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NCT ID: NCT06365983 Recruiting - Gingival Recession Clinical Trials

Comparison of Free Gingival Graft and Linear Incision for Connective Tissue

Start date: April 28, 2023
Phase: N/A
Study type: Interventional

A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side. Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush. All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques. Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis. INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions. EXCLUSION CRITERIA Individuals will not be considered eligible if they: - Present any form of immunological compromise; - Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases; - Present active periodontitis, defined by presence of >=10% subgingival bleeding and probing depth and clinical attachment loss proximal >4mm (Tonetti et al. 2018); - Are current or ex-smokers; - Have allergies to ibuprofen and chlorhexidine digluconate. Research Objective: PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage. SECONDARY OBJECTIVE Compare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes.

NCT ID: NCT06365528 Not yet recruiting - Clinical trials for Deep Vein Thrombosis

Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.

NCT ID: NCT06365021 Recruiting - Bipolar Disorder Clinical Trials

ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the efficacy of Acceptance and Commitment Therapy (ACT) as a psychotherapeutic treatment for patients with Bipolar Disorder (BD). The following questions will be investigated: - The efficacy of ACT in reducing depressive symptoms in patients with BD. - The efficacy of ACT in improving the quality of life in patients with BD. - The efficacy of ACT in improving functionality in patients with BD. - The efficacy of ACT in improving sleep quality in patients with BD. - The efficacy of ACT in improving psychological flexibility in patients with BD Participants in the clinical group will undergo 12, 2 hours, weekly sessions of Acceptance and Commitment Therapy, in addition to their regular pharmacological treatment. Participants in the control group will undergo 3, 2 hours, weekly sessions of Bipolar Disorder Psychoeducation Therapy, in addition to their regular pharmacological treatment. Scales and assessments will be used to measure study outcomes on 3 different time-points: pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). Mood scales will be assessed every 2 weeks for the duration of treatment and every 4 weeks during the additional 12 week follow-up period. Psychological Flexibility scale will be assessed every week for the duration of treatment; as well as brief mood diary, which will be assessed daily for the duration of treatment. Results will be compared among both groups to assess the effectiveness of Acceptance and Commitment Therapy as an intervention for syndromic and sub-syndromic depression in bipolar disorder.

NCT ID: NCT06363656 Recruiting - Insomnia Clinical Trials

Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol

SLEEP-EX2
Start date: February 15, 2024
Phase:
Study type: Observational

The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality. The main question it aims to answer is: - Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep?

NCT ID: NCT06362499 Recruiting - COVID-19 Clinical Trials

Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients.

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea, fatigue, chest pain and palpitations. The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment. In many of these patients, tachypnea at low levels of exertion suggests increased respiratory muscle activity, which can lead to the sensation of dyspnea. Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise. In this way, inspiratory muscle training can improve symptoms (dysfunctional breathing), possibly by attenuating the metaboreflex (vagal modulation-attenuation of the sympathetic response) of the inspiratory muscle in post-covid-19 subjects, reducing ventilatory variability.

NCT ID: NCT06357533 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

TROPION-Lung10
Start date: April 11, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

NCT ID: NCT06356129 Not yet recruiting - Clinical trials for Large B-cell Lymphoma

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

GOLSEEK-1
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

NCT ID: NCT06355882 Recruiting - Clinical trials for Low Cardiac Output Syndrome

Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia

Start date: August 8, 2023
Phase: N/A
Study type: Interventional

Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed

NCT ID: NCT06354439 Recruiting - Ectopic Pregnancy Clinical Trials

Use of Letrozole for Ectopic Pregnancy

EcZOL
Start date: March 27, 2024
Phase: Phase 4
Study type: Interventional

A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate

NCT ID: NCT06350123 Recruiting - Clinical trials for Chronic Kidney Disease

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease.

MIRO-CKD
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.