Longitudinal assessment of peri-implant diseases in patients with and without history of periodontitis: A 20-year follow-up study.

PURPOSE: To longitudinally assess the prevalence of peri-implant health, peri-implant mucositis and peri-implantitis in a cohort of patients with and without history of periodontitis over a 20-year period. MATERIALS AND METHODS: Eighty-four patients who attended a specialist private periodontal practice were evaluated prospectively 10 and 20 years after prosthesis delivery. Following successful completion of periodontal/implant therapy, patients (172 implants) were enrolled on an individualised supportive periodontal care programme. Clinical and radiographic parameters were collected to assess the prevalence of peri-implant health and diseases. Prevalence of peri-implantitis and peri-implant mucositis was calculated based on the case definition set out in 2018. A multilevel logistic regression analysis was conducted to assess potential risk or protective factors. RESULTS: The analysis was performed on 22 periodontally healthy and 62 periodontally compromised patients rehabilitated with 39 and 130 implants, respectively. The 10-year prevalence of peri-implant health, peri-implant mucositis and peri-implantitis was 21.4%, 67.9% and 10.6%, respectively, whereas the 20-year prevalence was 29.8%, 47.6% and 33.3%, respectively. Non-compliant periodontally compromised patients showed a statistically significantly increased risk at 20 years of both peri-implant mucositis (odds ratio 11.1; 95% confidence interval 1.8-68.6) and peri-implantitis (bone loss and probing depth) (odds ratio 14.3; 95% confidence interval 1.8-32.9). High full-mouth plaque and bleeding scores were associated with higher odds of both peri-implant mucositis and peri-implantitis. CONCLUSIONS: Peri-implant diseases were prevalent in patients rehabilitated with dental implants and followed up for a period of 20 years. History of periodontal disease and a lack of compliance with a tailored supportive periodontal care programme were identified as risk factors for peri-implant diseases.

Population pharmacokinetics and exposure-response assessment of veliparib co-administered with temozolomide in patients with myeloid leukemias.

PURPOSE: Veliparib is an oral inhibitor of poly(ADP-ribose) polymerase enzyme. Combination of veliparib and temozolomide was well-tolerated and demonstrated clinical activity in older patients with relapsed or refractory acute myeloid leukemia (AML) or AML arising from pre-existing myeloid malignancies. We aimed to perform quantitative assessments of pharmacokinetics, efficacy, and safety of veliparib in this patient population to inform future trial design. METHODS: Population pharmacokinetic analysis was performed using Phoenix® NLME with pharmacokinetic data obtained from 37 subjects after oral administration of veliparib in a Phase I study with and without temozolomide. Effect of covariates (age, sex, BMI, creatinine clearance (CLCR), and co-administration of temozolomide) on the pharmacokinetics of veliparib were evaluated, as well as impact of veliparib exposure on mucositis (dose-limiting toxicity), objective response rate (ORR), and overall survival. RESULTS: A two-compartment model with first-order elimination and a first-order absorption with lag-time adequately described veliparib pharmacokinetics. CLCR and body weight were clinically significant covariates for veliparib disposition. The proportion of subjects with all grade mucositis increased with veliparib exposure (AUC). However, no trend in ORR and overall survival was observed with increasing exposure. CONCLUSIONS: Veliparib with temozolomide presents a promising combination for older patients with myeloid leukemias. An exposure-safety relationship was established for this combination. Further clinical investigations aimed at elucidating the veliparib exposure-efficacy/safety relationship and optimizing dosing recommendations for maximizing benefit-risk in patients with advanced myeloid malignancies should study veliparib doses ranging up to 120 mg in combination with temozolomide.

Clinical and radiographic assessment of implant-supported rehabilitation of partial and complete edentulism: a 2 to 8 years clinical follow-up.

OBJECTIVE: The aim of this study was to find out the rates of survival and success of implant rehabilitation, and the influence of some risk indicators on the medium- and long-term prognosis. PATIENTS AND METHODS: Of the 102 patients eligible for this study rehabilitated with dental implants during the years 2009-2015, 75 patients with 156 implants of different implant systems placed and loaded by the same team were recalled. For each subject, pocket-probing depth, bleeding on probing, plaque buildup, mobility of the fixtures, and the presence/absence of prosthetic complications were recorded. Radiographic evaluation was based on the analysis of bone levels around the fixtures, as shown by intraoral radiographs. RESULTS: The average follow-up was 4.4 years, ranging from 1.5 to 7.8 years. One hundred and fifty-four of the implants survived, while two implants failed; 98.8% of the prostheses survived, while 75.9% were successful. Success was achieved in 90.4% of implants and in 80% of patients. The sample showed average radiographic bone resorption of 1.09 mm. The average pocket probing depth was 2.79 mm. Bleeding on probing was found in 18% of all sites, and 59.6% of implants showed bleeding on probing in at least one site. Mucositis was found in 90% of patients, and peri-implantitis was found in 16% of patients. CONCLUSIONS: The rates of success and survival showed the reliability of implant therapy. Plaque accumulation, smoking and upper jaw location, seem to increase the risk of failure of implant-supported rehabilitation.

US oncology-wide incidence, duration, costs and deaths from chemoradiation mucositis and antimucositis therapy benefits.

Approximate oncology-wide incidence, duration, costs and deaths associated with mucositis and identify health economic benefits of antimucositis therapies. Review the literature relevant to the clinical experience of mucositis by pathophysiology, incidence, duration, costs and deaths. Use US insurance actuarial and epidemiology on cancer to generalize an oncology-wide impact of toxic mucositis. Toxic mucositis causes oropharyngoesophageal ulcerations, chemo-induced nausea, vomiting and diarrhea. Acutely, it lasts 102 days/six cycles of chemotherapy, 60 days in human stem-cell transplantation patients and 70-84 days in head and neck cancer patients at annual costs of US$13.23 billion/522,166 treated patients (US$20,892/erosive-type mucositis patient, US$25,337/physiologic mucositis patient) and 46,699 deaths. Using antimucositis therapies prior to 2013 provided fractional benefits at high costs. By completely preventing and rapidly reversing mucositis, high-potency polymerized cross-linked sucralfate promises superior health economic benefits.

Assessment of early toxicity and response in patients treated with proton and carbon ion therapy at the Heidelberg ion therapy center using the raster scanning technique.

UNLABELLED: PUROPOSE: To asses early toxicity and response in 118 patients treated with scanned ion beams to validate the safety of intensity-controlled raster scanning at the Heidelberg Ion Therapy Center. PATIENTS AND METHODS: Between November 2009 and June 2010, we treated 118 patients with proton and carbon ion radiotherapy (RT) using active beam delivery. The main indications included skull base chordomas and chondrosarcomas, salivary gland tumors, and gliomas. We evaluated early toxicity within 6 weeks after RT and the initial clinical and radiologic response for quality assurance in our new facility. RESULTS: In all 118 patients, few side effects were observed, in particular, no high numbers of severe acute toxicity were found. In general, the patients treated with particle therapy alone showed only a few single side effects, mainly Radiation Therapy Oncology Group/Common Terminology Criteria grade 1. The most frequent side effects and cumulative incidence of single side effects were observed in the head-and-neck patients treated with particle therapy as a boost and photon intensity-modulated RT. The toxicities included common radiation-attributed reactions known from photon RT, including mucositis, dysphagia, and skin erythema. The most predominant imaging responses were observed in patients with high-grade gliomas and those with salivary gland tumors. For skull base tumors, imaging showed a stable tumor outline in most patients. Thirteen patients showed improvement of pre-existing clinical symptoms. CONCLUSIONS: Side effects related to particle treatment were rare, and the overall tolerability of the treatment was shown. The initial response was promising. The data have confirmed the safe delivery of carbon ions and protons at the newly opened Heidelberg facility.

Ensuring accurate oral mucositis assessment in the European Group for Blood and Marrow Transplantation Prospective Oral Mucositis Audit.

Oral mucositis (OM) has substantial negative clinical, quality-of-life, and economic consequences for patients with haematologic malignancies who require myeloablative chemotherapy or radiotherapy. Uniform training in OM assessment is infrequent in clinical practice, so the true incidence and duration of OM are unknown. Nurses and physicians from the European Group for Blood and Marrow Transplantation recently undertook an audit of 214 patients (197 evaluable patients) treated at 25 centres, the Prospective Oral Mucositis Audit (POMA), to determine the incidence, severity, and duration of OM. To standardise the assessment of OM severity, the World Health Organization (WHO) Oral Toxicity Scale was used across centres. This article focuses on the quality control analyses that were conducted to ensure that OM was accurately assessed across all 25 centres. Twenty-two trainers, who received comprehensive training about POMA study design, pathobiology of OM, and endpoint assessment, educated staff at the 25 transplantation centres about OM assessment. The trained staff collected data by completing daily worksheets for each patient. Three quality control analyses, of 82, 1949, and 4111 worksheets respectively, showed a nurse assessment accuracy rate of 74%, 90%, and 90%. The most common errors were in assigning WHO grade 0 or 1. This analysis shows that training of nursing staff had a positive effect on assessment of OM severity, which should ultimately lead to improvement in the quality of supportive care.

Alimentary mucositis: putting the guidelines into practice.

BACKGROUND: The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology completed an evidence-based review of the literature for the management of alimentary mucositis. DISCUSSION: The present manuscript puts these guidelines into clinical practice by presenting two cases of alimentary mucositis from cancer therapy. These cases illustrate the impact of oral and gastrointestinal mucositis on patient care.