The relevance of false positive acid phosphatase reactions indicative of the presence of seminal fluid from oral and vaginal samples.

The Body Fluid Forum of the Association of Forensic Science Providers recognised concerns raised by forensic practitioners regarding the lack of data to inform on the incidence of significant AP (Acid Phosphatase) reactions from vaginal and oral samples, i.e. those which might be misinterpreted as indicating the presence of semen. This is particularly relevant in the light of appeal court rulings regarding the need for data to support evaluations. This paper presents collaborative data on the nature and incidence of AP reactions from vaginal and oral swabs provided by donors. The results demonstrate that caution is required with mid to strong purple AP reactions from direct testing of oral swabs and with mid purple reactions from vaginal swabs. The use of a Bayesian approach to assist with the provision of opinions regarding the presence of seminal fluid is highlighted.

Background levels of body fluids and DNA on the shaft of the penis and associated underpants in the absence of sexual activity.

This study examines the background of blood, saliva, semen and autosomal DNA on penile swabs and underpants from males in the absence of recent sexual activity. Based on the data collected by the AFSP Body Fluid Forum, the results of this study show that; there is a very low expectation of detecting blood on penile swabs and male underpants; a low expectation of detecting saliva on penile swabs and male underpants; and spermatozoa would be expected in less than a quarter of penile swabs and three quarters of male underpants. As none of the samples had detectable levels of DNA which were suitable for meaningful comparison that did not match the donor or their partner, the expectation of detecting a DNA profile from the cellular background on penile swabs or underpants from a male who has not been involved in recent sexual intercourse is very low. The results of this study are extremely informative when evaluating the significance of blood, saliva, semen and DNA detected on the penile swabs and underpants of males in cases of alleged sexual assault.

A cross-sectional study of walking, balance and upper limb assessment scales in people with cervical dystonia.

Cervical dystonia (CD) is a neurological movement disorder causing the neck to move involuntarily away from the neutral position. CD is a network disorder, involving multiple brain areas and, therefore, may impair movement in parts of the body other than the neck. This study used clinical assessments to investigate walking, balance and upper limb function (UL) in people with CD; the reliability of scoring these assessments and examined for relationship between CD severity, usual exercise and clinical assessments. We conducted a prospective observational cohort study of participants with isolated, focal, idiopathic CD. Participants were assessed by experienced physiotherapists and completed three questionnaires and eight clinical assessments of fear of falling, balance confidence, walking, balance, UL function and usual exercise. Results were compared to published data from healthy adults and other neurological populations. Twenty-two people with mild to moderate CD participated. Fear of falling, gross UL function and usual exercise were worse in people with CD compared with healthy adults, while walking, balance and distal UL function were similar to healthy populations. All assessments were reliably performed by physiotherapists, and we found no correlations between the severity of dystonia or usual exercise and performance on the physical assessments. Routine performance of clinical assessment of walking and balance are likely not required in people with mild to moderate CD; however, fear of falling and gross upper limb function should be assessed to determine any problems which may be amenable to therapy.

Combined Atomic Force Microscope and Volumetric Light Sheet System for Correlative Force and Fluorescence Mechanobiology Studies.

The central goals of mechanobiology are to understand how cells generate force and how they respond to environmental mechanical stimuli. A full picture of these processes requires high-resolution, volumetric imaging with time-correlated force measurements. Here we present an instrument that combines an open-top, single-objective light sheet fluorescence microscope with an atomic force microscope (AFM), providing simultaneous volumetric imaging with high spatiotemporal resolution and high dynamic range force capability (10 pN - 100 nN). With this system we have captured lysosome trafficking, vimentin nuclear caging, and actin dynamics on the order of one second per single-cell volume. To showcase the unique advantages of combining Line Bessel light sheet imaging with AFM, we measured the forces exerted by a macrophage during FcɣR-mediated phagocytosis while performing both sequential two-color, fixed plane and volumetric imaging of F-actin. This unique instrument allows for a myriad of novel studies investigating the coupling of cellular dynamics and mechanical forces.

Effects of nicotine exposure on murine mandibular development.

Nicotine is known to affect cell proliferation and differentiation, two processes vital to proper development of the mandible. The mandible, the lower jaw in mammals and fish, plays a crucial role in craniofacial development. Malformation of the jaw can precipitate a plethora of complications including disrupting development of the upper jaw, the palate, and or impeding airway function. The purpose of this study was to test the hypothesis that in utero nicotine exposure alters the development of the murine mandible in a dose dependent manner. To test this hypothesis, wild type C57BL6 mice were used to produce in utero nicotine exposed litters by adding nicotine to the drinking water of pregnant dams at concentrations of 0 µg/ml (control), 50 µg/ml (low), 100 µg/ml (medium), 200 µg/ml (high) throughout pregnancy to birth of litters mimicking clinically relevant nicotine exposures. Resultant pups revealed no significant differences in body weight however, cephalometric investigation revealed several dimensions affected by nicotine exposure including mandibular ramus height, mandibular body height, and molar length. Histological investigation of molars revealed an increase in proliferation and a decrease in apoptosis with nicotine exposure. These results demonstrate the direct effects of nicotine on the developing mandible outside the context of tobacco use, indicating that nicotine use including tobacco alternatives, cessation methods, and electronic nicotine delivering products may disrupt normal growth and development of the craniofacial complex.

Understanding the impetus for major systems change: A multiple case study of decisions and non-decisions to reconfigure emergency and urgent care services.

OBJECTIVE: The optimal organisation of emergency and urgent care services (EUCS) is a perennial problem internationally. Similar to other countries, the Health Service Executive in Ireland pursued EUCS reconfiguration in response to quality and safety concerns, unsustainable costs and workforce issues. However, the implementation of reconfiguration has been inconsistent at a regional level. Our aim was to identify the factors that led to this inconsistency. METHODS: Using a multiple case study design, six case study regions represented full, partial and little/no reconfiguration at emergency departments (EDs). Data from documents and key stakeholder interviews were analysed using a framework approach with cross-case analysis. RESULTS: The impetus to reconfigure ED services was triggered by patient safety events, and to a lesser extent by having a region-specific plan and an obvious starting point for changes. However, the complexity of the next steps and political influence impeded reconfiguration in several regions. Implementation was more strategic in regions that reconfigured later, facilitated by clinical leadership and "lead-in time" to plan and sell changes. CONCLUSION: While the global shift towards centralisation of EUCS is driven by universal challenges, decisions about when, where and how much to implement are influenced by local drivers including context, people and politics. This can contribute to a public perception of inequity and distrust in proposals for major systems change.

Relationship between Pharmacokinetics and Pharmacodynamic Responses in Healthy Smokers Informs a Once-Daily Dosing Regimen for Nemiralisib.

Nemiralisib (GSK2269557), a potent inhaled inhibitor of phosphoinositide 3-kinase δ (PI3Kδ), is being developed for the treatment of respiratory disorders including chronic obstructive pulmonary disease. Determining the pharmacokinetic (PK) and pharmacodynamic (PD) responses of inhaled drugs early during drug development is key to informing the appropriate dose and preferred dose regimen in patients. We set out to measure PD changes in induced sputum in combination with drug concentrations in plasma and bronchoalveolar lavage (BAL) taken from healthy smokers (n = 56) treated for up to 14 days with increasing doses of inhaled nemiralisib (0.1-6.4 mg). Induced sputum analysis demonstrated a dose-dependent reduction in phosphatidylinositol-(4,5)-trisphosphate (PIP3, the product of PI3K activation), with a maximum placebo-corrected reduction of 23% (90% confidence interval [CI], 11%-34%) and 36% (90% CI, 11%-64%) after a single dose or after 14 days of treatment with nemiralisib, respectively (2 mg, once daily). Plasma analysis suggested a linear PK relationship with an observed accumulation of ∼3- to 4.5-fold (peak vs. trough) in plasma exposure after 14 days of nemiralisib treatment. The BAL analysis at trough confirmed higher levels of the drug in the lungs versus plasma (32-fold in the BAL fluid component, and 214-fold in the BAL cellular fraction). A comparison of the drug levels in plasma and the reductions in sputum PIP3 showed a direct relationship between exposure and PIP3 reduction. These results demonstrated target engagement upon treatment with inhaled nemiralisib and provide confidence for a once-daily dosing regimen.

[Reconstruction using the tensor fasciae latae muscle flap]. / Defektdeckung mit Musculus-tensor-fasciae-latae-Lappen.

OBJECTIVE: The tensor fasciae latae (TFL) muscle flap can be used for reconstruction of decubital ulcers in the trochanteric or ischial region. INDICATIONS: Deep decubital ulcers in the gluteal or ischial area after debridement and exhaustion of conservative measures. CONTRAINDICATIONS: Moribund or palliative patients who do not benefit from defect coverage and are likely to suffer a life-threatening complication. Noncompliant patients who cannot follow the postoperative recommendations or protocols in regard to positioning or recurrence prevention. The presence of extensive scars after previous operations in the donor area or irradiation of the donor area can lead to flap necrosis. SURGICAL TECHNIQUE: The TFL flap is commonly used as a regional transposition flap. Rare cases of a free TFL flap have been described. POSTOPERATIVE MANAGEMENT: Following surgery the patient needs to be positioned on the side or prone to prevent recurrence. Drains should be left for 5-7 days. Antibiotics are only needed in the case of persistent florid infection. RESULTS: The TFL muscle flap is known to be a reliable flap for the coverage of ulcers in the ischial and trochanteric region following radical debridement. This flap can also be transferred with its sensitive nerve supply resulting in a reduced chance of a recurring ulcer.

[Flap coverage using the posterior gluteal thigh flap]. / Defektdeckung mit posteriorem Oberschenkellappen.

OBJECTIVE: Defect coverage of the sacral, trochanteric or ischial region with durable tissue (gluteal thigh flap). INDICATIONS: Decubital ulcers of the sacral, trochanteric or ischial region after exhaustion of conservative measures. CONTRAINDICATIONS: Moribund or palliative patients who do not benefit from defect coverage and are likely to suffer a life-threatening complication. Noncompliant patients, who cannot follow the postoperative recommendations or protocols in regard to positioning or recurrence prevention. The presence of extensive scars after previous operations in the donor area or irradiation of the donor area can lead to flap necrosis. SURGICAL TECHNIQUE: The posterior gluteal thigh flap can either be used as a fasciocutaneous flap or in combination with the gluteus muscle as myofasciocutaneous flap. Further microsurgical transfers have been described. POSTOPERATIVE MANAGEMENT: Following surgery the patient needs to be positioned on the side or prone to prevent recurrence. Drains should be left for 5-7 days. Antibiotics are only needed in the case of persistent florid infection. RESULTS: The posterior gluteal thigh flap is a well-known, reliable and versatile option for coverage of decubital ulcers in the sacral and ischial region with low recurrence rates described in the literature.

[Defect coverage using gluteal flaps]. / Defektdeckung durch Gluteuslappen.

OBJECTIVE: Gluteal skin, fasciocutaneous and myocutaneous flaps can be used to cover decubitus ulcers in the sacral and ischiocrural area. INDICATIONS: Decubitus ulcers in the sacral or ischial area that do not heal after exhausted conservative therapy. CONTRAINDICATIONS: Moribund patients who are very likely to suffer a life-threatening complication. Non-cooperative patients who cannot follow the postoperative recommendations. The presence of extensive scars after previous operations in the donor area or irradiation of the donor area which may compromise the flap perfusion. SURGICAL TECHNIQUE: A distinction is made between local skin flaps, perforator-based fasciocutaneous flaps and the myocutaneous gluteus maximus flap. By partial or complete elevation of the gluteus maximus muscle based on the superior and inferior gluteal vessels, this flap is useful for larger and deep defects in the sacral and ischial region. For more superficial defects, fasciocutaneous perforator flaps might be used. Smaller ulcers can be treated with local skin flaps. The donor site should be closed primarily. POSTOPERATIVE MANAGEMENT: Consistent, postoperative relief by prone and lateral positioning of the patient, avoiding new decubitus ulcers. Drainage for at least 5-7 days. Antibiotic therapy is indicated only with appropriate detection of pathogens and in case of persistent infection. RESULTS: With distinct anatomical and improved technical knowledge, the use of fasciocutaneous and myocutaneous flaps in the gluteal region is now an established procedure and can be used for reliable coverage of sacral and ischiocrural decubitus ulcers.

Perspectives on the underlying drivers of urgent and emergency care reconfiguration in Ireland.

BACKGROUND: There is an increasing tendency to reconfigure acute hospital care towards a more centralised and specialised model, particularly for complex care conditions. Although centralisation is presented as "evidence-based", the relevant studies are often challenged by groups which hold perspectives and values beyond those implicit in the literature. This study investigated stakeholder perspectives on the rationale for the reconfiguration of urgent and emergency care in Ireland. Specifically, it considered the hypothesis that individuals from different stakeholder groups would endorse different positions in relation to the motivation for, and goals of, reconfiguration. METHODS: Documentary analysis of policy documents was used to identify official justifications for change. Semi-structured interviews with 175 purposively sampled stakeholders explored their perspectives on the rationale for reconfiguration. RESULTS: While there was some within-group variation, internal and external stakeholders generally vocalised different lines of argument. Clinicians and management in the internal stakeholder group proposed arguments in favour of reconfiguration based on efficiency and safety claims. External stakeholders, including hospital campaigners and local political representatives expressed arguments that focused on access to care. A "voter" argument, focused on the role of local politicians in determining the outcome of reconfiguration planning, was mentioned by both internal and external stakeholders, often in a critical fashion. CONCLUSION: Our study adds to an emerging literature on the interaction between a technocratic approach to health system planning advocated by clinicians and health service managers, and the experiential "non-expert" claims of the public and patients.

Validation of Fear of Falling and Balance Confidence Assessment Scales in Persons With Dystonia.

BACKGROUND AND PURPOSE: Falls are problematic for people living with neurological disorders and a fear of falling can impact on actual falls. Fear of falling is commonly assessed using the Falls Self-Efficacy Scale International (FES-I) or the Activities-specific Balance Confidence (ABC) Scale. These scales can predict risk of falling. We aimed to validate the FES-I and the ABC in persons with dystonia. METHODS: We conducted an online survey of people with dystonia, collecting information on demographics, 6-month falls history, dystonia disability, and the FES-I and ABC scales. Scales were validated for structural validity and internal consistency. We also examined goodness-of-fit, convergent validity, and predictive validity, and determined cutoff scores for predicting falls risk. RESULTS: Survey responses (n = 122) showed that both FES-I and ABC scales have high internal validity and convergent validity with the Functional Disability Questionnaire in persons with dystonia. Each scale examines a single factor, fear of falling (FES-I) and balance confidence (ABC). At least one fall was reported by 39% of participants; the cutoff value for falls risk was found to be 29.5 and 71.3 for the FES-I and the ABC respectively. DISCUSSION AND CONCLUSIONS: The FES-I and the ABC scales are valid scales to examine fear of falling and balance confidence in persons with dystonia. Fear of falling is high and balance confidence is low and both are worse in those with dystonia who have previously fallen.Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A182).

Regulatory experience of TOPS: an internet-based system to prevent healthy subjects from over-volunteering for UK clinical trials.

PURPOSE: The aim was to review the use of The Over-volunteering Prevention System (TOPS) since the HRA began hosting it in 2013, and the Medicines and Healthcare products Regulatory Agency (MHRA) experience of monitoring its use by UK clinical research units. METHODS: The HRA searched the TOPS database for the number, type and location of units and the number of entries. The MHRA inspectors reviewed their findings from routine inspections. RESULTS: Twenty-two additional UK units registered to use TOPS during 2013-2016, making a total of 84 units since TOPS was established in 2002. Use of TOPS is now a condition of research ethics committee approval of a phase 1 study and fulfils MHRA accreditation requirements for preventing over-volunteering. The total number of entries by all active units during 2013-2016 was 89,335, of which 84% were UK citizens and 16% non-UK citizens. The total number of entries during 2002-2016 was 249,612. Only 15 of 24,531 subjects (1/1600) and 18 of 18,745 subjects (1/1040) entered in 2015 and 2016, respectively, were deemed potential over-volunteers. CONCLUSIONS: The findings continue to support the concept that TOPS not only helps to prevent over-volunteering, but also deters subjects from trying to do so. Regulation of TOPS by the HRA and MHRA has enhanced its effectiveness, benefited all users and helped to improve the safety of volunteers who participate in non-therapeutic trials in the UK. The UK is still the only country with a national database to prevent over-volunteering that has published data on its widespread use and effectiveness.

A novel inhaled phosphodiesterase 4 inhibitor (CHF6001) reduces the allergen challenge response in asthmatic patients.

CHF6001 is an inhaled phosphodiesterase 4 (PDE4) inhibitor in development for the treatment of obstructive lung diseases. The efficacy and safety of CHF6001 were investigated in a double blind, placebo controlled, 3-way cross-over study using the allergen challenge model. Thirty-six atopic asthmatics who were not taking inhaled corticosteroids and who demonstrated a late asthmatic response (LAR) to inhaled allergen at screening were randomised to receive CHF6001 400 µg or 1200 µg or placebo administered once a day using a dry powder inhaler. The three treatment periods were 9 days; allergen challenges were performed on day 9 and induced sputum was obtained after 10 h from challenge. Washout periods between treatments were up to 5 weeks. Both CHF6001 doses significantly attenuated the LAR; the primary endpoint analysis showed that CHF6001 400 µg and 1200 µg caused reductions of 19.7% (p = 0.015) and 28.2% (p < 0.001) respectively of the weighted FEV1 AUC4-10h compared with placebo. The difference between the CHF6001 doses was not statistically significant (p = 0.223). Compared with placebo, CHF6001 caused greater reduction in sputum eosinophil counts, although these changes were not statistically significant. CHF6001 was well tolerated, with similar numbers of adverse events in each treatment period. This inhaled PDE4 inhibitor has the potential to provide clinical benefits in patients with atopic asthma.

Safety, pharmacokinetics and pharmacodynamics of the anti-hepcidin Spiegelmer lexaptepid pegol in healthy subjects.

BACKGROUND AND PURPOSE: Anaemia of chronic disease is characterized by impaired erythropoiesis due to functional iron deficiency, often caused by excessive hepcidin. Lexaptepid pegol, a pegylated structured l-oligoribonucleotide, binds and inactivates hepcidin. EXPERIMENTAL APPROACH: We conducted a placebo-controlled study on the safety, pharmacokinetics and pharmacodynamics of lexaptepid after single and repeated i.v. and s.c. administration to 64 healthy subjects at doses from 0.3 to 4.8 mg·kg(-1) . KEY RESULTS: After treatment with lexaptepid, serum iron concentration and transferrin increased dose-dependently. Iron increased from approximately 20 µmol·L(-1) at baseline by 67% at 8 h after i.v. infusion of 1.2 mg·kg(-1) lexaptepid. The pharmacokinetics showed dose-proportional increases in peak plasma concentrations and moderately over-proportional increases in systemic exposure. Lexaptepid had no effect on hepcidin production or anti-drug antibodies. Treatment with lexaptepid was generally safe and well tolerated, with mild and transient transaminase increases at doses ≥2.4 mg·kg(-1) and with local injection site reactions after s.c. but not after i.v. administration. CONCLUSIONS AND IMPLICATIONS: Lexaptepid pegol inhibited hepcidin and dose-dependently raised serum iron and transferrin saturation. The compound is being further developed to treat anaemia of chronic disease.

The Effect of Bariatric Surgery on Urinary Incontinence in Women.

BACKGROUND: Little is known regarding the effect of bariatric surgery on urinary incontinence. METHODS: Between September 2008 and November 2014, 240 female patients underwent bariatric surgery. RESULTS: The prevalence of urinary incontinence preoperatively was 45 % (108). Eighty-two (76 %) completed urinary function questionnaires pre-operatively and post-operatively. Fifty-seven (70 %) underwent laparoscopic gastric bypass, twenty-four (29 %) underwent sleeve gastrectomy and one underwent a banding procedure. Thirty-one (38 %) reported leaking on sneezing or coughing-stress urinary incontinence (SUI). Thirteen (16 %) complained of leaking before reaching the toilet-overactive bladder syndrome (OAB). The remaining thirty-eight (46 %) reported mixed symptoms. The mean pre-operative weight and BMI were 133 (18) kg and 50 (SD = 6.2) kg/m(2) respectively. The mean post-operative BMI drop was 16 (SD = 5.2) kg/m(2). Preoperatively, 61 (75 %) reported moderate to very severe urinary incontinence compared to 30 (37 %) post-operatively (χ (2) = 3.24.67, p = 0.050). Twenty-seven (33 %) patients reported complete resolution of their urinary incontinence. Fifty-one (62 %) patients required incontinence pads on a daily basis pre-operatively, compared to 35 (43 %) post-operatively (χ (2) = 22.211.6, p = 0.00). The mean International Consultation on Incontinence Questionnaire- Urinary Incontinence short form (ICIQ-UI SF) score was 9.3 (SD = 4.4) pre-operatively compared to 4.9 (SD = 5.3) post-operatively (t = 7.2, p = 0.000). The improvement score post-operatively was 8 (SD = 3). A significant difference in the ICIQ-UI SF was identified between OAB and SUI groups when adjusting for age, number of children, type of delivery and pre-op BMI (t = 1.98, p = 0.05). CONCLUSION: Bariatric surgery results in a clinically significant improvement in urinary incontinence. However, this is not proportional to pre-operative BMI, weight loss, age, parity and mode of delivery.

Does an Early and Aggressive Combined Wrapping and Dangling Procedure Affect the Clinical Outcome of Lower Extremity Free Flaps?-A Randomized Controlled Prospective Study Using Microdialysis Monitoring.

Background The ideal starting point for flap training (FT) with the combined wrapping and dangling procedure is still a question of debate. Most units follow their own established protocols and currently evidence of flap compromise due to FT is still lacking. The aim of this study was to prove if an early and "aggressive" wrapping and dangling protocol could lead to metabolic changes, measured by microdialysis, indicating ischemia resulting in compromised flap perfusion. Methods Between 2010 and 2014, 49 patients with microvascular free flap reconstruction of the lower limb were included in this study. Patients were randomized into two groups. Group I started FT on the 7th postoperative day, and group II started on day 3. FT consisted of a combined wrapping and dangling procedure doubling its duration daily and ending at day 5. Flaps were monitored clinically and by microdialysis for ischemia-induced changes and metabolic parameters in the flap tissue in respect to different starting points of FT. Results All 49 patients in both groups were able to complete the postoperative FT without complications. Noninferiority of the early group could be proven and microdialysis results showed no differences between both groups. Conclusion We could prove by microdialysis that an early start of FT does not lead to compromised flap perfusion. Moreover, an early start of FT can lead to a reduced length of hospital stay. Furthermore, a reduced risk for deep vein thrombosis, pulmonary embolism, and pneumonia due to earlier mobilization might be an appreciated side effect.

Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles and an ADA Reference Toothbrush on Established Gingivitis and Supragingival Plaque over a 12-Week Period.

OBJECTIVES: Evaluation of the efficacy of a soft toothbrush with tapered-tip bristles (Test Toothbrush) and an ADA reference soft toothbrush (ADA Toothbrush) on established gingivitis and supragingival plaque over a 12-week period. METHODS: This randomized, single-center, examiner-blind, two-cell, parallel clinical research study assessed plaque removal by the comparison of pre- to- post-brushing after a single use, and again after six- and 12-weeks' use, using the Quigley-Hein Plaque Index, Turesky Modification. The study also assessed gingivitis after six weeks and 12 weeks using the Löe & Silness Gingival Index. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Subjects had the study procedure explained to them both orally and by written instructions. Subjects then gave written consent to participate before entry into the study. Following an examination for plaque (pre-brushing) and gingivitis (baseline), the subjects were randomized into two balanced groups, each group assigned to one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: Seventy-one (71) subjects complied with the protocol and completed the clinical study. Compared to the ADA Toothbrush, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 71.1% in whole mouth plaque index scores, 43.8% in plaque severity index scores, and 81.3% in interproximal sites plaque scores after a single tooth brushing. After six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 700% in whole mouth gingival index scores, 700% in gingivitis severity index scores, and 400% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 188.9% in whole mouth plaque index scores, 165% in plaque severity index scores, and 203% in interproximal sites plaque scores compared to the ADA Toothbrush. After 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 266.7% in whole mouth gingival index scores, 300% in gingivitis severity index scores, and 250% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 158.1% in whole mouth plaque index scores, 143.5% in plaque severity index scores, and 145.4% in interproximal sites plaque scores compared to the ADA Toothbrush. CONCLUSIONS: This study demonstrated that a soft toothbrush with tapered-tip bristles provided a significantly greater reduction in supragingival plaque after a single tooth brushing, as well as after six and 12 weeks of twice-daily use, compared to the ADA Toothbrush. After six and 12 weeks of twice-daily use, it also provided a significantly greater reduction in gingivitis as compared to the ADA Toothbrush.

Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles to an ADA Reference Toothbrush on Gingival Abrasion over a 12-Week Period.

OBJECTIVES: Evaluation of the impact of a soft toothbrush with tapered-tip (Test Toothbrush) bristles and an ADA reference toothbrush (ADA Toothbrush) on gingival abrasion over a 12-week period. METHODS: This was a randomized, single-center, examiner-blind, two-cell, parallel clinical research study and used the Danser Gingival Abrasion Index to assess the level of gingival abrasion after a single brushing, as well as after six weeks and 12 weeks of twice-daily brushing. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Following a qualifying examination using plaque and gingivitis scores along with a baseline gingival abrasion examination, subjects were randomized into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute, under supervision, with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for gingival abrasion. Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for gingival abrasion. RESULTS: Seventy-one (71) subjects complied with the protocol and completed the clinical study. The results of this study showed that the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions in gingival abrasion scores as compared to the gingival abrasion scores of the ADA Toothbrush after a single tooth brushing, after six weeks, and after 12 weeks of product use (75.0%, 85.5%, 73.9%, respectively). CONCLUSIONS: The soft toothbrush with tapered-tip bristles produced significantly less gingival abrasion after 12 weeks of product use as compared to the ADA reference toothbrush.

Efficacy of two fluoride-free, alcohol-free mouthwashes containing 0.075% or 0.07% CPC in controlling established dental plaque and gingivitis over a 6-week period on adults in Puerto Rico.

PURPOSE: To evaluate the clinical efficacy of two commercially available, fluoride-free, alcohol-free mouthwashes containing either 0.075% or 0.07% cetylpyridinium chloride (CPC) in controlling established dental plaque and gingivitis compared to a non-antibacterial control mouthwash. METHODS: A 6-week double-blind, randomized clinical trial was conducted in Trujillo Alto, Puerto Rico. Recruited subjects were randomly assigned to one of three treatment groups: (1) a fluoride-free, alcohol-free mouthwash containing 0.075% CPC (TG); (2) a fluoride-free, alcohol-free mouthwash containing 0.07% CPC (PC); and (3) a fluoride-free, alcohol-free mouthwash without antibacterial agent (NC). Subjects were instructed to rinse with the assigned mouthwash, after tooth brushing, twice daily (morning and evening). After 4 and 6 weeks of product use, subjects were examined for gingivitis (Whole Mouth Gingival, Gingival Interproximal, Gingival Severity Indexes) and plaque (Whole Mouth Plaque, Plaque Interproximal, and Plaque Severity Indexes) parameters. ANCOVA and post hoc Tukey's pair-wise comparisons (α = 0.05) were performed for treatment group comparisons. RESULTS: A total of 132 subjects were screened; 120 were enrolled; and 116 completed the study. After 6 weeks of product use, participants who rinsed with the CPC-containing mouthwashes exhibited statistically significant (P < 0.05) reductions in all the gingivitis and plaque parameters evaluated, whereas in those using the non-antibacterial mouthwash, significant reductions were only observed in whole mouth and interproximal plaque scores. No statistically significant (P > 0.05) differences were observed, with respect to the gingival and plaque parameters, between the two CPC-containing mouthwashes.