Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.

BACKGROUND: Promoting well-being and preventing poor mental health in young people is a major global priority. Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this. However, few large-scale controlled trials have examined the efficacy of mobile apps in promoting mental health in young people; none have tailored the app to individual profiles. METHOD/DESIGN: The Emotional Competence for Well-Being in Young Adults cohort multiple randomised controlled trial (cmRCT) involves a longitudinal prospective cohort to examine well-being, mental health and EC in 16-22 year olds across 12 months. Within the cohort, eligible participants are entered to either the PREVENT trial (if selected EC scores at baseline within worst-performing quartile) or to the PROMOTE trial (if selected EC scores not within worst-performing quartile). In both trials, participants are randomised (i) to continue with usual practice, repeated assessments and a self-monitoring app; (ii) to additionally receive generic cognitive-behavioural therapy self-help in app; (iii) to additionally receive personalised EC self-help in app. In total, 2142 participants aged 16 to 22 years, with no current or past history of major depression, bipolar disorder or psychosis will be recruited across UK, Germany, Spain, and Belgium. Assessments take place at baseline (pre-randomisation), 1, 3 and 12 months post-randomisation. Primary endpoint and outcome for PREVENT is level of depression symptoms on the Patient Health Questionnaire-9 at 3 months; primary endpoint and outcome for PROMOTE is emotional well-being assessed on the Warwick-Edinburgh Mental Wellbeing Scale at 3 months. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and cost-effectiveness are secondary outcomes. Compliance, adverse events and potentially mediating variables will be carefully monitored. CONCLUSIONS: The trial aims to provide a better understanding of the causal role of learning EC skills using interventions delivered via mobile phone apps with respect to promoting well-being and preventing poor mental health in young people. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective Mobile-health public health strategies for preventing poor mental health and promoting well-being. TRIAL REGISTRATION: ClinicalTrials.gov ( www.clinicaltrials.org ). Number of identification: NCT04148508 November 2019.

Osseointegration of SLActive implants in diabetic pigs.

OBJECTIVES: Diabetes mellitus is currently classified as a relative contraindication for implant treatment because of microangiopathies with the consequence of impaired bone regeneration and higher rates of implant failure. The study aim was to investigate peri-implant bone formation in a diabetic animal model in comparison to healthy animals and to evaluate the differences between conventional (SLA(®) ) and modified (SLActive(®) ) titanium implant surfaces on osseointegration. MATERIAL AND METHODS: Each six implants were placed in the calvaria of 11 diabetic and 4 healthy domestic pigs. At 30 and 90 days after implant placement, the bone-to-implant contact (BIC) and bone density (BD) were appraised. Additionally, the expression of the bone-matrix proteins collagen type I and osteocalcin was evaluated at both points in time by using immunohistochemical staining methods. RESULTS: Overall, BIC was reduced in the diabetic group at 30 and 90 days. After 90 days, the SLActive(®) implants showed significantly higher BICs compared with the SLA(®) implants in diabetic animals. Peri-implant BD was higher in the SLActive(®) group at 30 and 90 days in healthy and diabetic animals. Collagen type I protein expression was higher using SLA(®) implants in diabetic pigs at 30 days. Values for osteocalcin expression were not consistent. CONCLUSIONS: The results indicate the negative effect of untreated diabetes mellitus on early osseointegration of dental implants. The modified SLA(®) surface (SLActive(®) ) elicited an accelerated osseointegration of dental implants, suggesting that a better prognosis for implant treatment of diabetic patients is possible.

Biofunctionalization of the implant surface with different concentrations of a synthetic peptide (P-15).

OBJECTIVE: This study aimed at identifying the ideal concentration of a biofunctional surface coating of dental implants with a synthetic peptide (P-15). In a previous study, P-15 was shown to enhance osseointegration parameters. MATERIAL AND METHODS: Implants (modified ANKYLOS(®) A8; FRIADENT Plus(®) surface) with five different concentrations (0-400 µg/ml) of a P-15 coating as well as uncoated controls were inserted in the frontal bone of 45 adult domestic pigs. The histomorphometric and microradiographic findings for the coated implants were compared to those for the uncoated ones after 7, 14, and 30 days. RESULTS: No significant differences were observed comparing the peri-implant bone density between the coated and uncoated implants The bone-to-implant contact, as the primary histological parameter for osseointegration, showed high rates for all surfaces investigated (between 73.3 ± 17.9% for the control and 81.9 ± 15.2% for P15 20 µg/ml after 30 days). CONCLUSIONS: No significant benefit on osseointegration of a biofunctional P-15 coating of dental implants could be displayed in the present study.

i.lect, a pre-graduate education model of implantology.

OBJECTIVE: In 2008, a consensus meeting of the Association for Dental Education in Europe stated that dental implant treatment represents a popular treatment alternative and, therefore, it should be an integral part of dental student pre-graduate education. In 2009, the Friedrich-Alexander University, Erlangen-Nuremberg implemented a voluntary, structured, education program for pre-graduate dental students, called 'i.lect'. The present study evaluated the effectiveness of the i.lect program. METHODS: Concurrent to the dental curriculum, the i.lect program provides 200 hours in 3 years of theoretical and practical education on all aspects of modern dental implantology. We recruited dental students in the i.lect program and additionally students from 15 other universities that voluntarily participated in a single, 3-day implantology camp (R = 58). To demonstrate their knowledge on dental implant issues, both student groups completed a written examination that covered 'Basic information and materials of implantology', 'Implant planning' and 'Soft tissue management'. RESULTS: The students in the i.lect program achieved higher scores than students from the implantology camp on questions concerning 'basic implantology' and 'implant planning'. CONCLUSION: The results indicated that the structured i.lect undergraduate curriculum enhanced individual knowledge in the specific field of implantology. This program could have pilot character for use in other universities.

Biofunctionalization of titanium implants with a biomimetic active peptide (P-15) promotes early osseointegration.

OBJECTIVES: The early stages of peri-implant bone formation play an essential role in the osseointegration and long-term success of dental implants. By incorporating bioactive coatings, this biofunctionalization of implant surfaces may enhance the attachment of the implant to the surrounding bone and stimulate bone regeneration. MATERIAL AND METHODS: To demonstrate faster osseointegration, the surfaces of dental implants were grit-blasted and acid-etched. They were then coated with hydroxyapatite (HA) and experimental implants were further coated with a biomimetic active peptide (P-15) in one of two concentrations. These biofunctionalized samples and controls with no peptide were placed in the forehead region of 12 adult pigs. Six animals were evaluated for a period of 14 or 30 days. RESULTS: Histomorphometric analysis demonstrated that the implants with the high concentration of P-15 had significantly higher percentage of bone-to-implant contact (BIC) at 14 (P=0.018) and 30 (P=0.015) days compared with the other groups. Both concentrations of P-15 showed increased peri-implant bone density compared to the control group at 30 days. CONCLUSION: Biofunctionalization of the implant surface with a biomimetic active peptide leads to significantly increased BIC rates at 14 and 30 days and higher peri-implant bone density at 30 days.

Experimental peri-implant mucositis around titanium and zirconia implants in comparison to a natural tooth: part 2-clinical and microbiological parameters.

The aim of this study was to assess the clinical and microbiological parameters around dental zirconia and titanium implants compared with natural teeth during experimental plaque accumulation. Clinical parameters were evaluated (gingival index, plaque index, bleeding on probing, and probing pocket depth). Microbiological samples were analyzed for total bacterial cell counts, as well as Tannerella forsythia and Prevotella intermedia counts. A statistically significant difference over time was observed in the groups in terms of the gingival index (P<0.001), plaque index (P<0.001), and bleeding on probing (P=0.039). The lowest mean total number of bacterial cells was measured around the teeth, followed by the zirconia implants; the highest values were found around the titanium implants. T. forsythia and P. intermedia values showed significant changes over time and sessions around the titanium implants. Compared to the soft tissues around zirconia implants and the teeth, those around titanium implants developed a stronger inflammatory response to experimental plaque accumulation in terms of the total number of bacterial cells and T. forsythia and P. intermedia values.

[Enophthalmos correction in complex orbital floor reconstruction : computer-assisted, intraoperative, non-contact, optical 3D support]. / Enophthalmuskorrektur bei komplexer Orbitarekonstruktion : Computerassistierte, intraoperative, berührungsfreie, optische 3D-Unterstützung.

In the case of displacement of the globe such as enophthalmos induced by trauma, the patient is affected on both counts: function and aesthetics. To prevent double vision or conspicuous asymmetry, exact correction of the globe position is required. The aim of this case report is to demonstrate an intraoperative computer-assisted, non-contact, optical 3D procedure for identification of the globe position to aid in placing the eyeball in the position required in complex reconstruction of the orbital floor. A 33-year-old man presented with a sunken eye on the right side in the horizontal and vertical plane 6 months after having undergone surgery elsewhere for a zygomatico-orbital fracture, also including the orbital floor. The patient was affected by double vision and a noticeable defective globe position. In planning the correction of the globe position, a three-dimensional image of the face with opened eyes was made with the optical sensor. Automatic comparison of symmetry revealed enophthalmos of 4 mm on relative en- and exophthalmometry. The decision was made to lift the orbital floor with a split calvarial bone graft. During surgery the position of the globe was also controlled by the three-dimensional optical technique. At the end of surgery there was exophthalmos of 1 mm. Six weeks after surgery the patient was not affected by any double vision. After 3 and 24 months enophthalmos was 1 mm. This case demonstrates how the non-ionizing, non-contact, optical 3D technique can help in planning, intraoperative transformation, and clinical monitoring to identify the correct position of the corneal vertex in complex orbital floor reconstruction.

[Computer-assisted orbital floor reconstruction. Use of a CAD/CAM implant with intraoperative contact-free 3D endo- and exophthalmometry]. / Computerassistierte Enophthalmuskorrektur. Nutzung eines CAD/CAM-Implantats unter intraoperativer, berührungsfreier 3D-en- und exophthalmometrischer Kontrolle.

Pronounced enophthalmos can restrict patients both functionally and aesthetically. Typical symptoms are double vision on both eyes and obvious asymmetry, both of which were present in the 67-year-old male patient presented in this paper. The resulting data of computed tomography was used to fabricate a patient specific ceramic implant for reconstruction of the left orbital floor with an enophthalmos of 4mm. During the surgery the implant fitted anatomically correct, but exophthalmos occurred. The implant needed to be regraded and recontoured in the dorsal fraction, so that overcorrection could be reduced. With the assistance of optical 3D en- and exophthalmometry during surgery, the position of the cornea vertex was reproducible measured. At the end of surgery, exophthalmos was 1.5 mm. After 12 months, enophthalmos of only 1mm exists. This case displays the combination of a patient specific fabricated implant for reconstruction of the orbital floor with optical 3D-en-and exophthalmometry to correct enophthalmos with a high degree of accuracy. Therefore these two techniques in combination should be used when complex corrections of enophthalmos are needed.

Evaluation of peri-implant bone levels and soft tissue dimensions around zirconia implants-a three-year follow-up study.

The aim of this study was to measure bone levels around zirconia implants during follow-up of up to 3 years. Additionally, the effect of clinical contact point positions on the papilla deficit was evaluated. Eighty-one patients with 105 zirconia implants were examined at the 3-year follow-up. Bone levels were measured on the date of implant placement and at 3 months, 1year, and 3 years thereafter. Distances between the first bone-implant contact and the contact point of the crowns and between the bone level at the adjacent tooth and the contact point of the crowns were assessed. The effect of the clinical contact point position on the papilla deficit was also assessed. Significant reductions in the distances between the bone-implant contact and the implant shoulder, as well as the contact point of the crowns, and between the bone level at the adjacent tooth and the contact point of the crowns, were found. A significant association was found between the papilla deficit and the height of the contact point. Implant survival was 100% and implant success was 95.4%. While zirconia implants presented little bone loss up to 1year, significant bone apposition was observed up to 3years. Low contact points correlated with full papillae, whereas high contact points were associated with a papilla deficit.

The effect on bone regeneration of a liposomal vector to deliver BMP-2 gene to bone grafts in peri-implant bone defects.

Successful bone-implant osseointegration in large peri-implant bone defects is often difficult, even through autologous bone grafting. Recently, cell-mediated regional gene therapy was introduced to deliver potent morphogens or growth factors in regenerative medicine. We applied liposomal vectors carrying bone morphogenetic protein (BMP)-2 cDNA directly into freshly created peri-implant bone defects on pig calvariae, with or without autologous bone graft. The BMP-2 gene was efficiently introduced into immigrating cells and trabecular cells lining the marginal bone surrounding the bony defect. After 1 week, abundant BMP-2 protein was detected throughout the peri-implant bone defect by immunohistochemistry. At 4 weeks, BMP-producing cells were still present in the defect and peri-implant area, which significantly enhanced new bone formation, compared with the control groups. Interestingly within a week of BMP-2 gene delivery with bone grafts, most osteoblastic cells lining the grafted bone chips also produced BMP-2. Particulated bone was immediately reorganized into newly formed trabecular bone. Grafted bone without BMP-2 gene delivery was still scattered and new bone matrix formation was not detected until 4 weeks after bone grafting. In conclusion, direct application of the BMP-2 gene using a liposomal vector enhanced bone regeneration in a bony defect and gene delivery combined with bone graft could induce a rapid osseointegration of the bone-implant interface at earlier stage.

Evaluation of substitutes for bone: comparison of microradiographic and histological assessments.

We created defects of standard size in the frontal bones of adult pigs and filled them with four different materials. On six occasions (at 1, 2, 4, 8, 12, and 26 weeks), samples were harvested, and evaluated by computing microradiographic images. We examined the specimens histologically as controls. After insertion of anorganic materials, microradiographic evaluation was easy and precise, and there were no significant differences between them and the histological controls (p=0.2). A quantitative evaluation of chemically sterilised bone by computer was not possible for more than 4 weeks.

Search for a reliable model for bisphosphonate-related osteonecrosis of the jaw: establishment of a model in pigs and description of its histomorphometric characteristics.

The pathogenesis of bisphosphonate-related osteonecrosis of the jaw (BRONJ) remains unknown, and the development of a reliable experimental model would help to improve our understanding of it. We used 12 domestic pigs of which 6 made up the experimental group and were treated with zoledronate 4mg intravenously weekly for 5 weeks, while the control group (n=6) were given no drugs. On day 60 the right second maxillary and mandibular third molars were extracted. Thirty days later 3 animals in each group were killed; the rest were killed 90 days later. Histopathological specimens from the extraction sites were analysed for bone density, collagen architecture, density of osteons, and the amount of non-mineralised bone. Bone density, amount of non-mineralised bone, and density of osteons differed significantly between the 2 groups (p<0.001 in each case), but the chromatic pattern dictated by the collagen architecture did not. Our results correspond to the observations that have been made in patients with BRONJ, which means that the histomorphometric conditions seen in patients can be reproduced in this experimental setting.

Expression of bone matrix proteins during de novo bone formation using a bovine collagen and platelet-rich plasma (prp)--an immunohistochemical analysis.

This animal study (domestic pig) examined the bone formation after filling defined defects with autogenous bone or a collagen lyophilisat in combination with Platelet-rich-plasma (PRP) by evaluating bone matrix proteins. Six groups, both materials with and without PRP in two concentrations (+ 1, + 2) were compared to untreated bone by means of immunohistochemistry at 2, 4, 12 and 26 weeks. BMP-2 expression was increased at 2 weeks in the collagen + 1 group and after 4 weeks in the collagen + 1 and + 2 group. Collagen-I expression was increased at 2 weeks in all collagen groups. After 4 weeks raised levels were observed after adding the higher concentrated PRP to bone and the collagen material. Osteocalcin expression was enhanced at 2 weeks in all collagen groups and the autogenous bone + PRP1 group, after 4 weeks in the bone and collagen + 2 groups. At 12 weeks higher values were observed after adding higher concentrated PRP to bone. Osteonectin and especially osteopontin were confirmed to be effective markers of early bone formation in all specimens. The described setting allows to combine established techniques (microradiography, light microscopy) with approaches to explore the underlying biology (immunohistochemistry) on the same specimen.

Establishment of a new pull-out strength testing method to quantify early osseointegration-An experimental pilot study.

OBJECTIVES: The animal study aims to evaluate a new experimental model for measuring sole the influence of the surface characteristics independent from implant macro-design on the level of osseointegration by registering the pull-out strength needed for removal of experimental devices with different surfaces from artificial defects. MATERIAL AND METHODS: Seventy-two test bodies (36 with the FRIADENT(®) plus surface, 36 with the P15/HAp biofunctionalized surface) were inserted in six adult domestic pigs with artificial calvarial defects. The experimental devices were designed to fit in the defects leaving a gap between the test body and the local bone. After 21 days of healing, the animals were sacrificed and the test bodies were pulled out with a standardised reproducible pull-out device measuring the pull-out strength. The pull-out strength for both groups was compared. RESULTS: Twenty-one days after insertion a mean force of 412 ± 142 N for the P15/HAp group and 183 ± 105 N for the FRIADENT(®) plus group was measured for the removal of the specimens from the calvarial bone. The difference between the groups was statistically significant (p < 0.0001). CONCLUSION: The experimental set-up seems to be a suitable method when measuring the impact of implant surfaces on the early stage of osseointegration.

Autoregulatory control of actin synthesis in cultured rat hepatocytes.

ADP-ribosylation of actin by Clostridium botulinum C2 toxin resulted in a depolymerization of filamentous F-actin and an increase of monomeric G-actin in cultured hepatocytes. Simultaneously the de novo synthesis of actin was largely reduced, while the synthesis of albumin and of other proteins was not significantly impaired. The specific decrease of actin mRNA to 30% of the control indicates a down-regulation of actin synthesis at a pretranslational level. On the other hand, treatment with the mycotoxin phalloidin resulted in an increase of F-actin and a decrease of monomeric G-actin. Under this condition the de novo synthesis of actin was specifically enhanced and the level of actin mRNA was increased to 600% of the control. The data suggest an autoregulatory control of the actin synthesis.

Soft tissue findings above submerged titanium implants--a histological and spectroscopic study.

The aim of this study was to check the titanium level within the muco-periosteal flaps covering submerged titanium implants. The investigated material included 38 biopsies taken after 2.4-18 months (mean: 5.9) after implant insertion. Due to the evident time delay between implantation and taking the biopsy any influence of the implantation trauma itself was excluded. The implants came from the following producers: HaTi (Matthys, Switzerland), ITI (Straumann, Switzerland) and Branemark (Nobelbiocare. Sweden). The surface areas of these implants differ in size and structure. A comparison between the titanium impregnation of the investigated biopsies did not demonstrate any remarkable influence of the surface differences. This can be explained by the fact that only the top diameter and not the implant surface as a whole was the contact area with the excised tissue. Titanium in the biopsies was analysed in terms of its effect histologically and regarding the titanium quantity by spectrophotometry. Even the highest titanium contamination was without a negative effect on the muco-periosteal cover flaps. A correlation between time delay between implantation and biopsy or of the titanium amount and tissue reactions was not demonstrable. In summary, the results again highlighted the biological acceptance of titanium.

De novo bone formation using bovine collagen and platelet-rich plasma.

In order to regenerate critical-size bone defects, a variety of bone substitutes is used in addition to autogenous bone. The regenerative capacity of these bone substitutes is usually compared to the efficacy of autogenous bone known as the "golden standard". Different cytokines influence the regeneration process because of their morphogenic or mitogenic properties. Platelet-rich plasma (PRP), a platelet concentrate, is characterised by having a positive effect on wound healing, reducing bone graft resorption and increasing the density of bone transplants. This experiment was commenced with a view to studying the osseous defect regeneration after placing various combinations of "filler materials" in experimentally created defects in the forehead of adult pigs. Regeneration by means of grafted autogenous bone (Group 1) or a bovine collagen based medical device (Group 4) alone and combined with PRP in two concentrations (Groups 2, 3, 5 and 6) was evaluated by means of microradiography and light microscopy after 2, 4 and 12 weeks. The microradiographic and light microscopic findings showed that autogenous bone in combination with PRP (Groups 2 and 3) had a significant accelerating effect on early bone regeneration (2 weeks). This effect was not evident when PRP was added to the bovine collagen (Groups 5 and 6). When using the collagen alone, significantly higher mineralisation values were achieved after 2 and 4 weeks than when using autogenous bone alone. After a 12-week observation period, the existing differences between the healing processes in the various groups were more or less levelled out. In summary, the results of the study indicate that clinically autogenous bone, as expected, is the ideal defect filler. Combining autogenous bone with PRP did not provide significantly better results. The findings in the groups treated with bovine collagen indicate that its local application mimics the effect of autogenous bone and amplifies bone regeneration when comparing with the control defect.

Taste preferences for nutritional supplements: comparison of cancer patients and healthy controls using a wine-tasting scale.

Thirty-nine cancer patients (Ca) and 37 age-and sex-matched healthy controls (Co) evaluated 11 commercially available enteral supplements using a modified wine-tasting scale. The cancer patients were 19 males with lung cancer and 20 females with breast cancer, and their controls consisted of 17 males and 20 females, respectively. Mean evaluation scores for the individual supplements revealed no significant differences (NS) between lung cancer patients and controls. Ensure Plus (strawberry) received the highest score from both groups (Ca 16.0 +/- 3.0 vs Co 17.1 +/- 2.6, N.S.) while Vital received the lowest (Ca 6.3 +/- 4.8 vs Co 4.9 +/- 4.2, NS). Similar results were obtained for breast cancer patients and their controls except that chocolate Sustacal was rated significantly higher by breast cancer patients than by controls (16.6 +/- 2.6 vs 13.3 +/- 4.3, p less than 0.01). Again, Ensure Plus (strawberry) received the highest score from both groups (Ca 17.0 +/- 3.5 vs Co 17.8 +/- 2.3, NS), while Vital was rated lowest by both groups (Ca 5.6 +/- 4.7 vs Co 4.3 +/- 5.0, NS). The modified wine-tasting scale provides a method for quantitating taste preference for various dietary supplements. We report here the numerical rating of 11 supplements by patients with lung cancer and patients with breast cancer as well as their age- and sex-matched controls.

Efficacy of tube feeding in supplying energy requirements of hospitalized patients.

During a 6-week period, all adult patients in a university hospital receiving ready-to-feed nasoenteric tube feeding formula were prospectively studied. The study objective was to determine each patient's caloric intake from tube feeding relative to their energy needs and to identify factors causing decreased feeding intake. Each of 35 patients was visited at least once daily to determine their volumetric intake of tube feeding formula. Daily review of patient care records and nursing interviews were used to identify interruptions in therapy. Patient's basal energy expenditures (BEE) were calculated using the Harris-Benedict equation. Calorie goals were set by members of the Nutrition Support Service or clinical dietitians. Intakes averaged 1095 +/- 41 Kcal (SEM) per day or 61% of their mean calorie goal of 1791 +/- 41 Kcal. Mean daily calorie intake was statistically different (p less than 0.05) from mean energy goal on patient study days 1 through 5, 7, and 8. Only 16 of the 35 patients achieved an intake of 100% of their energy goal on any day of therapy. Calorie goals averaged 1.4 times BEE. Mean daily calorie intake did not exceed BEE until study day 10. Eighteen % of potential feeding time was lost due to temporary feeding interruptions; primarily inadvertent extubation (4.6%), gastrointestinal intolerance (4.7%), medical procedures requiring discontinuation of feeding (2.8%), and feeding tube positioning difficulties (1.5%). In addition, physicians ordered only 75% of calculated energy goals. These data indicate that tube feeding therapy, when provided under usual hospital conditions, does not meet patient's energy requirements.

Endosseous dental implants in orthodontic therapy.

This paper presents cases in which endosseous titanium implants are used in orthodontic treatment as an alternative method of providing anchorage, as well as solving prosthodontic problems, and shows that such an approach can be successful.