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Aim To compare need for bone augmentation, surgical complications, periodontal, radiographic, aesthetic and patient reported outcomes in subjects receiving implant placement at the time of extraction (Immediate Implant) or 12 weeks thereafter. Methods Subjects requiring single tooth extraction in the anterior and premolar areas were recruited in seven private practices. Implant position and choice of platform were restoratively driven. Measurements were performed by calibrated and masked examiners. Results IMI was unfeasible in 7.5% of cases. One hundred and 24 subjects were randomized. One implant was lost in the IMI group. IMI required bone augmentation in 72% of cases compared with 43.9% for delayed ( p = 0.01), while wound failure occurred in 26.1% and 5.3% of cases, respectively ( p = 0.02). At 1 year, IMI had deeper probing depths (4.1 ± 1.2 mm versus 3.3 ± 1.1 mm, p < 0.01). A trend for greater radiographic bone loss was observed at IMI over the initial 3-year period ( p-trend < 0.01). Inadequate pink aesthetic scores were obtained in 19% of delayed and in 42% of IMI implant cases ( p = 0.03). No differences in patient reported outcomes were observed. Conclusions Immediate implant placement should not be recommended when aesthetics are important, IMI should be limited to selected cases. Longer follow-up is needed to assess differences in complication rates. [ABSTRACT FROM AUTHOR]

Objectives: to examine the factors that, in the context of the current pandemic, have influenced the conduct of a randomized clinical trial on hydroxychloroquine in Italy., Design: the trend of enrolment in the PROTECT study, "A randomized study with Hydroxychloroquine versus observational support for prevention or early phase treatment of Coronavirus disease (COVID-19)" (Eudract number: 2020-001501-24, NCT04363827), conducted in the period from May to September 2020, was analysed to evaluate the possible association of the enrolment rate with the amount of information published in the national and local press on hydroxychloroquine., Setting and Participants: the PROTECT clinical study is an Italian interventional superiority study, open label, with cluster randomization, aimed at evaluating whether treatment with hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in a population of subjects exposed to SARS-CoV-2 virus consisting of cohabitants/contacts of COVID-19 patients and asymptomatic or paucisymptomatic subjects diagnosed with COVID-19., Main Outcome Measures: the number of asymptomatic or paucisymptomatic COVID-19 patients and the number of contacts/cohabitants of COVID-19 patients enrolled in the Protect study from May to September 2020., Results: from May to September 2020, the number of patients diagnosed with COVID-19 enrolled in the PROTECT clinical trial showed a decrease consistent with the number of news on hydroxychloroquine appearing in the national and local press, starting from the time when the first criticisms of the efficacy of hydroxychloroquine were made known; the number of contacts/cohabitants of COVID-19 patients showed a more marked and more timely decrease., Conclusions: in the context determined by the current COVID-19 pandemic, conducting a controlled clinical trial is strongly influenced by public opinion on scientific issues. Adherence to a clinical study can become highly problematic and invalidate the possibility of answering a scientific question and the validity of a project. In the current pandemic situation, randomized controlled trials may not always be the optimal tool to reach the expected scientific evidence, due to a number of problems. It is preferable to use a sequential or adaptive design. Furthermore, study protocols should implement innovative approaches that also include the involvement of participants in the decision-making process. In any case, the influence of public information on scientific issues is an extremely important factor to consider in the design of clinical trials in exceptional situations such as a pandemic., Competing Interests: None declared