bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparative antiplaque and antigingivitis effectiveness of a chlorhexidine and an essential oil mouthrinse: 6‐month clinical trial
Authors: Charles C. H. , Mostler K. M. , Bartels L. L. , Mankodi S. M. 
Published: September 2004

AbstractObjectives: The objective of this study was to compare the antiplaque and antigingivitis effectiveness and the side‐effect profiles of an essential oil‐containing mouthrinse and a chlorhexidine‐containing mouthrinse.Material and Methods: One hundred and eight qualifying subjects, aged 20–57 years, were randomized into three groups: essential oil mouthrinse (Listerine® Antiseptic); 0.12% chlorhexidine mouthrinse (Peridex®); or 5% hydroalcohol negative control. At baseline, subjects received a complete oral soft tissue examination and scoring of the Loe–Silness gingival index (GI), Quigley–Hein plaque index (PI), Volpe–Manhold calculus index (CI), and Lobene extrinsic tooth stain index (SI). Following a complete dental prophylaxis, subjects started rinsing twice daily with their respective mouthrinse as an adjunct to their usual mechanical oral hygiene procedures. One of the rinses on each weekday was supervised. Subjects were reexamined at 3 and 6 months.The treatment groups were compared with respect to baseline demographic and clinical variables. The primary efficacy variables were GI and PI. Intergroup differences for all clinical variables were tested at 3 and 6 months using appropriate statistical procedures.Results: All of the 108 randomized subjects were evaluable at 3 months, and 107 subjects were evaluable at 6 months. There were no statistically significant differences among the three groups at baseline, with the exception that the control group PI was significantly lower than that of the essential oil group (p<0.05) and the chlorhexidine group (p<0.001), and the essential oil mouthrinse group had a significantly greater number of subjects than the control group with body region SI scores 1.0 (p=0.021). At 6 months, the essential oil and chlorhexidine mouthrinses produced statistically significant (p<0.001) GI reductions of 14.0% and 18.2%, respectively, and statistically significant (p<0.001) PI reductions of 18.8% and 21.6%, respectively, compared with the control and were not statistically significantly different from each other with respect to plaque and gingivitis reduction. The chlorhexidine mouthrinse group had significantly more calculus and extrinsic tooth stain than either the essential oil mouthrinse group or the control group.Conclusion: This 6‐month controlled clinical study demonstrated that the essential oil mouthrinse and the chlorhexidine mouthrinse had comparable antiplaque and antigingivitis activity. Insofar as side effects associated with the chlorhexidine mouthrinse may limit patient compliance, it is suggested that each product can have a distinct role in the management of patients with periodontal diseases.
Plaque removal by professional electric toothbrushing compared with professional polishing
Authors: Van der Weijden G. A. , Timmerman M. F. , Piscaer M. , IJzerman Y. , Van der Velden U. 
Published: September 2004

AbstractObjectives:This parallel examiner blind study was designed to compare the results of professional brushing with an electric toothbrush (ETB, Braun Oral‐B 3D Excel) to a professional polish session.Material and Methods:For this study, 90 non‐dental students were selected. All received a single oral prophylaxis where plaque and calculus were removed and the teeth were polished so that all subjects started with equally clean teeth. Approximately 4 weeks later the subjects received a new appointment prior to which they were asked to abstain from oral hygiene procedures for at least 48 h. At baseline the examiner (M.P.) evaluated the amount of dental plaque (Sillness & Löe) at six surfaces of each tooth. Subsequently, in the absence of this examiner, the subject's teeth were brushed or polished by a dental hygienist (Y.I.J.). Three groups were formed; the subjects in Group 1 received 10 min of polishing with a rubber cup/point using dentifrice as abrasive paste, in Group 2 subjects were brushed for 2 min with an ETB and dentifrice by the hygienist and in Group 3 brushing for 10 min was performed with an ETB and dentifrice. Care was taken to call upon the examiner always >10 min after her leaving the room so that she was unaware of the treatment. Electric brushing was carried out carefully following the contour of the teeth and turning the brush head separately in the direction of the mesial and distal aspect of each tooth in each approximal space. After finishing with the brushing/polishing, the examiner re‐evaluated the amount of remaining dental plaque.Results:The baseline plaque levels in Groups 1–3 were 1.54, 1.62 and 1.55, respectively. The reduction in plaque scores in Group 1 was 94.8% (±4.0), for Group 2 94.2% (±4.7) and for Group 3 99.4% (±0.5). The results in Group 3 were significantly better than in Groups 1 and 2. Explorative analysis revealed that these differences were due to a higher plaque removal from the approximal surfaces and molars.Conclusion:Two minutes of professional brushing with an ETB was as effective as 10 min of professional polishing. Whereas 10 min with an ETB was even more effective.
Evaluation of a new periodontal probe tip design
Authors: Vartoukian S. R. , Palmer R. M. , Wilson R. F. 
Published: September 2004

AbstractAims: In the search for an accurate periodontal probe which does not frequently penetrate the pocket base, a new tip has been designed which is flattened, and of 1 mm width and 0.45 mm thickness. This study aimed to evaluate the physico‐mechanical and clinical properties of this probe (test) in comparison to a conventional 0.5 mm circular probe (control).Methods: Photoelastic stress analysis was undertaken for test and control probe tips at 3.15 and 5 N loads. To assess probing validity, the clinical probing depth with each probe (0.25 N force) at 125 sites on 27 teeth (27 subjects), was compared with the post‐extraction connective tissue level measurement. Also evaluated were probing reproducibility (1200 sites in 25 subjects) and patient comfort (30 subjects).Results: Using photoelastic stress analysis, the test probe demonstrated lower stresses and less local stress concentration than the control. Clinically, the test probe measured close to the post‐extraction gold standard in greater frequency than the control – 26 versus 11 readings (21% versus 9%) exactly matched, and 90 versus 67 (72% versus 54%) were within ±0.5 mm of the laboratory measurement. The test probe was, on average, 0.13 mm coronal to the connective tissue attachment level, whereas the control penetrated 0.27 mm past this level. The intraclass correlation between clinical and laboratory readings was greater for the test than the control (r=0.81 and 0.74, respectively). Although the control probe overestimated probing depth more markedly at bleeding (0.41 mm) than at non‐bleeding (0.15 mm) sites, the relative position of the test probe hardly differed with inflammatory status (−0.11 and −0.14 mm, respectively). Each probe demonstrated good clinical reproducibility. However, the test probe examination was more comfortable for the patient.Conclusion: This new periodontal probe tip appears to have greater validity, good reproducibility and produces less patient discomfort.
HLA‐G Expression in Placenta in Relation to HLA‐G Genotype and Polymorphisms
Authors: Hviid Thomas Vauvert F. , Larsen Lise Grupe , Hoegh Anne Mette , Bzorek Michael 
Published: September 2004

Problem:  The expression of the non‐classical human leukocyte antigen (HLA) class Ib gene, HLA‐G, seems to be important at the feto–maternal interface. The HLA‐G molecule is almost monomorphic and expressed in both membrane‐bound and soluble isoforms. It has been shown to inhibit natural killer cell ‐mediated lysis and influence cytokine expression. HLA‐G gene polymorphism has been linked to differences in gene expression profile of alternatively spliced HLA‐G transcripts and levels of specific HLA‐G messenger RNA (mRNA) isoforms. Furthermore, aberrant HLA‐G expression has been reported in preeclamptic placentas. On this background it is of general interest to further elucidate any associations between HLA‐G polymorphism and protein expression.Methods:  We have investigated HLA‐G protein expression by immunohistochemistry in HLA‐G genotyped placentas from term. HLA‐G mRNA expression in preeclamptic placentas and in control placentas was also studied by microarray technology.Results and conclusions:  The studies of HLA‐G protein expression in term placentas by immunohistochemical analysis showed no clear associations with HLA‐G genotypes although this could be because of the very semi‐quantitative nature of this technique. However, we found a tendency towards reduction of HLA‐G mRNA expression in placentas from preeclamptic cases compared to matched controls with the use of microarray technology.
The Placental Immunomodulatory Cytokine Regeneration and Tolerance Factor is also Expressed by Both Human Cycling and Early Pregnant Endometrium
Authors: Lattuada Debora , Mangioni Silvia , Viganò Paola , Ntrivalas Evangelos I. , Rossi Margherita , Palotti Francesco , Carinelli Silvestro , Beaman Kenneth D. , Di Blasio Anna M. 
Published: September 2004

Problem:  Regeneration and tolerance factor (RTF) has been recently suggested to contribute to the control of fetal‐ablating immunity at the maternal–fetal interface through the induction of T helper 2 (Th2)‐dominated response. The protein consists of a membrane‐associated domain and an extracellular portion which is proteolitically cleaved to yield a soluble peptide. In humans, it has been shown to be expressed by invading cytotrophoblasts and decidual lymphoid cells, to be increased on peripheral blood B lymphocytes during a normal gestation and on circulating natural killer cells during unsuccessful pregnancies. However, the expression of RTF in other cell types and, specifically, in non‐hematopoietic maternal cells of the human uterus has not been characterized in detail. Thus, we have specifically studied the expression and modulation of the cytokine in human endometrium obtained in different phases of the cycle and in early pregnancy.Methods:  The 20 kDa extracellular domain of RTF has been localized by immunohistochemical method and Western blot analysis. Levels of RTF messenger RNA (mRNA) in basal and stimulated conditions have been evaluated by semiquantitative reverse transcription‐polymerase chain reaction.Results:  The extracellular domain of RTF could be detected in both the glandular epithelium and stroma with diffuse distribution in both cycling endometrium and first trimester decidua. Both cycling and pregnant endometrium expressed the gene for RTF but mRNA levels resulted significantly increased in secretory phase‐endometrial stromal cells when compared to proliferative phase samples. Inflammatory cytokines, interleukin‐1β and tumour necrosis factor α were able to directly increase endometrial RTF mRNA expression.Conclusion:  These results indicate that RTF is constitutively expressed at endometrial and decidual level and its up‐regulation during the secretory phase of the cycle may be relevant in mediating some immune‐related aspects of uterine physiology.
Pharmacotherapy for Erectile Dysfunction
Authors: Padma-Nathan Harin , Christ George , Adaikan Ganesan , Becher Edgardo , Brock Gerald , Carrier Serge , Carson Culley , Corbin Jackie , Francis Sharon , DeBusk Robert , Eardley Ian , Hedlund Hans , Hutter Adolph , Jackson Graham , Kloner Robert , Lin Shin , McVary Kevin , McCullough Andrew , Nehra Ajay , Porst Hartmut , Schulman Claude , Seftel Allen , Sharlip Ira , Stief Christian , Teloken Claude 
Published: September 2004

ABSTRACT

Introduction
Advances in understanding of the biochemistry and physiology of penile erection have led to breakthroughs in pharmacotherapy of erectile dysfunction.

Aim
To provide recommendations/guidelines concerning state-of-the-art knowledge for the putative molecular and cellular mechanisms of action of centrally and peripherally acting drugs currently utilized in pharmacotherapy of erectile dysfunction.

Methods
An international consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a two-year period. Concerning the Pharmacotherapy for Erectile Dysfunction Committee there were 25 experts from 10 countries.

Main Outcome Measure
Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate.

Results
Selective and potent oral PDE5 inhibitors have significantly more affinity than cGMP and form broader molecular interactions with multiple amino acids, thereby blocking access to cGMP in the catalytic sites of the PDE5 enzyme. PDE5 inhibitors, which vary as to biochemical potency, selectivity and pharmacokinetics, lead to cGMP elevation and relaxation facilitation of penile corpus cavernosum smooth muscle cells following sexual stimulation. Various centrally acting drugs influence sexual behaviour. In particular, the dopaminergic substance apomorphine is a central enhancer that acts in the paraventricular nucleus of the hypothalamus as a dopamine (D2) receptor agonist, induces and increases penile erection responses via disinhibition, following sexual stimulation.

Conclusions
There is a need for more research in the pharmacotherapeutic development of central and peripheral agents for safe and effective erectile dysfunction treatment.
The Multinational Men's Attitudes to Life Events and Sexuality (MALES) Study Phase II: Understanding PDE5 Inhibitor Treatment Seeking Patterns, Among Men with Erectile Dysfunction
Authors: Fisher William A. , Rosen Raymond C. , Eardley Ian , Niederberger Craig , Nadel Andrea , Kaufman Joel , Sand Michael 
Published: September 2004

ABSTRACTObjectiveThe aim of Phase II of the Men's Attitudes to Life Events and Sexuality (MALES) Study is to explore PDE5 inhibitor treatment seeking among men with erectile dysfunction (ED).MethodsPhase II of the MALES study involved 2912 men, aged 20–75 years, from 8 countries (U.S., U.K., Germany, France, Italy, Spain, Mexico, and Brazil), who reported ED. Participants were recruited from the MALES Phase I sample [1] and via booster methods (e.g., physician referral, street interception), and completed self-report questionnaires concerning the characteristics of their ED, their efforts to seek PDE5 inhibitor treatment for their sexual dysfunction, and attitudinal and referent influences that potentially affect treatment-seeking. Statistical analyses focus on identification of correlates of PDE5 inhibitor treatment seeking.ResultsPDE5 inhibitor utilization is strongly associated with ED sufferers’ assessment of the severity of their sexual dysfunction, with their belief that medication for ED is dangerous, and with their perceptions of whether physicians, other professionals, and spouses or family members are supportive of their seeking treatment. ED sufferers who evaluate their sexual dysfunction as severe, who believe that medication for ED is not dangerous, and who perceive support for treatment seeking from referent others, are more likely to utilize PDE5 inhibitor treatment.ConclusionFindings indicate that perceived ED severity, beliefs about ED medication, and referent influences are strongly correlated with utilization of PDE5 inhibitor therapy. These findings aid our understanding of factors that may incline men with ED to seek—or to avoid—PDE5 inhibitor therapy for their sexual dysfunction, and provide a basis for clinical and educational interventions to assist men with ED to seek appropriate treatment.
Update on Clinical Trials of Tadalafil Demonstrates No Increased Risk of Cardiovascular Adverse Events
Authors: Jackson Graham , Kloner Robert A. , Costigan Timothy M. , Warner Margaret R. , Emmick Jeffrey T. 
Published: September 2004

ABSTRACT

Introduction
Cardiovascular disease and erectile dysfunction (ED) share similar risk factors and often occur concomitantly. Therefore, men with ED may be at increased risk for cardiovascular adverse events.

Aim
The aim of this retrospective analysis was to evaluate the cardiovascular adverse events in clinical trials of tadalafil, an effective medication for the treatment of ED.

Methods
An integrated analysis of cardiovascular adverse events was performed on a database from 35 controlled clinical trials (placebo [N = 2,118] and tadalafil [N = 5,228]) and eight open-label trials of tadalafil (tadalafil [N = 6,939]). Some patients in controlled trials also received tadalafil in the open-label extension phase of four trials. Across all trials, the dose range of tadalafil was 2–25 mg, with the majority of patients receiving tadalafil 20 mg. This analysis represents an update of previous published results.

Results
In 35 controlled tadalafil clinical trials, the incidence of cardiovascular adverse events was low and comparable in tadalafil- and placebo-treated patients. The rate of myocardial infarction (MI) across all controlled and open-label studies was 0.33 per 100 patient-years in tadalafil-treated patients (N = 10,460, patient exposure = 5,088 patient-years). The MI rate in tadalafil-treated patients was comparable to that in placebo-treated patients (0.41 per 100 patient-years; N = 2,118; 489 patient-years), and to that in an age-standardized male population (0.6 per 100 patient-years). The cardiac mortality rate in tadalafil-treated patients across all studies (N = 10,460) was 0.12 per 100 patient-years which was not increased compared with the cardiac mortality rate of 0.26 per 100 patient-years reported in an age-standardized male population.

Conclusions
In tadalafil clinical trials, the incidence of cardiovascular adverse events in patients receiving tadalafil was low and comparable to placebo. Tadalafil did not increase the rate of MI or cardiac mortality compared with reported rates from epidemiological studies. This favorable cardiovascular safety profile for tadalafil is important, because men with ED commonly have cardiovascular disease and may seek medical therapy for ED.
Earliest Time to Onset of Action Leading to Successful Intercourse with Vardenafil Determined in an At-Home Setting: A Randomized, Double-Blind, Placebo-Controlled Trial
Authors: Montorsi Francesco , Padma-Nathan Harin , Buvat Jacques , Schwaibold Hartwig , Beneke Manfred , Ulbrich Ernst , Bandel Tiemo-Joerg , Porst Hartmut 
Published: September 2004

ABSTRACT

Introduction
Vardenafil, a potent and selective oral PDE5 inhibitor, is efficacious and generally well-tolerated in men with erectile dysfunction (ED). Of considerable interest to patients and physicians is an understanding of the time required after dosing to attain penile erection sufficient for successful sexual intercourse.

Aim
To determine the earliest time to onset of action of vardenafil 10 and 20 mg leading to successful intercourse compared to placebo in men with ED.

Methods
A prospective, randomized, double-blind, parallel-group, at-home study of 732 men with ED (mean age 55.5 years) was conducted at 64 sites in North America and Europe. Following a 4-week run-in period, patients were randomized to either vardenafil 10 (N = 237) or 20 mg (N = 248) or placebo (N = 247) to be taken on demand over 4 weeks. Using a stopwatch, patients recorded the elapsed time from dosing to attainment of an erection perceived to be adequate for penetration that led to intercourse completion. Earliest time of onset was defined as the fastest time among the first four doses for each patient. Time points from 25 to 5 minutes were tested for significance (alpha = 0.025) using a backward stepping procedure.

Results
Mean baseline erectile function domain score (13.4) indicated moderate ED. Within 25 minutes after dosing, 50%/53% of men on vardenafil 10/20 mg had at least one erection in the first four doses perceived to be sufficient for penetration with subsequent intercourse completion compared to 26% on placebo (P &lt; 0.0001). A statistically superior response to vardenafil vs. placebo was observed in these responders at all times ≥ 10 and ≥ 11 minutes (P &lt; 0.025) in the 10 and 20 mg groups, respectively. In a retrospective analysis using time intervals of ≤ 15, ≤ 20, ≤ 25 and ≤ 30 minutes between dosing and erection adequate for penetration, 75–77% of these intercourse attempts were successful (SEP3 positive) by patients receiving vardenafil 10/20 mg, compared to 45–47% of attempts by those who received placebo. Vardenafil 10/20 mg was generally well-tolerated with headache (7%/12% vs. 1%) and flushing (6%/9% vs. &lt; 1%) reported more frequently than with placebo. No patient discontinued vardenafil therapy due to adverse events.

Conclusion
In this large, at-home study, the onset of action of vardenafil with subsequent intercourse completion was recognized as early as 10 minutes after dosing.