a new approach for the reconstruction of the alveolar process in the sinus area. This minimally invasive approach will access the maxillary sinus through the alveolar process, elevating the sinus membrane in the area immediately above it. The regeneration may be achieved in the specific area required for dental implant placement, reducing the morbidity of the procedure.

All-on-X Stackable Guides for Maxillary Terminal Dentition

This retrospective study will evaluate the clinical performance of maxillary All-on-X(full-arch implant-supported rehabilitation) implant rehabilitation using stackable guided surgery and immediate loading. Implant survival and peri-implant outcomes will be assessed over a 2-year follow-up, with regression analysis will be used to investigate the influence of surgical and prosthetic variables, including basal seating guide design.

Ridge Augmentation Using Allograft Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor

This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).

Bone, Exercise, Alendronate, and Caloric Restriction

The purpose of this research is to identify strategies that minimize bone loss that occurs when older adults lose weight. Participation in this research will involve up to nine assessment visits and last up to two years.

Release Kinetics of rhBMP-2 Using E-PRF as an Autologous Carrier: An In Vitro Analysis

This study is seeking to evaluate the binding of a commercially-available, recombinant human osteoinductive growth factor, rhBMP-2, to a human blood derived product scaffold, enhanced Platelet-rich fibrin (E-PRF), and the release of such a growth factor over time in an in vitro (laboratory) environment. The investigators will compare these release kinetics to those of the FDA approved carrier for rhBMP-2, an absorbable collagen sponge (ACS), a combination of E-PRF and ACS, and E-PRF alone.

Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis

This study is seeking to evaluate that platelet-derived growth factor-BB (PDGF-BB) is a proven wound healing and osteogenic protein that plays a critical role in wound healing and previous research has demonstrated a non-linear response where higher dosages produced less effect. As Platelet Rich Fibrin (PRF) contains numerous platelets, it contains PDGF-BB, but at levels lower than in the commercially available product and with inter-individual variation, GEM21S. To achieve both ideal handling and achieve ideal levels of PDGF-BB, there is a rationale to add GEM 21S recombinant human platelet-derived growth factor-BB (rhPDGF) to a bone graft prior to making "sticky bone".

The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.

To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.

CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis

Study is looking at the effects of cystic fibrosis treatment on bone muscle.

Lutein, Zeaxathin, and Fish Oil Supplementation

The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults. The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months? Subjects with an MPOD \<.43 will significantly improve MPOD after 6-months of LZF supplementation. Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density. Participants will be asked to take either a LZF supplement or placebo daily for 6 months.

Prospective Outcomes of Guided Equator Overdentures

This prospective clinical study evaluated the 3-year performance of mandibular implant-supported overdentures (IODs) placed using a fully guided static computer-assisted implant surgery (CAIS) protocol. Primary outcomes included implant survival, peri-implant soft tissue health, and marginal bone loss. Findings provide evidence for the predictability of digital surgical workflows in removable prosthodontics.

Crestal Bone Response to Narrow vs. Regular Tie-Base in Subcrestal Implants

This 24-month randomized clinical trial evaluates peri-implant marginal bone changes at subcrestal implants restored with narrow versus regular tie-base abutments. The study investigates whether narrow or regular tie-base abutments influence peri-implant crestal bone remodeling over 24 months. This trial assesses the effect of abutment diameter (narrow vs. regular tie-base) on marginal bone stability at subcrestal implants after 24 months. We aimed to determine if abutment diameter impacts peri-implant marginal bone levels by comparing narrow and regular tie-base abutments in a 24-month RCT.

Prosthetic Modality and MBL

The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year. Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Once the implant is inserted, patients will be divided into three groups according to the time if their inclusion in the study. Study groups (20 patients per group): 1. Group 1: Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. 2. Group 2: Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. 3. Group 3: Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months. Consecutive inclusion of patients - 1st- group 1, 2nd - group 2, 3rd - group 3 and vice versa. Primary outcome variable: bone level changes 12 months post-loading

An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group. Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations. In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.

Mandibular Overdentures Retained by Four Locator Attachments Versus Four-Implant Bar Attachments

This 10-year retrospective study investigates residual ridge changes in edentulous patients treated with mandibular overdentures (ODs) retained by either four Locator attachments or a four-implant bar system. Although two-implant ODs are well established, four-implant configurations may offer enhanced stability and function. Locator and bar attachments are commonly used, but their long-term effects on bone resorption patterns-especially posterior mandibular and anterior maxillary resorption-remain unclear. By standardizing implant positions, this study aims to directly compare the two systems to help guide clinicians in selecting the most effective attachment type for long-term success.

Induced Membrane Properties in Children and Adults

Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.

Study on Safety and Performance of AdvanCore Bone Void Filler

The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

Osteogenic Action of a Medical Device Based on Beta-tricalcium Phosphate (BTCP)

The general objective of this split-mouth study is to analyze the osteogenic action of BTCP during the bone regeneration process following the extraction of impacted mandibular third molars.

Biomechanical Effects of Digitally Constructed Subperiosteal Implants

Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.

Cohort Study on Plant-based Diets (COPLANT Study)

The Cohort on Plant-based Diets (COPLANT) study is a multi-centre cohort study that starts baseline recruitment from 2024 to 2027 with approximately 6,000 participants in Germany and Austria. The COPLANT study focuses on vegan (no animal products), vegetarian (no meat and fish, but dairy products and eggs), pescetarian (no meat, but fish) and omnivorous (mixed diet including all possible animal products) diets. The aim of the COPLANT study is to gain new insights on health benefits and risks as well as social, ecological and economic effects of different plant-based diets in comparison to a mixed diet. In addition to a detailed dietary survey using an app adapted to the needs of this study, the baseline examination includes measurements of body composition, bone health, cardiovascular risk factors, diabetes risk, contaminants and lifestyle. For the basic laboratory program, fasting blood, 24-hour urine collection and a stool sample are taken from all study participants. Furthermore, specific aspects of dietary behavior, physical activity and other lifestyle factors are collected via questionnaires. Follow-up studies are planned at intervals of 5, 10 and 20 years after the baseline visit.