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NCT ID: NCT05569525 Not yet recruiting - Diabetes Clinical Trials

Type I Diabetes and Non-surgical Periodontal Treatment

Start date: November 6, 2022
Phase: N/A
Study type: Interventional

Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Literature about the correlation between periodontitis and type 1 diabetes is scarce, since no randomized clinical trials have been performed. The objective of the present clinical investigation is to evaluate the effects of nonsurgical treatment of periodontal disease on glycemic variability in patients with type 1 diabetes (T1DM). The hypothesis is that nonsurgical periodontal therapy affects glycemic variability in terms of time spent in hyperglycemia.

NCT ID: NCT05562596 Not yet recruiting - Clinical trials for Cognitive Impairment

Normal Pressure Hydrocephalus Biomarkers Investigation

NORPHY
Start date: October 30, 2022
Phase:
Study type: Observational

Normal Pressure Hydrocephalus (NPH) is a clinical condition that induces cognitive deterioration that can be reverted, at least in part, by introducing ventricular-peritoneal diversion controlled by a miniaturized valve system. Mechanisms involved in such an improvement of cognitive function after liquor diversion are unknown. Oxysterols are a family of cholesterol-related compounds having diverse biological functions. Among others, they are involved in cholesterol homeostasis in the brain and are detectable in liquor, potentially impacting neurodegeneration. NPH is an ideal clinical model to study oxysterol distribution in liquor before and after ventricular-peritoneal diversion.

NCT ID: NCT05559424 Not yet recruiting - Clinical trials for Ischemic Heart Disease

Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting

CRABBIS
Start date: October 2022
Phase: N/A
Study type: Interventional

Single-stent strategy with provisional approach represents the gold standard for percutaneous coronary intervention of bifurcation lesions, and, according to European Bifurcation Club, performing provisional approach presents two steps considered as mandatory: "crossover stenting" in main vessel (MV) and subsequent post-dilation or "POT" (proximal optimization technique). While consensus exists regarding these first two steps, the exact optimal following sequence in case of side branch (SB) jeopardize after main vessel stenting is still a matter of debate. Actually, the two most used techniques in this setting are represented by the simultaneous inflation of two balloons located respectively in the MV and SB followed by a second POT (POT/kissing balloon/POT technique) and the isolated inflation of a balloon placed in the SB followed by a second POT (POT/SIDE/POT technique). The objective of this study is to compare the configuration achieved with POT/KISS/POT (PKP) and POT/SIDE/POT (PSP), using the "cutting edge" high-resolution intracoronary imaging modality (Optical Coherence Tomography, OCT).

NCT ID: NCT05556499 Not yet recruiting - Osteoporosis Clinical Trials

The Bone-parathyroid Crosstalk in Primary Hyperparathyroidism

PARABONE
Start date: October 2022
Phase:
Study type: Observational

The PARABONE study aims to investigate the interaction between bone and parathyroid glands in patients with primary hyperparathyroidism (HPT). The study consists of a clinical part aimed at evaluating a series of circulating molecules of bone derivation (osteocalcin, molecules of the WNT pathway, RANKL, osteoprotegerin, Scelrostin, FGF23) in patients with HPT. In particular, the study has as its primary objective to identify the correlation between circulating levels of PTH and levels of GlaOC and GluOC in patients with HPT.

NCT ID: NCT05485831 Not yet recruiting - Dravet Syndrome Clinical Trials

Epidyolex® in Lennox Gastaut and Dravet Syndrome: an Observational Study in ITALY

EpiTALY
Start date: June 23, 2024
Phase:
Study type: Observational

This is a prospective, observational study on approximately 70 Real World participants affected by LGS or DS, treated with Epidyolex® as prescribed in the summary of product characteristics. The eligible participants are expected to participate in the study for a duration of 56 weeks of treatment.

NCT ID: NCT05484102 Not yet recruiting - Children, Only Clinical Trials

Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children

FERCT19
Start date: September 15, 2022
Phase: N/A
Study type: Interventional

this is a double-blind randomized placebo controlled clinical trial. 200 healthy children aged 12-48 months, attending day care or preschool for at least 5 days a week, regularly checked by the family pediatrician (FP) involved in the trial, were considered for the study and consecutively contacted during scheduled medical examinations at the FPs office. study plan is 3-month treatment period. The clinical evaluation will be carried out at enrollment, at 30, 60 and 90 days from the beginning of the treatment by the pediatrician. fecal and nasal mucus samples for immunological and microbiological analysis will be collected before the treatment and at 90 days (end of treatment).

NCT ID: NCT05482490 Not yet recruiting - Implant Infection Clinical Trials

Maintenance Protocol for Implant Supported Hybrid Prosthesis.

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The study we intend to carry out aims to analyze the clinical and microbiological effects of a new maintenance protocol for implant-supported hybrid prostheses. The maintenance protocol we propose is based on a sequence of phases that include not only the hygiene and cleaning of the prosthesis and the implants, but also the motivation and reinforcement of oral hygiene through iconographic aid (intraoral photographs of the patient). The proposed hygiene protocol is based on a meticulous preliminary plaque disclosure, followed by a full mouth decontamination of all intraoral mucosae, a decontamination of the secondary components, specific intrasulcular decontamination of the implants depending on whether there are probes greater than or less than 5mm and finally, a decontamination and hygiene of the hybrid prosthesis, all with the help of erythritol powders and the different settings of the AirFlow Prophylaxis Master EMS (Electro Medical Systems S.A., Nyon, Switzerland) device. Clinical parameters such as plaque index (PlI), probing depth (PD), bleeding on probing (BOP) and peri-implant suppuration (PS) will be recorded immediately after removal of the prosthesis and at one month of follow-up. The collection of the microbiological sample will be carried out according to the following procedures: the implant will be isolated by suction and the use of cotton rolls, in order to avoid contamination of saliva. Four sterile endodontic paper points will be inserted into the peri-implant sulcus of each implant, placing them in the mesial, distal, lingual/palatal and buccal sites and removed after 30 seconds with tweezers by placing them in a sterile plastic tube which will be sealed immediately. The same procedure will be performed for each implant. Once the operation is completed, the tubes of each patient (one for each implant and each containing 4 paper points) will be sent for microbiological analysis. The samples will be sent to the Microbiology Laboratory of the Department of Surgical Sciences of the University of Cagliari, in order to analyze the presence of bacteria ofn the peri-implant sulci. DNA from crevicular fluid samples will then be isolated by centrifugation and analyzed by PCR (polymerase chain reaction). This biomolecular technique is based on an enzymatic reaction, in which a heat-resistant DNA polymerase (Taq Polymerase) catalyzes the specific amplification of known DNA sequences. This procedure will be performed before the hygiene protocol, immediately after and at one month of follow-up. Power analysis was employed to determine the sample size by using a .05 significance level and a power of 90% based on an effect size of 0.25. Sample size of a minimum of 130 implants (approximately 25/30 patients carrying implant supported hybrid prostheses) is required to detect significant difference between the parameters measured at the different time points using repeated measures ANOVA, however the recruitment of patients will continue through the entire first period of the execution program with no limitations even after reaching the predetermined number

NCT ID: NCT05481580 Not yet recruiting - Furcation Defects Clinical Trials

Restorations and Furcation Involvement on Molars

Start date: September 1, 2022
Phase:
Study type: Observational

The aim of this study will be to analyze the relationship between the presence of second class restorations (interproximal fillings) or prostheses (crowns, bridges) on molar teeth and the presence of bone resorption between the roots of the latter. Patients with this type of restorations will be identified and a non-interventional clinical and radiographic analysis will be conducted.

NCT ID: NCT05481567 Not yet recruiting - Periodontitis Clinical Trials

Periodontitis Stage III and IV and Oral Health Related Quality of Life

Start date: September 1, 2022
Phase:
Study type: Observational

Patients diagnosed with stage III or IV periodontitis during routine visits at the department of periodontology will undergo a validated questionnaire to understand the impact of the disease on their quality of life.

NCT ID: NCT05477017 Not yet recruiting - Type2Diabetes Clinical Trials

Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients

SOLDMiDiab02
Start date: September 2022
Phase:
Study type: Observational

The aim of the study is to evaluate the benefits, documented in experimental settings, of treatment with SGLT2-i in subjects with type 2 diabetes and older than 70 years in normal clinical practice. The type of study does not involve immediate risks or direct benefits for the subjects taking part in it. The potential benefits for clinicians and healthcare systems are: greater knowledge of diabetic disease and the study of new treatment options. However, the analysis of the data will allow us to better identify which patients benefit most from treatment with glycosurics.