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Objectives The objective of this study is to clinically evaluate the outcomes following treatment of single gingival recessions with either coronally advanced flap technique (CAF) alone or combined with a porcine collagen matrix graft (CM). Materials and methods This is a randomized parallel design clinical trial, including forty patients with single Miller Class I or II gingival recession, with a depth ≥ 2 mm and located at upper canines or premolars. The patients were randomly assigned to receive either CAF or CAF + CM. The primary outcome variable was gingival recession reduction (Rec Red). Results Baseline recession depth was 3.14 ± 0.51 mm for CAF group and 3.16 ± 0.65 mm for CAF + CM group ( p  > 0.05). Both groups showed significant Rec Red ( p  < 0.05), up to 6 months. Rec Red for CAF + CM was 2.41 ± 0.73 mm and was 2.25 ± 0.50 mm for CAF alone ( p  > 0.05). Root coverage was 77.2 % in the CAF + CM group and 72.1 % in the CAF group ( p  > 0.05). Complete root coverage (CRC) was found in 40 % of the cases in the CAF + CM group and in 35 % of the sites treated with CAF. Keratinized tissue thickness (KTT) was 0.26 mm higher in CAF + CM group ( p  < 0.05). Conclusions It can be concluded that CAF + CM does not provide a superior recession reduction when compared to CAF; however, it may offer a small gain in KTT after 6 months. Clinical relevance CAF + CM can be suggested as a valid therapeutic option to achieve root coverage and some increase in soft tissue thickness after 6 months.

Purpose Disproportional fat-free mass loss often occurs post-bariatric surgery, partly due to insufficient protein intake during the post-surgery recovery phase. We compared five protein-enhancing strategies (PES) on patient tolerability, satisfaction and protein intake. Materials and Methods Ninety-four participants, scheduled for bariatric surgery, were enrolled and allocated to either of the following: (1) whey powder, (2) hydrolysed collagen powder, (3) plant-based powder, (4) protein-rich products, (5) protein gel, or control. PES groups were instructed to add 30 g of powder or 2 gels or protein products to their diet. Patient satisfaction and tolerability were evaluated with questionnaires. Dietary intake was assessed prior to and during PES use. Results Seven patients dropped out (i.e. loss of contact, personal reasons or post-surgery complications) yielding an analytical cohort of 87 participants. The majority of patients (61%) did not experience dietary complaints from PES and could use PES ≥ 5 days of the week. PES non-usage was mainly related to taste dislike (58%). Hydrolysed collagen scored highest on tolerability and satisfaction: 86% of the participants could use HC ≥ 5 days and 71% were satisfied with the product. PES increased protein intake from 54.7 ± 21.5 g/day to 64.7 ± 23.4 g/day during the intervention ( p  = 0.002), which differed from the control group (+ 10.1 ± 24.5 g/day vs. − 6.3 ± 23.8 g/day for controls, p  = 0.019). Whey showed the highest increase, namely + 18.3 ± 16.3 g/day ( p  = 0.009). Conclusion PES were tolerated by the majority of participants, and an improved protein intake with PES use was seen. However, the taste of the products could be improved to further enhance satisfaction and tolerability. Graphical Abstract

ObjectivesTo assess the clinical efficacy of xenogeneic collagen matrix (XCM) plus apically positioned flap (APF) in augmenting the keratinized mucosa (KM) width (KMW) and thickness (KMT) around posterior mandibular implants and compare it with free gingival graft (FGG) plus APF.Material and methodsThirty patients with KMW ≤ 2 mm in the posterior mandibular implant site were randomly allocated to the FGG group (FGG plus APF) or the XCM group (XCM plus APF). Clinical assessments, including KMW and KMT, shrinkage rate of established KM, and peri-implant soft tissue health, were evaluated during a 6-month follow-up. Additionally, the esthetic outcomes and patient-reported postoperative morbidity were investigated.ResultsAt 6 months, the KMW measured 3.60 ± 0.79 mm in the FGG group and 3.28 ± 0.96 mm in the XCM group (p = 0.186). Both groups showed a tendency for graft contraction (FGG, 42.11%; XCM, 53.22%). The KMT measured 1.24 ± 0.34 mm in the FGG group and 0.95 ± 0.29 mm in the XCM group, with statistical difference (p = 0.002). No difference in the peri-implant soft tissue health was observed between the two groups (p > 0.05), but the esthetic outcomes were better in the XCM group (p < 0.05).ConclusionsXCM plus APF rendered a similar clinical efficacy in augmenting KMW as that with FGG plus APF, but with higher shrinkage. XCM plus APF was inferior with respect to FGG plus APF in augmenting KMT. The esthetic outcomes were better with XCM plus APF than FGG plus APF.Clinical relevanceXCM plus APF graft was inferior with respect to FGG plus APF in augmenting KMT.Trial registrationTrial registration number: ChiCTR2200058027 and date: 03/27/2022.

Cell therapy may be helpful for cardiac disease but has been fraught with poor cell retention and survival after transplantation. To determine whether cell-laden hydrogel treatment is safe and feasible for patients with chronic ischemic heart disease (CIHD). This randomized, double-blind clinical trial was conducted between March 1, 2016, and August 31, 2019, at a single hospital in Nanjing, China. Among 115 eligible patients with CIHD, 50 patients with left ventricular ejection fraction of 45% or less were selected to receive elective coronary artery bypass grafting (CABG) and additionally randomized to cell-plus-collagen treatment (collagen/cell group), cell treatment alone (cell group), or a control group. Sixty-five patients were excluded because of severe comorbidities or unwillingness to participate. Forty-four participants (88%) completed the study. The last patient completed 12 months of follow-up in August 2019. Analyses were prespecified and included all patients with available data. During CABG, patients in the collagen/cell group were treated with human umbilical cord-derived mesenchymal stromal cell (hUC-MSC)-laden collagen hydrogel intramyocardial injection, and the cell group was treated with hUC-MSCs alone. Patients in the control group underwent CABG alone. The primary outcome was safety of the cell-laden collagen hydrogel assessed by the incidence of serious adverse events. The secondary end point was the efficacy of treatment, according to cardiovascular magnetic resonance imaging-based left ventricular ejection fraction and infarct size. Fifty patients (mean [SD] age, 62.6 [8.3] years; 38 men [76%]) were enrolled, of whom 18 were randomized to the collagen/cell group, 17 to the cell group, and 15 to the control group. Patient characteristics did not differ among groups at baseline. For the primary end point, no significant differences in serious adverse events, myocardial damage markers, and renal or liver function were observed among all groups after treatment; the collagen/cell and cell groups each had 1 case of hospitalization because of heart failure, and no serious adverse events were seen in the control group. At 12 months after treatment, the mean infarct size percentage change was -3.1% (95% CI, -6.20% to -0.02%; P = .05) in the collagen/cell group, 5.19% (-1.85% to 12.22%, P = .35) in the cell group, and 8.59% (-3.06% to 20.25%, P = .21) in the control group. This study provides, to our knowledge, the first clinical evidence that the use of collagen hydrogel is safe and feasible for cell delivery. These findings provide a basis for larger clinical studies. ClinicalTrials.gov Identifier: NCT02635464.

Background An adjunctive topical therapy with gentamicin-sponges to systemic antibiotic therapy might improve the healing of infected diabetic foot ulcers (DFUI). Methods Single-center, investigator-blinded pilot study, randomizing (1:1) the gentamicin-sponge with systemic antibiotic versus systemic antibiotics alone for patients with DFUI. Results We included 88 DFUI episodes with 43 patients in the gentamicin-sponge arm and 45 in the control arm. Overall, 64 (64/88; 73%) witnessed total clinical cure, 13 (15%) significant improvement, and 46 (52%) showed total eradication of all pathogens at the final visit. Regarding final clinical cure, there was no difference in favour of the gentamicin-sponges (26/45 vs. 31/43; p  = 0.16). However, the gentamicin-sponge arm tended to a more rapid healing. In multivariate analysis adjusting for the case-mix, the variable “gentamicin-sponge” was not significantly associated with “cure and improvement”. Gentamicin-sponges were very well tolerated, without any attributed adverse events. Conclusions The gentamicin-sponge was very well tolerated, but did not significantly influence overall cure. Trial registration ClinicalTrials.gov ( NCT01951768 ). Date 2 April 2013.

Background Genitourinary syndrome of menopause (GSM) includes clinical manifestations attributed to estrogen deficiency affecting the genitourinary tract of postmenopausal women. Treatment may require a multifaceted approach, including patient education, lifestyle modifications, physical, as well as hormonal and non‐hormonal therapies. Aims To evaluate the efficacy and tolerability of vaginal CO2 laser therapy (MonaLisa Touch) combined with an oral food supplement containing bioactive collagen peptides (BCP) and other functional components for GSM treatment. We hypothesized that this combination would enhance GSM symptom relief. Patients/Methods Twenty postmenopausal women with GSM were divided into two groups. Group 1 (n = 10) underwent three sessions of vaginal CO2 laser treatment alone, while Group 2 (n = 10) received the same laser treatment in addition to oral food supplementation. Improvements in vaginal health (Vaginal Health Index—VHI), vaginal pain (Visual Analogue Scale—VAS), and sexual function (Female Sexual Function Index—FSFI), along with patient satisfaction and tolerability, were evaluated. Results Both groups showed improvements in VHI, pain scores, and FSFI, with Group 2 displaying more significant gains. Compared to Group 1, Group 2 had greater median differences in VHI (Δ = 11.00 vs. Δ = 8.50, p = 0.005) and VAS (Δ = −7.00 vs. Δ = −5.50, p = 0.017). Similarly, FSFI scores increased meaningfully in both groups, more so in Group 2 (from 53.50 to 67.50, p = 0.005 vs. from 51.50 to 60.50, p = 0.014 in Group 1). Treatment satisfaction was also higher in Group 2 (p = 0.047). Conclusions The addition of oral supplementation with BCP and other functional components to vaginal CO2 laser treatment for GSM offered significant benefits over laser treatment alone, improving vaginal health, reducing pain, and ameliorating sexual function. This combination therapy presents a promising non‐hormonal option for GSM management, warranting further investigation in larger, long‐term studies to confirm these preliminary findings.

PurposeTo assess the refractive improvements and the corneal endothelial safety of an individualised topography-guided regimen for corneal crosslinking in progressive keratoconus.MethodsAn open-label prospective randomised clinical trial was performed at the Department of Clinical Sciences, Ophthalmology, Umeå University Hospital, Umeå, Sweden. Thirty-seven patients (50 eyes) with progressive keratoconus planned for corneal crosslinking were included. The patients were randomised to topography-guided crosslinking (photorefractive intrastromal crosslinking (PiXL); n=25) or uniform 9 mm crosslinking (corneal collagen crosslinking (CXL); n=25). Visual acuity, refraction, keratometry (K1, K2 and Kmax) and corneal endothelial morphometry were assessed preoperatively and at 1, 3, 6 and 12 months postoperatively. The PiXL treatment involved an asymmetrical treatment zone centred on the area of maximum corneal steepness with treatment energies ranging from 7.2 to 15.0 J/cm2; the CXL treatment was a uniform 9 mm 5.4 J/cm2 pulsed crosslinking. The main outcome measures were changes in refractive errors and corneal endothelial cell density.ResultsThe spherical refractive errors decreased (p<0.05) and the visual acuity improved (p<0.01) at 3, 6 and 12 months after PiXL, but not after CXL. The between-groups differences, however, were not significant. K2 and Kmax decreased at 3, 6 and 12 months after PiXL (p<0.01), but not after CXL (p<0.01 when comparing the two treatments). No corneal endothelial cell loss was seen after either treatment.ConclusionsIndividualised topography-based crosslinking treatment centred on the ectatic cone has the potential to improve the corneal shape in keratoconus with decreased spherical refractive errors and improved visual acuity, without damage to the corneal endothelium.Trial registration numberNCT02514200, Results.

The aim of the study was to assess the effectiveness of fish skin collagen and its impact on healing, pain intensity, and quality of life in patients with venous leg ulcers (VLUs). This study included 100 adults with VLUs. Eligible patients were randomized to either tropocollagen gel treatment (group A, n = 47) or placebo alone (group B, n = 45). We applied the gel to the periwound skin for 12 weeks. All groups received standard wound care, including class 2 compression therapy and wound hygiene procedures. We assessed the healing rate (cm2/week) and quality of life (QoL) using the Skindex-29 and CIVIQ scales. In group A, more ulcers healed, and the healing rate was faster. In both study groups, patients showed a significant improvement in quality of life after the intervention, but there was a greater improvement in the tropocollagen group. In group A, the greatest improvement was related to physical symptoms and the pain dimension. This study showed that the application of fish collagen gel to the periwound skin improves the healing process and QoL in patients with VLUs. The 12-week treatment with collagen reduced the severity of physical complaints, pain, and local skin symptoms, which determined the quality of life in patients with VLUs to the greatest extent.

Chronic pain affects 19% of adults in the United States, with increasing prevalence in active and aging populations. Pain can limit physical activity and activities of daily living (ADLs), resulting in declined mental and social health. Nutritional interventions for pain currently target inflammation or joint health, but few influence both. Collagen, the most abundant protein in the human body and constituent of the extra cellular matrix, is such a nutraceutical. While there have been reports of reductions in pain with short-term collagen peptide (CP) supplementation, there are no long-term studies specifically in healthy middle-aged active adults. To determine the effects of daily CP consumption over 3, 6, and 9 months on survey measures of pain, function, and physical and mental health using The Knee Injury & Osteoarthritis Outcomes Score (KOOS) and Veterans Rand 12 (VR-12) in middle-aged active adults. This study was a double-blind randomized control trial with three treatment groups (Placebo, 10 g/d CP, and 20 g/d CP). Improvements in ADLs (  = .031, η  = .096) and pain (  = .037, η  = .164) were observed with 10 g/d CP over 6 months, although pain only improved in high frequency exercisers (>180 min/week). Additionally, VR-12 mental component scores (MCS) improved with 10 g/d of CP over 3-9 months (  = .017, η  = .309), while physical component scores (PCS) improved with 20 g/d of CP over 3-9 months, but only in females (  = .013, η = .582). These findings suggest 10 to 20 g/d of CP supplementation over 6 to 9 months may improve ADLs, pain, MCS, and PCS in middle-aged active adults.