Good clinical practice in clinical interventional studies

Pieterse, Herman; Diamant, Zuzana

doi:10.3402/ecrj.v1.26422

Cited by 10 publications

(7 citation statements)

References 1 publication

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“…Institutional Review Board (IRB) approval was obtained from the University of Maryland and The University of Iowa (HP‐00068397 and HawkIRB #201301766, respectively). The study was conducted and monitored in accordance with the Helsinki Declaration of 1975, as revised in 2000, and the principles of Good Clinical Practice 19 . This trial was registered at http://www.clinicaltrials.gov under code NCT02702609.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of poly lactic‐co‐glycolic acid‐coated β‐tricalcium phosphate for alveolar ridge preservation: A multicenter randomized controlled trial

Saito

Couso‐Queiruga

Shiau

et al. 2020

Journal of Periodontology

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Background Alveolar ridge preservation via socket grafting (ARP‐SG) is indicated to attenuate physiologic alveolar bone resorption as a consequence of tooth extraction. However, a specific bone grafting material that is patently superior has not been identified yet. The aim of this randomized controlled trial was to evaluate the efficacy of a moldable alloplastic graft, Poly Lactic‐Co‐Glycolic Acid‐Coated β‐Tricalcium Phosphate (PLGA‐β‐TCP), for ARP purposes [Group A] compared to freeze‐dried bone allograft (FDBA) particles covered with a rapidly absorbable collagen dressing (RACD) (Group B) in function of a panel of radiographic, histomorphometric, and implant‐related outcomes. Methods Patients in need of extraction of a single posterior tooth (premolar or molar) and subsequent replacement with a dental implant were recruited and randomly allocated into one of the two treatment groups. Follow‐up visits took place at 1, 2, 4, 8, and 16 weeks. Cone‐beam Computed Tomography (CBCT) scans were obtained at baseline and at 16 weeks. Sites were re‐entered at 20 weeks for bone core biopsy harvesting and subsequent implant placement. After delivery of the final implant‐supported restoration, follow‐up visits were scheduled at 6 and 12 months to monitor peri‐implant tissue health and marginal bone levels using standardized intraoral periapical radiographs. Results A total of 45 patients were initially enrolled in the study, of whom 43 received an implant and 32 completed the study. Healing was uneventful in all sites after ARP‐SG and implant placement. No site required bone augmentation to allow for implant placement. CBCT scan analyses showed no statistically significant differences between groups in terms of reduction of horizontal width, midbuccal / midlingual height and ridge volume. Histomorphometric assessments revealed a statistically significant difference between both groups in terms of mineralized tissue formation (Group A = 27.0% ± 22.1% versus Group B = 38.2% ± 12.5%; P < 0.05). On the contrary, no significant differences were observed regarding percent of remaining bone grafting material and non‐mineralized tissue. No implant failed throughout the study period and marginal bone level change was negligible in both groups. Conclusions Although a higher proportion of mineralized tissue was associated with the use of FDBA+RACD compared to PLGA‐β‐TCP alone, both ARP‐SG approaches rendered comparable outcomes in terms of maintenance of alveolar bone dimensions, feasibility of implant placement, implant survival, and peri‐implant bone level stability up to 12 months post‐loading.

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Section: Methodsmentioning

confidence: 99%

Evaluation of poly lactic‐co‐glycolic acid‐coated β‐tricalcium phosphate for alveolar ridge preservation: A multicenter randomized controlled trial

Saito

Couso‐Queiruga

Shiau

et al. 2020

Journal of Periodontology

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“…O estudo foi projetado de acordo com paradigmas epidemiológicos clínicos contemporâneos e seguindo os padrões do Good Clinical Pratice 14 . Os resultados deste estudo devem ser considerados na perspectiva do seu desenho experimental, que visava verificar a diferença entre grupos de diferentes sexo e faixas etárias.…”

Section: Discussionunclassified

Sexo e idade como fatores modificadores na remoção do biofilme supragengival

Severo¹,

Muniz

Oballe³

et al. 2019

R. Fac. Odontol. Porto Alegre

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Objetivo: Este trabalho objetivou avaliar a capacidade de remoção do biofilme de acordo com o sexo e a idade. Materiais e métodos: Setenta indivíduos com idades entre 21 e 70 anos foram incluídos. Índice de Placa Modificado da Marinha (IPMM) foi realizado por um examinador calibrado. Em seguida, eles escovaram seus dentes com uma escova macia por um minuto, e o IPMM foi novamente aplicado. Os voluntários utilizaram a escova durante sete dias, duas vezes ao dia, com dentifrício padronizado. Após sete dias, os mesmos procedimentos da primeira visita foram realizados. Os percentuais de remoção de biofilme supragengival (boca inteira, interproximal e da linha da gengival) foram calculados em cada um dos períodos experimentais. Comparações foram realizadas entre os sexos e idade com o uso de teste-t para amostras independentes. O nível significância adotado foi de 5%. Resultados: Na consulta inicial e após 7 dias, mulheres apresentaram maior quantidade de placa na boca toda que homens (p 37 anos (p

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“…The NASA study followed the principles of Good Clinical Practice [ 30 ], the Declaration of Helsinki V, and the Danish legislation. A standard protocol of quality control was established for this study.…”

Section: Methodsmentioning

confidence: 99%

Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission

Zheng

Huang

et al. 2021

Rheumatol Ther

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Introduction In recent axSpAx patients with remission lasting at least 3 months and later followed-up monthly for a median of 8 months, we compared the predictive value of baseline MRI of sacroiliac joints and constructed a nomogram model for predicting flare. Methods This study included 251 patients with axial spondyloarthritis, according to the ASAS axSpA classification criteria, who achieved Low Disease Activity (ASDAS) and underwent MRI examination. A total of 144 patients from the First Affiliated Hospital of Xiamen University were used as the nomogram training set; 107 from the First Affiliated Hospital of Fujian Medical University were for external validation. Results The median time of relapse was 8.705 months (95% CI 8.215–9.195) and 7.781 months (95% CI 7.075–8.486) for MRI-positive patients and 9.8 months (95% CI 9.273–10.474) for MRI negative patients, respectively. Both active sacroiliitis on MRI (HR 1.792, 95% CI 1.230–2.611) and anti-TNF-α treatments (HR 0.507, 95% CI 0.349–0.736) were significantly associated with disease flares. Gender, disease duration, HLA-B27, MRI, and anti-TNF-α treatment were selected as predictors of the nomogram. The areas under the ROC curve (AUROCs) of the 1-year remission probability in the training and validation groups were 0.71 and 0.729, respectively. Nomogram prediction models present better AUROCs, C-indices, and decision curve analysis cure than the clinical experience model. Conclusions Active sacroiliitis in MRI requires weighting in order to estimate remission and disease flares, when axSpA patients achieve low disease activity. The simple nomogram might be able to discriminate and calibrate in clinical practice. Trial registration ClinicalTrials, NCT03425812, Registered 8 February 2018, https://clinicaltrials.gov Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00279-y.

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Good clinical practice in clinical interventional studies

Cited by 10 publications

References 1 publication

Evaluation of poly lactic‐co‐glycolic acid‐coated β‐tricalcium phosphate for alveolar ridge preservation: A multicenter randomized controlled trial

Evaluation of poly lactic‐co‐glycolic acid‐coated β‐tricalcium phosphate for alveolar ridge preservation: A multicenter randomized controlled trial

Sexo e idade como fatores modificadores na remoção do biofilme supragengival

Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission

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