Clinical trials

This randomized controlled trial aims to evaluate the effectiveness of a smartphone-based chatbot in improving adherence to a 12-week home-based multicomponent exercise program in community-dwelling older adults. Participants will be randomly assigned to receive either a chatbot-supported exercise program delivered through Telegram or an equivalent paper-based exercise program. Both groups will perform the same exercise program, including strength, balance, flexibility, and walking exercises. The primary outcome is exercise adherence. Secondary outcomes include physical function, physical activity, participant satisfaction, usability of the chatbot, and adverse events. The study seeks to determine whether chatbot-based support can enhance adherence and improve health outcomes in older adults.

With this work we want to assess whether there are differences in the amount of physical activity per week, measured by accelerometry in 3 groups of subjects, where one group (G1) has been carrying out a PA program called "Enguera Sé Saludable" for a year. another group (G2) newly introduced to the same exercise program, and a control group (G3) that does not carry out an exercise program but declared itself active.

Indirect resin restorations had become a well-established conservative alternative to direct composite restorations in posterior teeth, particularly in cases of significant loss of tooth structure requiring cuspal coverage (onlays/overlays). Compared with direct restorations, indirect techniques reduced the impact of polymerization shrinkage and shrinkage stress, generally achieving a higher degree of monomer conversion and greater resistance to marginal microleakage and wear, although at the cost of more extensive tooth preparation. With the advancement of digital dentistry, indirect resin restorations could be fabricated using either subtractive manufacturing (CAD/CAM milling of prefabricated resin blocks) or, more recently, additive manufacturing (3D printing). Improvements in ceramic-filled resin formulations and in printing and post-processing protocols had expanded 3D printing from provisional to definitive restorations. Among printable materials, Crowntec (Saremco Dental AG) had demonstrated the most favorable mechanical properties reported in the literature, exceeding the minimum flexural strength threshold established by ISO 6872:2024 for monolithic single-unit restorations, although generally remaining below the values achieved by milled CAD/CAM resin blocks. Despite the increasing clinical use of 3D-printed resins, evidence on their long-term clinical performance remained scarce, particularly in comparison with CAD/CAM-milled restorations. Existing data were derived mainly from in vitro studies with heterogeneous methodologies, limiting their extrapolation to real clinical conditions, where biological aging, occlusal loading, and patient-specific factors play a determining role. Aim of the Study The study aimed to evaluate and compare the following: * The clinical performance of posterior indirect resin restorations fabricated by 3D printing (Crowntec, Saremco Dental AG) versus CAD/CAM milling (Brilliant Crios, Coltene), over a follow-up period of 36 months. * The volumetric wear of the restoration and of the antagonist tooth according to the manufacturing technique. * The effect of pulp status (vital vs. endodontically treated tooth) on the success and survival of the restorations. Study Summary A prospective, randomized, parallel-group, double-blind (participant and outcomes assessor) clinical trial is being conducted at the Clínica Odontológica of the Universitat de València (Fundación Lluís Alcanyís). Each patient provides informed consent prior to participation, and ethical approval has been obtained from the Comité Ético de Investigación en Humanos of the Universitat de València. Adult patients (≥18 years, ASA I or II) requiring a posterior indirect restoration with cuspal coverage, in either vital or endodontically treated teeth, are eligible for inclusion. Restorations are randomly assigned, in permuted blocks stratified by pulp status, to be fabricated by additive manufacturing (3D-printed resin) or subtractive manufacturing (CAD/CAM-milled resin). Standardized tooth preparations are performed under local anesthesia using cuspal-coverage preparation principles, including immediate dentin sealing for vital teeth. Intraoral digital impressions are taken, and provisional restorations are placed. Final restorations are fabricated using either 3D printing or CAD/CAM milling techniques, depending on group assignment, and are cemented using resin cement following manufacturer instructions under rubber dam isolation. Clinical evaluation is performed by a blinded outcomes assessor at baseline (1 week) and at 3, 6, 12, 18, 24, 30, and 36 months, using the revised FDI World Dental Federation criteria (Hickel et al., 2023), assessing functional, esthetic, and biological properties. Volumetric wear of the restoration and of the antagonist tooth is quantified by superimposition of successive intraoral digital scans, and restoration color change is assessed by standardized calibrated photography. An independent, blinded statistician performs the statistical analysis.

Cardiorespiratory changes during lung resection surgery, even though generally well tolerated, may lead to hemodynamic compromise, reducing venous return to the heart and hence cardiac output. Carotid corrected flow time is widely regarded as non-invasive index of preload status, yet its dynamic relationship with cardiac output, especially in surgical population is not well-studied. Understanding how cardiorespiratory changes affect carotid flow time in anesthesized patients remains limited. This study investigates corrected carotid flow time response to anesthesia, lateral position, one-lung ventilation, open chest, capnothorax, lung recruitment and volume expansion, hypothesizing that cFT declines in association with CO reduction during lung resection. The secondary interest of the study is to test whether carotid flow time and its recruitment-induced change can adequately predict fluid response during one-lung ventilation. In addition, the baseline preoperative carotid flow time and its position-induced change are studied as potential predictors of hemodynamic tolerance to lung recruitment and fluid response, respectively. Finally, the purpose of this study is to see if cardiorespiratory changes and volume expansion affect cerebral blood volume during lung resection surgery.

The goal of this clinical trial is to radiographically assess the effectiveness of minimally invasive non-surgical technique (MINST) combined with local administration of sodium hypochlorite gel (Perisolv®) and 1.6% cross-linked hyaluronic acid (HA, Hyadent BG®) compared to a neutral formulation of EDTA (Prefgel®) and enamel matrix derivative (EMD, Emdogain® FL) in periodontal regeneration. The main questions it aims to answer are: * ¿Does the combination of MINST with the local administration of sodium hypochlorite gel and 1.6% cross-linked hyaluronic acid show a potential for periodontal regeneration similar to evaluating clinical and radiographic variables compared to a neutral formulation of EDTA and enamel matrix derivative? * ¿What is the patient perception and satisfaction with the received treatment? Researchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product). The sample will be distributed according to the following treatments: * Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®. * Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL. * Control group: SRP, MINST without any bioactive product. Patients will be screened by a first visit in which they will be assigned their periodontal status. If they meet the eligibility criteria, they will be treated according to the EFP clinical guideline for periodontitis treatment: step I and step II.If the periodontal defect persists at the 12-week re-evaluation, patients will be randomised to treatment A, B or C. After the intervention, all participants will be checked weekly for the first 6 weeks to remove accumulated plaque, and every 3 months for 1 year. Periodontal parameters will be re-evaluated 6 and 12 months after periodontal regenerative intervention.

The goal of this research is to investigate oral health knowledge in pregnant women receiving care at Hospital La Fe and to see whether a one-time informational intervention improves this knowledge. The main questions this research aims to answer are: What is the level of oral health knowledge among pregnant women attending Hospital La Fe? Does a one-time informational intervention, delivered through a printed leaflet, improve oral health knowledge during pregnancy? What factors are related to differences in oral health knowledge among pregnant women? Participants are pregnant women receiving care at Hospital La Fe. They will: Complete a questionnaire about their oral health knowledge. Receive a printed informational leaflet about oral health during pregnancy. Complete the same questionnaire again after a period of time to see if their knowledge has changed. Researchers will compare answers before and after the leaflet is provided to see whether oral health knowledge improves. They will also explore which personal or social factors are linked to different levels of oral health knowledge.

Previous studies have shown that the neuroplasticity of the residual corticospinal fibers, the motor cortex and the spinal neurons plays an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology. However, it is also possible to stimulate the neuroplasticity mechanisms of these structures through techniques aimed at rehabilitating different deficits (for example, motor function or sensitivity). In general, intervention programs are usually carried out, in most cases, using low-cost strategies such as therapeutic physical exercise programs. The objective of this study is to analyze the effectiveness of visual illusion therapies in combination with conventional exercises on the symptoms and signs related to incomplete spinal cord injury that affects the upper limb. The study will include the realization of three measurements that will be carried out one day before starting the program, one day after finishing it, and one month later (follow-up). The clinical assessment will be composed of the study of the following variables: Motor function and motor skills, Upper limb isometric force, Muscle activation, Muscle tone, Quality of life, Functionality. All interventions will last eight weeks and will be planned according to the availability of volunteers. In each session, it will be recorded if any type of adverse effect occurs. There will be four types of interventions: i. Visual Illusion (IV) and therapeutic exercise program (PE), ii.placebo and PE, iii. IV, iv. IV placebo.

The general objective of this study is to evaluate the effectiveness of non-invasive neuromodulation combined with a therapeutic exercise program on neuroplasticity and, therefore, on variables related to functional capacity and quality of life, in prefrail older adults.

The objective of this clinical trial is to evaluate the impact of different torque values applied during transmucosal abutment placement in dental implants on marginal bone loss and peri-implant parameters, including the patient's perception of the treatment. The main questions the study aims to answer are: 1. Is there any difference in marginal bone loss between abutments torqued at 15 Ncm, 30 Ncm, and submerged implants without immediate transmucosal connection? 2. Are there differences in microleakage between the different torque levels? 3. How do these torque values affect peri-implant soft tissues and patient satisfaction? 4. Does the applied torque influence the patient's quality of life after the prosthetic phase? Each participant will receive three dental implants during the same surgical procedure. One of the following approaches will be applied to each implant: 1. A transmucosal abutment torqued to 15 Ncm 2. A transmucosal abutment torqued to 30 Ncm 3. A healing cap without transmucosal connection (submerged implant) After implant placement, clinical and radiographic assessments will be performed to measure marginal bone loss and peri-implant parameters.

The goal of this clinical trial is to learn if a 12-week hybrid exercise and education program (EmpowerHer) works to improve health-related quality of life in breast cancer survivors aged 35 to 65. The main questions it aims to answer are: * Does the EmpowerHer program improve the everyday quality of life of participants? * Does the program lower fatigue, anxiety, and depression while raising physical fitness? Researchers will compare the EmpowerHer program to usual medical care to see if the program works better to help survivors recover. Participants will: * Use a mobile application at home at least twice a week for structured exercise. * Read short educational modules on the mobile application about health after cancer. * Attend weekly in-person motivational group sessions with a program facilitator. * Complete health and physical tests at the start, at 12 weeks, and 3 months later.

This clinical trial aims to compare the immediate tissue response in postpartum women with and without rectus abdominis diastasis (RAD) after undergoing radiofrequency diathermy (RFD) treatment. The main question it seeks to answer is: Do postpartum women with and without RAD exhibit different acute tissue responses in terms of pressure pain threshold, superficial thermal sensitivity, and tissue elasticity? To determine whether there are differences in these acute tissue responses between the groups, researchers will compare RFD with a sham RFD intervention in postpartum women with and without RAD. Participants will receive one session of either RFD or a sham RFD intervention and will complete three assessments: one at baseline and two after the intervention, one immediately afterwards and one 20 minutes afterwards.

The aim of the present study is to investigate the effectiveness of transcranial direct current stimulation (tDCS) prior to a therapeutic eccentric exercise program on parameters related to pain and functionality in individuals with patellar tendinopathy. For this purpose, participants will be randomly divided into two groups: i) experimental group, receiving tDCS prior to a therapeutic exercise program; and ii) control group, receiving sham tDCS and a therapeutic exercise program. The interventions will last for 8 weeks. Additionally, four assessments will be conducted (baseline, week 4, week 8 and week 12). The variables studied are related to pain, functionality, muscle activity and strength, proprioception, and quality of life.

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness and improve the living with process of family caregivers of people with Alzheimer disease through multiple interventions (music therapy, health education)

This study aims to analyze the effects of an 8-week strength training program combining different exercise intensities and blood flow restriction (BFR) conditions on safety, tolerability, muscle adaptations, and physical performance variables. Three training modalities will be compared: 1) high-intensity exercise with BFR therapy; 2) low-intensity exercise with BFR therapy; and 3) high-intensity exercise without BFR therapy. All groups will perform the same exercise modality, differing only in intensity and the application of BFR. Participants will be randomly assigned to one of the three groups and will undergo a 8-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.

This study aims to analyze the effects of 4 weeks of low-intensity exercise with and without blood flow restriction (BFR) on pain, fear of movement, catastrophizing about pain, strength, and disability in a population with rotator cuff-related shoulder pain. There are two modalities corresponding to the same exercises under different blood flow restriction conditions: 1) 3 low-intensity exercises (30% 1RM) with BFR (50% AOP); 2) 3 low-intensity exercises (30% 1RM) without BFR. Participants will be randomly assigned to one of two groups and will undergo a 4-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.

This study aims to evaluate the acute effects of blood flow restriction (BFR) training on hypoalgesia and neuromuscular responses in patients with severe gonarthrosis by comparing the application of pressure with a dynamic versus a fixed configuration. There will be six different training conditions with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure; 3) 50% RM and 50% BFR with dynamic pressure; 4) 50% RM and 50% BFR with fixed pressure; 5) 30% RM and 80% BFR with dynamic pressure; 6) 30% RM and 80% BFR with fixed pressure. Each participant will complete six individual sessions under different training conditions, assigned in a random order with a 72-hour interval between each session.

This study aims to compare the acute effects on hypoalgesia of training to failure using blood flow restriction (BFR) with dynamic occlusion versus BFR with fixed occlusion in patients with severe gonarthrosis. Two different training conditions will be performed with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure. Each participant will complete two individual sessions under different training conditions, randomly assigned with a 72-hour interval between sessions.

This study aims to compare the acute effects at the cardiovascular (heart rate, blood pressure) and physiological (lactate) levels, as well as the perception of effort and fatigue, of four exercise modalities, one based on the traditional aerobic training methodology, another based on high-intensity interval training (HIIT), another consisting of aerobic exercise performed in conjunction with an immersive virtual reality (VR) application, and a last one consisting of exercise with HIIT-type parameters but also performed in conjunction with an immersive VR application. All participants will complete one session of each of the four exercise modalities, analyzing the variables studied in each for subsequent analysis and comparison.

The goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation. The main questions it aims to answer are: * Is there any difference in marginal bone loss for different abutment shapes and heights? * Do the shape and height of the abutment affect implant success? All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients: 1. 2-mm high abutments with cylindrical shape. 2. 2-mm high abutments with concave shape. 3. 3-mm high abutments with cylindrical shape. 4. 3-mm high abutments with concave shape. Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.

This prospective clinical study aims to evaluate the clinical efficacy of an at-home dental bleaching protocol and its impact on oral health-related quality of life using objective color measurements and patient-reported outcomes. Changes in tooth color will be assessed using CIELAB parameters (L\*, a\*, b\*) and the Whiteness Index for Dentistry (WID), while quality of life will be evaluated using the OHIP-14 questionnaire.

The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers. The overarching objective of the present project is to assess the influence of the nature and method of application of the materials under study on tissue response, the reduction of pressure on the sole of the foot, and the healing of neuropathic ulcers in patients with diabetes mellitus.

Introduction. Distasis rectus abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. Some authors describe a prevalence of 40% in women up to one year postpartum. Some studies suggest that the presence of DRA can be related to the appearance of low back, pelvic and abdominal pain and even urinary incontinence. These factors can significantly affect the quality of life of women with diastasis both socially, sexual and personal level. According to several studies, this pathology is related to higher rates of depression and an alteration in the self-perception of body image that makes these women to look to specialized medical care. At present, the quantitative evaluation of DRA is performed purely anatomically. This evaluation consists in measuring the separation between the two rectus abdominis. Currently there is no consensus as to the protocol that should be used for this measurement. So far, no instrument is able to quantitatively measure the consequences of DRA. The evaluation of symptoms and consequences should include relevant parameters such as quality of life, perception of body image and functional limitations. The objective of this study is the creation and validation of a specific questionnaire to evaluate the symptoms and consequences of DRA. Material and methods. A) Development of the questionnaire 1. Literature review 2. Online survey 3. Expert panel 4. Pilot test of the questionnaire B) Validation of the questionnaire. The psychometric properties of the questionnaire will be evaluated in a sample of patients with DRA. The sample will be composed of a group of adult women with DRA who attended to a physiotherapy clinic.

Your study seems to aim at emphasizing the significance of non-pharmacological and non-hormonal approaches in managing menopausal symptoms, particularly focusing on muscle training and education. This holistic approach acknowledges the importance of physical well-being, psychological support, and education to enhance women's quality of life during the menopausal transition.

This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program. The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.

The intervention program targets adolescents between 12 and 16 years of age. The intervention program is designed for adolescents during a critical developmental stage marked by significant life transitions, where building strong personal resources and receiving psychological support is essential to foster socioemotional skills and overall well-being. The serious game aims to promote psycho-emotional health in the general adolescent population, supporting healthy development and preventing future emotional difficulties. At the same time, it incorporates specific modules for adolescents living with chronic conditions such as asthma, food allergy, type 1 diabetes, and allergic rhinitis, who may face additional risks of psychological challenges that can complicate treatment and prognosis. By combining universal health promotion with tailored support, the program addresses both the needs of healthy adolescents and those with chronic illnesses. The platform integrates digital and technological tools for dynamic and personalized intervention. Artificial intelligence adapts activities and feedback to each participant's socio-demographic profile and evolving needs, this supports directly in participants' daily lives and natural environments, making the experience more relevant and impactful. The serious game, proven effective in engaging young people, goes beyond traditional psychoeducation by creating an interactive environment where adolescents develop socio-emotional competencies, resilience, and health-related knowledge. Through its six thematic areas, the game promotes overall well-being and healthy habits, while its condition-specific modules provide targeted guidance and coping strategies for asthma, food allergies, type 1 diabetes, and allergic rhinitis.