Risk Management for a Legally Valid Informed Consent.

ABSTRACT: Gelli-Bianco law (Law no. 24/2017) intervenes both in order to divide healthcare liability between the healthcare professional and the facility in which he/she exercises and to incentivize the latter to adopt an organizational model suitable for managing the risk associated with the provision of any healthcare service, including the information for consent. In fact, the healthcare facility must guarantee clear, complete and adequate information on the specific case, which, therefore, cannot consist of standard forms to be signed by the patient, under penalty of a flawed consent to treatment and consequent healthcare liability in the event of an adverse event. The regulation mandates that safety must be guaranteed through proper prevention tools and health care risk management, in con-junction with the most effective use of structural, technological and organizational resources available. It further spells out the obligation of health care professionals to contribute to risk prevention while administering health care procedures. For this reason, the consent information constitutes a source of risk for the responsibility of the healthcare provider and the Facility and it must necessarily be managed. Risk Management is the management tool that can allow the healthcare facility to improve the quality and safety of the services provided, optimizing the risk of adverse events through proper moni-toring of the same. This paper will be published, following a special agreement, on the two journals "Igiene e Sanità Pubblica" and "La Clinica Tera-peutica", in Italian and in English, in order to increase the diffusion to a wider audience.

Tenosynovial complications identify TTR cardiac amyloidosis among patients with hypertrophic cardiomyopathy phenotype.

Recent evidence suggests that carpal tunnel syndrome (CTS) and brachial biceps tendon rupture (BBTR) represent red flags for ATTR cardiac amyloidosis (ATTR-CA). The prevalence of upper limb tenosynovial complications in conditions entering differential diagnosis with CA, such as HCM or Anderson-Fabry disease (AFD), and hence their predictive accuracy in this setting, still remains unresolved. OBJECTIVE: To investigate the prevalence of CTS and BBTR in a consecutive cohort of ATTR-CA patients, compared with patients with HCM or AFD and with individuals without cardiac disease history. PARTICIPANTS: Consecutive patients with a diagnosis of ATTR-CA, HCM and AFD were evaluated. A control group of consecutive patients was recruited among subjects hospitalized for noncardiac reasons and no cardiac disease history. The presence of BBTR, CTS or prior surgery related to these conditions was ascertained. RESULTS: 342 patients were prospectively enrolled, including 168 ATTR-CA (141 ATTRwt, 27 ATTRm), 81 with HCM/AFD (N = 72 and 9, respectively) and 93 controls. CTS was present in 75% ATTR-CA patients, compared with 13% and 10% of HCM/AFD and controls (P = 0.0001 for both comparisons). Bilateral CTS was present in 60% of ATTR-CA patients, while it was rare (2%) in the other groups. BBTR was present in 44% of ATTR-CA patients, 8% of controls and 1% in HCM/AFD. CONCLUSIONS: CTS and BBTR are fivefold more prevalent in ATTR-CA patients compared with cardiac patients with other hypertrophic phenotypes. Positive predictive accuracy for ATTR-CA is highest when involvement is bilateral. Upper limb assessment of patients with HCM phenotypes is a simple and effective way to raise suspicion of ATTR-CA.

Knowledge of Emergency Management of Avulsed Teeth among Italian Dentists-Questionnaire Study and Next Future Perspectives.

(1) Background: In Italy, about one fourth of all schoolchildren experience a trauma to the permanent dentition. Management of avulsion trauma is challenging and requires adherence to clinical protocols. The aim of this study was to investigate the management knowledge of avulsed teeth among Italian dentists and to promote the guidelines' dissemination through the use of new social media. (2) Methods: The survey was carried out during the COVID-19 lockdown in Italy (March-May 2020). The questionnaire was sent anonymously to a total of 600 dentists. The questionnaire consisted of two parts. Part A-demographic and professional data and Part B-management of traumatic avulsion. (3) Results: The response rate was 50.6% and the mean fraction of correct responses was 0.524. Issues related to the therapeutic management of avulsed teeth were shown to be not well understood by the respondents. Professionals with qualifications in dentistry and those who declared to know the guidelines responded better, while other demographic and professional factors were insignificant. (4) Conclusions: Italian dentists' knowledge of the management of avulsion trauma should be improved. Educational programs and campaigns must be undertaken to improve their awareness and adherence to the Italian and international guidelines.

Risk management and Healthcare responsibility. How to guarantee legal protection in Medicine.

Having regard to the increasing attention to the issue of safety and health of patients and workers by low, the hypothesis that this topic will be the growing trend in the next years does not seem to be manifestly unfounded. For this reason, it is wise for healthcare professionals to already be aware that any violation of the interests underlying the legislation in question entails a ruling on civil and/or criminal liability. It is therefore necessary to identify the most suitable means to prevent undue harm occurring, partly to exempt healthcare professionals and hospitals from compensation costs, thereby providing them with recourse to insurance coverage. Healthcare facility organisations must adopt Risk Management techniques as a tool to simultaneously guarantee the effectiveness of health services (in this case), the efficiency of the management economy, and finally compliance with all legally required precautions. This will relegate the occurrence of an adverse event to remote and unpredictable hypotheses, thus guaranteeing useful recourse to insurance coverage to compensate any harm that does occur.

Challenges in diagnosing and managing non-cavitated occlusal caries lesions. A Literature overview and a report of a case.

AIM: Aim of this literature overview was to analyze the diagnostic procedures of hidden caries lesions and to present a restorative protocol. METHODS: A literature overview was performed in order to evaluate hidden caries etiological hypothesis and the reported prevalence. The diagnostic procedure is performed with the aid of an intra-oral fluorescence based camera and the restorative procedure is completed with the use of a novel bisphenol-A free composite. RESULTS: Non cavitated occlusal caries lesions prevalence is high in young adults population. Diagnosis of hidden caries requires both high sensitivity and specificity. CONCLUSIONS: The novel diagnostic and restorative protocol showed to be highly effective in hidden caries assessment and restoration.

Thromboelastography clot strength profiles and effect of systemic anticoagulation in COVID-19 acute respiratory distress syndrome: a prospective, observational study.

OBJECTIVE: Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection may yield a hypercoagulable state with fibrinolysis impairment. We conducted a single-center observational study with the aim of analyzing the coagulation patterns of intensive care unit (ICU) COVID-19 patients with both standard laboratory and viscoelastic tests. The presence of coagulopathy at the onset of the infection and after seven days of systemic anticoagulant therapy was investigated. PATIENTS AND METHODS: Forty consecutive SARS-CoV-2 patients, admitted to the ICU of a University hospital in Italy between 29th February and 30th March 2020 were enrolled in the study, providing they fulfilled the acute respiratory distress syndrome criteria. They received full-dose anticoagulation, including Enoxaparin 0.5 mg·kg-1 subcutaneously twice a day, unfractionated Heparin 7500 units subcutaneously three times daily, or low-intensity Heparin infusion. Thromboelastographic (TEG) and laboratory parameters were measured at admission and after seven days. RESULTS: At baseline, patients showed elevated fibrinogen activity [rTEG-Ang 80.5° (78.7 to 81.5); TEG-ACT 78.5 sec (69.2 to 87.9)] and an increase in the maximum amplitude of clot strength [FF-MA 42.2 mm (30.9 to 49.2)]. No alterations in time of the enzymatic phase of coagulation [CKH-K and CKH-R, 1.1 min (0.85 to 1.3) and 6.6 min (5.2 to 7.5), respectively] were observed. Absent lysis of the clot at 30 minutes (LY30) was observed in all the studied population. Standard coagulation parameters were within the physiological range: [INR 1.09 (1.01 to 1.20), aPTT 34.5 sec (29.7 to 42.2), antithrombin 97.5% (89.5 to 115)]. However, plasma fibrinogen [512.5 mg·dl-1 (303.5 to 605)], and D-dimer levels [1752.5 ng·ml-1 (698.5 to 4434.5)], were persistently increased above the reference range. After seven days of full-dose anticoagulation, average TEG parameters were not different from baseline (rTEG-Ang p = 0.13, TEG-ACT p = 0.58, FF-MA p = 0.24, CK-R p = 0.19, CKH-R p  = 0.35), and a persistent increase in white blood cell count, platelet count and D-dimer was observed (white blood cell count p < 0.01, neutrophil count p = 0.02, lymphocyte count p < 0.01, platelet count p = 0.13 < 0.01, D-dimer levels p= 0.02). CONCLUSIONS: SARS-CoV-2 patients with acute respiratory distress syndrome show elevated fibrinogen activity, high D-dimer levels and maximum amplitude of clot strength. Platelet count, fibrinogen, and standard coagulation tests do not indicate a disseminated intravascular coagulation. At seven days, thromboelastographic abnormalities persist despite full-dose anticoagulation.

Clinical comparison between an opaque and a clear pit and fissures sealants: a 12-month split-mouth, randomized controlled study.

TRIAL DESIGN: We design a clinical splith-mouth, randomized controlled study, in which the retention of an opaque and clear pit and fissures sealants were evaluated and their effectiveness compared at 6 and 12 months of follow up. A secondary aim was to evaluate the possibility of using a fluorescence based intra-oral camera through the clear sealant to monitor enamel demineralization. METHODS: Consecutive young adolescents with at least two molars with code 0, 1, 2 caries evidenced following the International Caries Detection and Assessment System (ICDAS II) were enrolled. A split-mouth randomized allocation was carried out. One skilled operator applied the sealant under 3.5 X magnification. A second operator evaluated clinical retention and performed the intra-oral camera assessments at 6 and 12 months follow up. RESULTS: A total of 42 patients, (20 males and 22 females, mean age 14.25) with 176 dental lesions were enrolled. Nine patients dropped out accounting for 26 teeth lost during follow up. Overall, a total of 150 sealed teeth were evaluated in the study. In 77 cases the clear sealant was used, while in 73 the opaque sealant was utilized. The opaque sealant rated 100% complete retention at 6 months, and 97.3% at 12 months, while the clear selant 91.8% and 85.9% respectively. Demineralization under clear selant was registered when sealant partial detachment occurred. CONCLUSIONS: The overall retention rate of an opaque sealant was higher than that of a clear sealant after 12 months of follow-up. This difference may partly be due to difficulty in clinical detection of clear sealants during follow-up. Fluorescence based intra-oral camera seems useful to monitor enamel demineralization in clear sealant.

[Knowledge, attitude and behavior towards oral health: gender differences between parents].

OBJECTIVES: The aim of this study is to compare the results of a survey carried out on a sample of mothers and fathers about the knowledge and personal attitudes towards their own oral health and in terms of attention to that of their children. Mutual analogy and cognitive and behavioral differences between parents have been evaluated; in particular as the early assumption of a healthy lifestyle can influence the proper development of their children. MATERIALS AND METHODS: This survey was conducted using a paper questionnaire distributed to a population of parents, men and women, in several private dental practices in Rome. The study lasted about three months. RESULTS: The results obtained from this study show that values obtained by mothers and fathers are essentially equivalent, there are no statistically significant differences (p> 0.05). CONCLUSIONS: This study has shown that there are no significant thinking and behavioral differences between parents regarding their oral hygiene and that of their children. Both parents have been shown to recognize the importance of continuous monitoring and to be aware of techniques and oral hygiene aids suitable for adults and children, although this knowledge is not always applied in daily lifestyles and oral hygiene.

Obstructive site localization in patients with Obstructive Sleep Apnea Syndrome: a comparison between otolaryngologic data and cephalometric values.

PURPOSE: Obstructive Sleep Apnea Syndrome (OSAS) is a respiratory disorder characterized by repeated obstructive episodes affecting upper airways.This study aims at examining the anatomical craniofacial and pharyngeal characteristics of the patient as to identify the obstructive site which triggers the pathologic process.Correlations between otolaryngologic data observed in the patient and the cephalometric ones for the identification of the obstructive site were also highlighted. MATERIALS AND METHODS: We worked on a sample of 16 patients, 12 males and 4 females, attended to at the Otolaryngology Operative Unit of Bari University Hospital.The patients underwent an otolaryngologic (ORL) diagnostic procedure which provided for ApneaGraph (AG) recording, and a dental diagnostic procedure with cephalometric assessment. RESULTS: The statistical analysis highlighted a strict correlation between the otolaryngologic value of AHI and the cephalometric values of the ANB angle, with the distance between the hyoid bone and the mandibular plane and with the distance between the hyoid bone and the plane passing between C3 and Me. CONCLUSIONS: We observed a concurrence between the ORL diagnosis of the obstruction level assessed with AG and the cephalometric values regarding respiratory tracts (IPAS and SAS). More precisely, we observed the correlation between the otolaryngologic value of AHI with cephalometric values of the ANB angle, with the distance between hyoid bone and mandibular plan, and with the distance between the hyoid bone and the plane passing between C3 and Me. Furthermore, the identification of the caudal position of the hyoid bone can be considered an alarm bell in the diagnosis of severe OSAS.

Oral health sentinel-based surveillance: a pilot study on dentinal hypersensitivity pain.

Aim of the study is to assess the development of a structured sentinel system for oral health data collection at national level. Furthermore, this pilot study aims to investigate the prevalence data on dentinal sensitivity pain collected through a nationwide network of epidemiological sentinels (dental hygienists). Each sentinel was given a specific number of examinees and periodicity of data collection. Overall, 116 adults were recruited from 19 Regions, 42,24% male and 57,76% female, with a mean age of 26. DH result was consistent with literature data, being 45%. All sentinel completed the standard forms and assured a good compliance. The overall good customer satisfaction assures adhesion of the sentinels to the procedure, and the regular data collection. The pilot study proved the effectiveness of a structured nationwide network of epidemiological sentinels (dental hygienists) for oral health data collection at national level. This methodology can be an essential starting point for periodic comparative studies.

Correlation between parodontal indexes and orthodontic retainers: prospective study in a group of 16 patients.

PURPOSE: Fixed retainers are used to stabilize dental elements after orthodontic treatment. Being it a permanent treatment, it is necessary to instruct patients about a constant and continuous monitoring of their periodontal conditions and a correct oral hygiene. The aim of this study was to highlight the possible adverse effects of bonded retainers on parameters correlated to the health conditions of periodontal tissues. MATERIALS AND METHODS: We selected 16 patients, under treatment in the Orthodontics Department of University of Bari Dental School, who had undergone a lingual retainer insertion at the end of the orthodontic treatment. The patients were then divided into two groups (Control Group and Study Group) and monitored for 3 and 36 months, respectively. The following indexes were taken into consideration: gingival index (GI), plaque index (PI) and the presence of calculus (Calculus Index, CI), the probing depth and the presence of gingival recession on the six inferior frontal dental elements. RESULTS: After the observation was carried out, any of the patients showed periodontal sockets and gingival recession. In the Study Group, only 1 patient had a PI score=3, the 7 left had scores between 0.66 and 2.83. In the Control Group, one patient had score=0, the other ones showed values between 0.5 and 1.66. The mean GI in the Study Group peaked at a score of 2.83, the minimum was 0.66; whereas in the Control Group the maximum value was 2 and the minimum 0.66. The CI in the Group Study was between 1 and 2. In the Control Group it was absent in only 1 patient, whereas in the remaining 7, it had a value between 0.3 and 1. The clinical data were studied by means of the Wilcoxon test. We found a statistically significant difference for what concerns the Plaque Indexes (PI) (P>0.05) and Calculus Indexes (CI) (P>0.1) in both groups, with higher scores in the Study Group, having retainers for 36 months. Any statistically significant difference was calculated for the GI. CONCLUSIONS: We can therefore conclude that patients with lingual retainers need periodontal hygiene and treatment as to prevent, in the course of time, periodontal damages non-detectable in short-term.

Oral probiotics in the management of gingivitis in diabetic patients: a double blinded randomized controlled study.

Diabetic patients are more prone to develop infections such as periodontal diseases. Bacteriotherapy with the concept of using good bacterial strains to replace the pathogenic ones emerged as a fascinating field due to the increasing incidence of antibiotic resistance. The aim of this study was to evaluate if a particular combination of probiotics (Lactobacillus Reuteri DSM 17938 and Lactobaciullus Reuteri ATCC PTA 5289) is useful in treating gingivitis in diabetic patients. Eighty adult patients with diagnosis of controlled diabetes type II and gingivitis were enrolled for this study and randomized in two groups. Only oral hygiene instructions were given. Bacteriotherapy (Lactobacillus Reuteri) was administered to test group. Outcome measures were presence of Plaque (P.I.) and Bleeding on Probing (B.O.P.). Data were collected at baseline and after 30 days. At 30 days, both groups showed a statistically significant clinical indexes reduction from baseline. More reduction was present in the test group for P.I. (14%±6) and for B.O.P. (18%±4) and was statistically significant (p less than 0.05). Within the limitations of this study, bacteriotherapy can be considered effective in reducing plaque and BOP in patients with controlled diabetes type II and gingivitis.

Photobiomodulation with polarized light in the treatment of cutaneous and mucosal ulcerative lesions.

In recent decades, regenerative medicine has achieved an important evolution at both a conceptual level and scientific production, which explains the current and future possibilities of therapy and daily clinical practice. The main aim of regenerative medicine is the complex system of repair/regeneration. The current literature on the subject demonstrates the advantage of visible light therapy for skin injuries and diseases with the photobiomodulation in which light at low energy levels modulates intra- and extra-cellular photoreceptors by molecular and cellular processes that can stimulate both anti-inflammatory mechanisms and cell proliferative response. The irradiation effects are activated soon after exposure. The anti-inflammatory action on some classes of cytokines and cells (e.g. mast cells and macrophages) is completed with the stimulation of the nitric oxide production, which has an anti-inflammatory and vasodilation action, and gives analgesic relief. Our attention focused on photobiomodulator medical device emitting polarized light. 30 patients (19 women and 11 men) were enrolled in the present study. They were treated for chronic lesions using Bioptron® Light Therapy System device. Patients were initially subjected to Bioptron® light for 20 min after cleansing of the lesion. The operating protocol provides 24 sessions: twice per week for 12 weeks. Twenty patients have been studied for symptoms, histological samples and ulcer characteristics. After 2 months, a reduction of 50% of the lesions was recorded in 18 patients (60%), while in the remaining patients a slower healing was observed. The total wound healing was achieved after 3 months in 13 patients (43%). The examined parameters of the symptom were exudation, pain and signs of infection. Results at 1 and 3 months were, Exudation: at 1 month reduction and positive modulation was observed in 16 patients (53%) and in 25 patients at 3 months; Pain: (evaluated with Vas scale), decreased in 21 patients at 1 month (70%) and in 100% of cases at 3 months; Infections: regressed or disappeared in 100% of cases after the first month. Today, it is no longer time for monotherapy applications, especially in regenerative medicine and the adoption of biophysical therapies can play a positive anti-inflammatory and regenerative role enhancing the function of non-invasive therapies.

Early mandibular canine-lateral incisor transposition: case report.

PURPOSE: The main aim of the present study is to present a case of mandibular transposition between lateral incisor and canine in a paediatric patient. MATERIALS AND METHODS: A fixed multibracket orthodontic treatment was performed by means of a modified welded arch as to correct the transposition and obtaining a class I functional and symmetrical occlusion, also thanks to the early diagnosis of the eruption anomaly. RESULTS: Our case report shows that a satisfactory treatment of mandibular transpositions is obtained when detected at an early stage of the tooth development. CONCLUSIONS: The main treatment options to be taken into consideration in case of a mandibular transposition are two: correcting the transposition or aligning it leaving the dental elements in their transposed order; in both cases, the follow-ups show a stable condition, maintained without relapses. Several factors, such as age of the patient, occlusion, aesthetics, patient's collaboration, periodontal support and duration of treatment have to be considered as to prevent potential damage to dental elements and support appliances. The choice between the two treatment approaches for mandibular lateral incisor/canine transpositions mainly depends on the time the anomaly is detected.

Effects of the application of high-pressure oxygen on the treatment of periodontal disease in diabetic patients.

PURPOSE: In this study we wanted to observe the improvement in the healing of periodontal tissues in a group of diabetic patients treated with traditional methods compared to another group treated with the addition of oxygen.The potential of oxygen has long been known in the field of plastic surgery, where it is used to treat burns and skin lesions. MATERIALS AND METHODS: This study consists in a split mouth study which involved 30 patients. We carefully treated them with periodontal therapy using manual and mechanical instrumentation. Then, we applied oxygen in half mouth according to randomization list. Finally we checked up patients after some weeks. RESULTS: Our results highlight that all areas treated with oxygen application healed more rapidly and better than no treated areas. CONCLUSIONS: All in all, we have demonstrated that oxygen can improve the outcome of non-surgical periodontal treatment in diabetic subjects.

Cytokine genotype distribution in patients with periodontal disease and rheumatoid arthritis or diabetes mellitus.

The association between oral and systemic health has highlighted the importance of periodontal health and treatment, with the consequence that dental assessment and attention to oral hygiene have assumed an increasingly important part in the clinical management of patients with diabetes mellitus and rheumatoid arthritis. The aim of this work was to assess genotype frequencies in polymorphisms of genes of IL-1α-889 and IL-1ß-511 in a case-controlled study population of patients affected by periodontal disease and rheumatoid arthritis or diabetes mellitus.

Why should patients with systemic disease and tobacco smokers go to the dentist?

Periodontal diseases (PD) affect about half of the adult population all over the world. PD is caused by bacterial infection which induces an inflammatory response with progressive destruction of the periodontal tissues and finally the loss of teeth. Tobacco smoking (TS), alcohol consumption, and systemic diseases (SDs), such as cardiovascular diseases, diabetes mellitus, respiratory diseases, osteoporosis, malnutrition and stress, are considered additional risk factors. This short review examines the potential causal association between PD, TS and SDs. There is strong evidence that PD is associated with an increased risk of SDs. In addition, many patients with SDs are also affected by PD, which can be mild or severe, and tobacco smokers manifest a greater risk of developing PD. The aim of this manuscript is to investigate the effects of periodontal therapy on the management of SDs and influence of TS on PD. This manuscript includes many randomized controlled trials and reviews to test the effects of different periodontal therapies for patients with SDs. A definite conclusion on the relationship between PD and SDs is lacking, however, there is sufficient evidence to justify periodontal treatment to prevent SDs; in fact, PD is prevalent in the middle-aged population and can have a significant impact on systemic health.

The ecological catastrophe of oral diseases: a possible link between periodontitis and protozoa.

Periodontal disease (PD) is one of the prevalent diseases in the adult population. The ethiology of PD has never been completely understood, however, loss of balance between the host immune system and the microbial virulence of PD pathogens may be considered the trigger of PD. In fact, the immune system, activated by microbiological agents, attacks the host and not the biofilm bacteria, causing the destruction of periodontal tissue, alveolar bone and loss of teeth. Parasites may play an important role in the pathology of PD. The first studied and the most common parasite in the oral cavity is Entamoeba gingivalis. A possible link between E. gingivalis and PD has never been demonstrated completely, however E. gingivalis is infrequently found in people without PD. In addition, there is evidence that E. gingivalis could favour the onset and progression of PD. In conclusion, we can assert that E. gingivalis and PD may be correlated. This relationship can open new therapeutical approaches for treating PD, particularly in cases refractory to therapy.