Browsing by Subject "Randomized controlled trial"

Now showing 1 - 3 of 3
  • Repository logo
    Publication
    Open Access
    DATA SET HELPeN Project Reducing Loneliness
    (2026-03-10) Hernández López, María Jesús; García González, Jessica; Leal Costa, César; Ramos Morcillo, Antonio Jesús; Díaz García, Isidora; López Pérez, María Verónica; Hernández Méndez, Solanger; Ruzafa Martínez, María; Enfermería; Facultad de Enfermería
  • Thumbnail Image
    Publication
    Open Access
    Histological and immunohistochemical soft-tissue response to cylindrical and concave abutments: multicenter randomized clinical trial
    (Wiley, 2024-08-26) Camacho Alonso, Fabio; Bernabeu Mira, Juan Carlos; Mercado Díaz, Ana María; Pérez Sayans, Mario; Pérez Jardón, Alba; Somoza Martín, José Manuel; Montero, Javier; Gómez Polo, Cristina; Quispe López, Norberto; Peñarrocha Oltra, David; Buendía Marín, Antonio Julián; Sánchez Campillo, Joaquín; Dermatología, Estomatología, Radiología y Medicina Física
    Background:This study aimed to analyze the influence of concave andcylindrical abutments on peri-implant soft tissue. Dimensions, collagen fiberorientation, and immunohistochemical data were assessed.Methods:A multicenter, split-mouth, double-blind randomized clinical trialwas conducted. Two groups were analyzed: cylindrical abutments and concaveabutments. After a 12-week healing period, peri-implant soft tissue samples werecollected, processed, and evaluated for dimensions, collagen fiber orientation,and immunohistochemical data. Inflammatory infiltration and vascularizationwere assessed, and the abutment surfaces were analyzed using scanning elec-tron microscopy. The statistical analysis was performed using the SPSS version20.0 statistical package.Results:A total of 74 samples in 37 patients were evaluated. Histologicalevaluation of peri-implant soft tissue dimensions revealed significant differ-encesbetweenconcaveandcylindricalabutments.Concaveabutmentsexhibitedgreater total height (concave: 3.57±0.28 – cylindrical: 2.95±0.27) and bar-rier epithelium extension (concave: 2.46±0.17 – cylindrical: 1.89±0.21)(p<0.05),whilethesupracrestalconnectivetissueextension(concave:1.11±0.17– cylindrical: 1.03±0.16) was slightly greater (p>0.05). Collagen fiber ori-entation favored concave abutments (23.76±5.86), with significantly moretransverse/perpendicular fibers than for cylindrical abutments (15.68±4.57).The immunohistochemical analysis evidenced greater inflammatory and vascu-lar intensity in the lower portion for both abutments, though concave abutmentsshowed lower overall intensity (concave: 1.05±0.78 – cylindrical: 1.97±0.68) (p<0.05). The abutment surface analysis demonstrated a higher percentage oftissue remnants on concave abutments (42.47±1.32; 45.12±3.03) (p<0.05).Conclusions:Within the limitations of this study, concave abutments pre-sented significantly greater peri-implant tissue height, linked to an extendedbarrier epithelium, versus cylindrical abutments in thick tissue phenotype.This enhanced soft tissue sealing, favoring a greater percentage of transverselyoriented collagen fibers. The concave design reduced chronic inflammatoryexudation with T and B cells, thus minimizing the risk of chronic inflammation.
  • Thumbnail Image
    Publication
    Open Access
    Reducing loneliness and social isolation through the HELPeN telephone-call program: results from a randomized controlled trial in older adults living in the community
    (MDPI, 2026) Hernández López, María Jesús; García González, Jessica; Leal Costa, César; Ramos Morcillo, Antonio Jesús; Díaz García, Isidora; López Pérez, María Verónica; Hernández Méndez, Solanger; Ruzafa Martínez, María; Enfermería; Facultades de la UMU::Facultad de Enfermería
    Background/Objectives: Loneliness is a significant public health issue among older adults, especially in rural and socioeconomically vulnerable groups. Telephone-based interventions have become a scalable, cost-effective way to reduce social isolation, although evidence of their long-term effects on various health outcomes remains limited. This study aimed to assess how effective HELPeN, a structured telephone program delivered by trained nursing students, is in decreasing loneliness and enhancing psychosocial and cognitive health in community-living older adults. Methods: A randomized controlled trial was conducted with 119 older adults (≥65 years) residing in the community. Participants were allocated to either an intervention group (n = 65), which received weekly structured telephone calls over 9 months, or a control group (n = 54), which received standard care. Outcomes were evaluated at baseline (M0), mid-intervention (M1–M3), and 3 months after the intervention (M4). The primary outcomes measured included loneliness and perceived social support. Secondary outcomes comprised functional status, comorbidities, depressive symptoms, quality of life, sleep quality, and cognitive function. The data were analyzed using repeated-measures ANOVA with Greenhouse–Geisser correction. Results: Significant group interactions over time were identified for loneliness (F = 5.92, p = 0.001, η2 = 0.067), social support (F = 3.39, p = 0.023, η2 = 0.043), depressive symptoms (F = 3.87, p = 0.019, η2 = 0.046), and cognitive status (F = 5.35, p = 0.002, η2 = 0.063). No significant differences were found for functional status, comorbidity, sleep quality, or quality of life. Conclusions: The HELPeN program demonstrated significant effectiveness in reducing loneliness and social isolation, and in improving emotional, cognitive, and sleep-related outcomes in older adults. As a low-cost and scalable model, this intervention strengthens the role of nursing students in addressing social determinants of health and may be integrated into community and public health strategies targeting vulnerable aging populations.