Bringing Lived Experience to Research on Health and Homelessness: Perspectives of Researchers and Lived Experience Partners.

Improving health and healthcare for people experiencing homelessness (PEH) has become a national research priority. It is critical for research related to homelessness to be guided by input from PEH themselves. We are a group of researchers and individuals who have personally experienced homelessness collaborating on a study focused on homelessness and housing. In this Fresh Focus, we describe our partnership, lessons learned from our work together, what we have gained from our collaboration, and considerations for future homelessness research-lived experience partnerships.

68Ga-PSMA-PET screening and transponder-guided salvage radiotherapy to the prostate bed alone for biochemical recurrence following prostatectomy: interim outcomes of a phase II trial.

PURPOSE: To evaluate outcomes for men with biochemically recurrent prostate cancer who were selected for transponder-guided salvage radiotherapy (SRT) to the prostate bed alone by 68Ga-labelled prostate-specific membrane antigen positron emission tomography (68Ga-PSMA-PET). METHODS: This is a single-arm, prospective study of men with a prostate-specific antigen (PSA) level rising to 0.1-2.5 ng/mL following radical prostatectomy. Patients were staged with 68Ga-PSMA-PET and those with a negative finding, or a positive finding localised to the prostate bed, continued to SRT only to the prostate bed alone with real-time target-tracking using electromagnetic transponders. The primary endpoint was freedom from biochemical relapse (FFBR, PSA > 0.2 ng/mL from the post-radiotherapy nadir). Secondary endpoints were time to biochemical relapse, toxicity and patient-reported quality of life (QoL). RESULTS: Ninety-two patients (median PSA of 0.18 ng/ml, IQR 0.12-0.36), were screened with 68Ga-PSMA-PET and metastatic disease was found in 20 (21.7%) patients. Sixty-nine of 72 non-metastatic patients elected to proceed with SRT. At the interim (3-year) analysis, 32 (46.4%) patients (95% CI 34.3-58.8%) were FFBR. The median time to biochemical relapse was 16.1 months. The rate of FFBR was 82.4% for ISUP grade-group 2 patients. Rates of grade 2 or higher gastrointestinal and genitourinary toxicity were 0% and 15.2%, respectively. General health and disease-specific QoL remained stable. CONCLUSION: Pre-SRT 68Ga-PSMA-PET scans detect metastatic disease in a proportion of patients at low PSA levels but fail to improve FFBR. Transponder-guided SRT to the prostate bed alone is associated with a favourable toxicity profile and preserved QoL. TRIAL REGISTRATION NUMBER: ACTRN12615001183572, 03/11/2015, retrospectively registered.

Ductal variant prostate carcinoma is associated with a significantly shorter metastasis-free survival.

BACKGROUND: Ductal adenocarcinoma is an uncommon prostate cancer variant. Previous studies suggest that ductal variant histology may be associated with worse clinical outcomes, but these are difficult to interpret. To address this, we performed an international, multi-institutional study to describe the characteristics of ductal adenocarcinoma, particularly focussing on the effect of presence of ductal variant cancer on metastasis-free survival. METHODS: Patients with ductal variant histology from two institutional databases who underwent radical prostatectomies were identified and compared with an independent acinar adenocarcinoma cohort. After propensity score matching, the effect of the presence of ductal adenocarcinoma on time to biochemical recurrence, initiation of salvage therapy and the development of metastatic disease was determined. Deep whole-exome sequencing was performed for selected cases (n = 8). RESULTS: A total of 202 ductal adenocarcinoma and 2037 acinar adenocarcinoma cases were analysed. Survival analysis after matching demonstrated that patients with ductal variant histology had shorter salvage-free survival (8.1 versus 22.0 months, p = 0.03) and metastasis-free survival (6.7 versus 78.6 months, p < 0.0001). Ductal variant histology was consistently associated with RB1 loss, as well as copy number gains in TAP1, SLC4A2 and EHHADH. CONCLUSIONS: The presence of any ductal variant adenocarcinoma at the time of prostatectomy portends a worse clinical outcome than pure acinar cancers, with significantly shorter times to initiation of salvage therapies and the onset of metastatic disease. These features appear to be driven by uncoupling of chromosomal duplication from cell division, resulting in widespread copy number aberration with specific gain of genes implicated in treatment resistance.

Struggling urology trainee: a qualitative study into causes of underperformance.

BACKGROUND: Urological surgical trainees who underperform are difficult to identify, manage and require significant resources in an already stretched system relying on pro bono supervisors that often have no formal training. While there are commentaries on how to manage underperforming surgical trainees, there is a lack of data detailing the complex reasons for underperformance. It is important to understand the complexities contributing to underperformance so that improved remediation plans can be developed which can better help trainees meet expectations and succeed. METHODS: In this qualitative study, individual semi-structured interviews were conducted with key persons identified as having very high levels of background knowledge and involvement with current underperforming urological surgery trainees. Transcribed interviews were thematically analysed. RESULTS: Ten interviews were conducted, including nine urology consultants and one educational manager. Five themes were identified: underperformance is a small but profound issue; spiral of failure; the changing trainee; lack of insight and under supported supervisors and posts. CONCLUSION: Causes of underperformance in urology trainees are complex and multifactorial. Behavioural issues were considered the most likely cause, which are also the most challenging to remedy. However, in addition to trainee factors, causative factors related to supervision and training were identified. Addressing all of these issues is paramount if effective remediation of these trainees is to occur.

Transition Planning For After Polio Eradication.

The Global Polio Eradication Initiative (GPEI) has been in operation since 1988, now spends $1 billion annually, and operates through thousands of staff and millions of volunteers in dozens of countries. It has brought polio to the brink of eradication. After eradication is achieved, what should happen to the substantial assets, capabilities, and lessons of the GPEI? To answer this question, an extensive process of transition planning is underway. There is an absolute need to maintain and mainstream some of the functions, to keep the world polio-free. There is also considerable risk-and, if seized, substantial opportunity-for other health programs and priorities. And critical lessons have been learned that can be used to address other health priorities. Planning has started in the 16 countries where GPEI's footprint is the greatest and in the program's 5 core agencies. Even though poliovirus transmission has not yet been stopped globally, this planning process is gaining momentum, and some plans are taking early shape. This is a complex area of work-with difficult technical, financial, and political elements. There is no significant precedent. There is forward motion and a willingness on many sides to understand and address the risks and to explore the opportunities. Very substantial investments have been made, over 30 years, to eradicate a human pathogen from the world for the second time ever. Transition planning represents a serious intent to responsibly bring the world's largest global health effort to a close and to protect and build upon the investment in this effort, where appropriate, to benefit other national and global priorities. Further detailed technical work is now needed, supported by broad and engaged debate, for this undertaking to achieve its full potential.

[(99m)Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Multi-institutional Trial.

BACKGROUND: [(99m)Tc]Tilmanocept, a novel CD206 receptor-targeted radiopharmaceutical, was evaluated in an open-label, phase III trial to determine the false negative rate (FNR) of sentinel lymph node biopsy (SLNB) relative to the pathologic nodal status in patients with intraoral or cutaneous head and neck squamous cell carcinoma (HNSCC) undergoing tumor resection, SLNB, and planned elective neck dissection (END). Negative predictive value (NPV), overall accuracy of SLNB, and the impact of radiopharmaceutical injection timing relative to surgery were assessed. METHODS AND FINDINGS: This multicenter, non-randomized, single-arm trial (ClinicalTrials.gov identifier NCT00911326) enrolled 101 patients with T1-T4, N0, and M0 HNSCC. Patients received 50 µg [(99m)Tc]tilmanocept radiolabeled with either 0.5 mCi (same day) or 2.0 mCi (next day), followed by lymphoscintigraphy, SLNB, and END. All excised tissues were evaluated for tissue type and tumor presence. [(99m)Tc]Tilmanocept identified one or more SLNs in 81 of 83 patients (97.6 %). Of 39 patients identified with any tumor-positive nodes (SLN or non-SLN), one patient had a single tumor-positive non-SLN in whom all SLNs were tumor-negative, yielding an FNR of 2.56 %; NPV was 97.8 % and overall accuracy was 98.8 %. No significant differences were observed between same-day and next-day procedures. CONCLUSIONS: Use of receptor-targeted [(99m)Tc]tilmanocept for lymphatic mapping allows for a high rate of SLN identification in patients with intraoral and cutaneous HNSCC. SLNB employing [(99m)Tc]tilmanocept accurately predicts the pathologic nodal status of intraoral HNSCC patients with low FNR, high NPV, and high overall accuracy. The use of [(99m)Tc]tilmanocept for SLNB in select patients may be appropriate and may obviate the need to perform more extensive procedures such as END.

Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials.

BACKGROUND: Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [(99m)Tc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance. METHODS: A total of 13 centers contributed 148 patients with breast cancer. Each patient received [(99m)Tc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [(99m)Tc]tilmanocept. RESULTS: A total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [(99m)Tc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [(99m)Tc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [(99m)Tc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [(99m)Tc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [(99m)Tc]tilmanocept. CONCLUSION: [(99m)Tc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [(99m)Tc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.

Combined analysis of phase III trials evaluating [99mTc]tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically node-negative cutaneous melanoma.

BACKGROUND: [(99m)Tc]Tilmanocept is a CD206 receptor-targeted radiopharmaceutical designed for sentinel lymph node (SLN) identification. Two nearly identical nonrandomized phase III trials compared [(99m)Tc]tilmanocept to vital blue dye. METHODS: Patients received [(99m)Tc]tilmanocept and blue dye. SLNs identified intraoperatively as radioactive and/or blue were excised and histologically examined. The primary end point, concordance, was the proportion of blue nodes detected by [(99m)Tc]tilmanocept; 90 % concordance was the prespecified minimum concordance level. Reverse concordance, the proportion of radioactive nodes detected by blue dye, was also calculated. The prospective statistical plan combined the data from both trials. RESULTS: Fifteen centers contributed 154 melanoma patients who were injected with both agents and were intraoperatively evaluated. Intraoperatively, 232 of 235 blue nodes were detected by [(99m)Tc]tilmanocept, for 98.7 % concordance (p < 0.001). [(99m)Tc]Tilmanocept detected 364 nodes, for 63.7 % reverse concordance (232 of 364 nodes). [(99m)Tc]Tilmanocept detected at least one node in more patients (n = 150) than blue dye (n = 138, p = 0.002). In 135 of 138 patients with at least one blue node, all blue nodes were radioactive. Melanoma was identified in the SLNs of 22.1 % of patients; all 45 melanoma-positive SLNs were detected by [(99m)Tc]tilmanocept, whereas blue dye detected only 36 (80 %) of 45 (p = 0.004). No positive SLNs were detected exclusively by blue dye. Four of 34 node-positive patients were identified only by [(99m)Tc]tilmanocept, so 4 (2.6 %) of 154 patients were correctly staged only by [(99m)Tc]tilmanocept. No serious adverse events were attributed to [(99m)Tc]tilmanocept. CONCLUSIONS: [(99m)Tc]Tilmanocept met the prespecified concordance primary end point, identifying 98.7 % of blue nodes. It identified more SLNs in more patients, and identified more melanoma-containing nodes than blue dye.

The efficacy of Tilmanocept in sentinel lymph mode mapping and identification in breast cancer patients: a comparative review and meta-analysis of the 99mTc-labeled nanocolloid human serum albumin standard of care.

Sentinel lymph node (SLN) mapping is common, however question remains as to what the ideal imaging agent is and how such an agent might provide reliable and stable localization of SLNs. (99m)Tc-labeled nanocolloid human serum albumin (Nanocoll) is the most commonly used radio-labeled colloid in Europe and remains the standard of care (SOC). It is used in conjunction with vital blue dyes (VBDs) which relies on simple lymphatic drainage for localization. Although the exact mechanism of Nanocoll SLN localization is unknown, there is general agreement that Nanocoll exhibits the optimal size distribution and radiolabeling properties of the commercially available radiolabel colloids. [(99m)Tc]Tilmanocept is a novel radiopharmaceutical designed to address these deficiencies. Our aim was to compare [(99m)Tc]Tilmanocept to Nanocoll for SLN mapping in breast cancer. Data from the Phase III clinical trials of [(99m)Tc]Tilmanocept's concordance with VBD was compared to a meta-analysis of a review of the literature to identify a (99m)Tc albumin colloid SOC. The primary endpoints were SLN localization rate and degree of localization. Six studies were used for a meta-analysis to identify the colloid-based SOC. Five studies (6,134 patients) were used to calculate the SOC localization rate of 95.91 % (CI 0.9428-0.9754) and three studies (1,380 patients) were used for the SOC SLN degree of localization of 1.6683 (CI 1.5136-1.8230). The lower bound of the confidence interval was used for comparison to Tilmanocept. Tilmanocept data included 148 patients, and pooled analysis revealed a 99.99 % (CI 0.9977-1.0000) localization rate and degree of localization of 2.16 (CI 1.964-2.3600). Tilmanocept was superior to the Nanocoll SOC for both endpoints (P < 0.0001).

Increasing the sample size at interim for a two-sample experiment without Type I error inflation.

For the case of a one-sample experiment with known variance σ² =1, it has been shown that at interim analysis the sample size (SS) may be increased by any arbitrary amount provided: (1) The conditional power (CP) at interim is ≥ 50% and (2) there can be no decision to decrease the SS (stop the trial early). In this paper we verify this result for the case of a two-sample experiment with proportional SS in the treatment groups and an arbitrary common variance. Numerous authors have presented the formula for the CP at interim for a two-sample test with equal SS in the treatment groups and an arbitrary common variance, for both the one- and two-sided hypothesis tests. In this paper we derive the corresponding formula for the case of unequal, but proportional SS in the treatment groups for both one-sided superiority and two-sided hypothesis tests. Finally, we present an SAS macro for doing this calculation and provide a worked out hypothetical example. In discussion we note that this type of trial design trades the ability to stop early (for lack of efficacy) for the elimination of the Type I error penalty. The loss of early stopping requires that such a design employs a data monitoring committee, blinding of the sponsor to the interim calculations, and pre-planning of how much and under what conditions to increase the SS and that this all be formally written into an interim analysis plan before the start of the study.

Static and dynamic novelty detection methods for jet engine health monitoring.

Novelty detection requires models of normality to be learnt from training data known to be normal. The first model considered in this paper is a static model trained to detect novel events associated with changes in the vibration spectra recorded from a jet engine. We describe how the distribution of energy across the harmonics of a rotating shaft can be learnt by a support vector machine model of normality. The second model is a dynamic model partially learnt from data using an expectation-maximization-based method. This model uses a Kalman filter to fuse performance data in order to characterize normal engine behaviour. Deviations from normal operation are detected using the normalized innovations squared from the Kalman filter.

Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial.

BACKGROUND: Venous leg ulcers are a major cause of morbidity, economic loss, and decreased quality of life in affected patients. Recently, biomaterials derived from natural tissue sources have been used to stimulate wound closure. One such biomaterial obtained from porcine small-intestine submucosa (SIS) has shown promise as an effective treatment to manage full-thickness wounds. Our objective was to compare the effectiveness of SIS wound matrix with compression vs compression alone in healing chronic leg ulcers within 12 weeks. METHODS: This was a prospective, randomized, controlled multicenter trial. Patients were 120 patients with at least 1 chronic leg ulcer. Patients were randomly assigned to receive either weekly topical treatment of SIS plus compression therapy (n = 62) or compression therapy alone (n = 58). Ulcer size was determined at enrollment and weekly throughout the treatment. Healing was assessed weekly for up to 12 weeks. Recurrence after 6 months was recorded. The primary outcome measure was the proportion of ulcers healed in each group at 12 weeks. RESULTS: After 12 weeks of treatment, 55% of the wounds in the SIS group were healed, as compared with 34% in the standard-care group (P = .0196). None of the healed patients treated with SIS wound matrix and seen for the 6-month follow-up experienced ulcer recurrence. CONCLUSIONS: The SIS wound matrix, as an adjunct therapy, significantly improves healing of chronic leg ulcers over compression therapy alone.

Laboratory evaluation of oil spill bioremediation products in salt and freshwater systems.

Ten oil spill bioremediation products were tested in the laboratory for their ability to enhance biodegradation of weathered Alaskan North Slope crude oil in both freshwater and saltwater media. The products included nutrients to stimulate inoculated microorganisms, nutrients plus an oil-degrading inoculum, nutrients plus compounds intended to stimulate oil-degrading activity, or other compounds intended to enhance microbial activity. The product tests were undertaken to evaluate significant modifications in the existing official United States Environmental Protection Agency (EPA) protocol used for qualifying commercial bioremediation agents for use in oil spills. The EPA protocol was modified to include defined formulas for the exposure waters (freshwater, saltwater), a positive control using a known inoculum and nutrients, two negative controls (one sterile, the other inoculated but nutrient-limited), and simplified oil chemical analysis. Three analysts conducted the product test independently in each type of exposure water in round-robin fashion. Statistical tests were performed on analyst variability, reproducibility, and repeatability, and the performance of the various products was quantified in both exposure media. Analysis of variance showed that the analyst error at each time-point was highly significant (P values ranged from 0.0001 to 0.008, depending on water type and oil fraction). In the saltwater tests, six products demonstrated various degrees of biodegradative activity against the alkane fraction of the crude oil and three degraded the aromatic hydrocarbons by >10%. In the freshwater tests, eight products caused >20% loss of alkane hydrocarbons, of which five degraded the alkanes by >50%. Only four products were able to degrade polycyclic aromatic hydrocarbons (PAHs) by >20%, one of which caused 88% removal. However, when the variability of the analysts was taken into consideration, only one of the ten products was found to yield significant percent removals of the PAH fraction and only in freshwater. Viable microorganism population analysis (most-probable-number method) was also performed on every sample by each operator to measure the changes in aromatic and alkane hydrocarbon-degrading organism numbers. In general, little evidence of significant growth of either alkane- or PAH-degraders occurred among any of the ten products in either the saltwater or freshwater testing.

Trade-based carbon sequestration accounting.

This article describes and illustrates an accounting method to assess and compare "early" carbon sequestration investments and trades on the basis of the number of standardized CO2 emission offset credits they will provide. The "gold standard" for such credits is assumed to be a relatively riskless credit based on a CO2 emission reduction that provides offsets against CO2 emissions on a one-for-one basis. The number of credits associated with carbon sequestration needs to account for time, risk, durability, permanence, additionality, and other factors that future trade regulators will most certainly use to assign "official" credits to sequestration projects. The method that is presented here uses established principles of natural resource accounting and conventional rules of asset valuation to "score" projects. A review of 20 "early" voluntary United States based CO2 offset trades that involve carbon sequestration reveals that the assumptions that buyers, sellers, brokers, and traders are using to characterize the economic potential of their investments and trades vary enormously. The article develops a "universal carbon sequestration credit scoring equation" and uses two of these trades to illustrate the sensitivity of trade outcomes to various assumptions about how future trade auditors are likely to "score" carbon sequestration projects in terms of their "equivalency" with CO2 emission reductions. The article emphasizes the importance of using a standard credit scoring method that accounts for time and risk to assess and compare even unofficial prototype carbon sequestration trades. The scoring method illustrated in this article is a tool that can protect the integrity of carbon sequestration credit trading and can assist buyers and sellers in evaluating the real economic potential of prospective trades.

Development of indicators to assess economic vulnerabilities to changes in ecosystem services: case study of counties in Maryland, USA.

We develop indicators showing the relative environmental burdens that human activities place on locales for a given level of economic benefits. The main purpose is to develop tools that allow us to examine the potential vulnerabilities within economies to changes in resource conditions. The indicators of pollution emission or resource consumption per job can be used to identify potential challenges to resource and industry managers and to compare areas in terms of their ability to adapt to change. For example, if a large number of area jobs are dependent on abundant water, this indicates a vulnerability to a reduction in water availability for industrial use. We develop a case study for 23 counties and 1 city in Maryland to examine the usefulness and limitations of the indicators. Our case study demonstrates that the indicators provide an informative view into patterns of local economic activity and use of an area's environmental goods and services. In contrast to patterns for total environmental burdens (e.g., total SO2 emissions) that are typically reported, the rates of environmental burden per job are not simply correlated with high or low economic output. Thus, the indicators represent distinct patterns of environmental burdens per job that reflect reliance on environmental services. The indicators have some limitations when used at this fine scale because they can misrepresent conditions in counties in which economic sectors are dominated by one or a few businesses. For this reason, the indicators are best used as a regional screening tool.

Six-month comparison of powered versus manual toothbrushing for safety and efficacy in the absence of professional instruction in mechanical plaque control.

BACKGROUND: Reports suggest powered toothbrushing may provide some clinical benefit over manual tooth-brushing, but most studies have been of short duration with subjects trained in toothbrush use. The aim was to determine if the oscillating-rotating powered brush (PB) could safely provide clinical benefits over and above a manual brush (M) in subjects with no formal instruction or experience in powered brush use. METHODS: This 6-month, single-masked, parallel design, randomized clinical trial compared the PB with an American Dental Association (ADA)-accepted soft-bristle manual brush in a non-flossing gingivitis population (n = 157). Subjects were given written instructions but no demonstration on toothbrush use at baseline. Efficacy was assessed by changes in gingival inflammation, plaque, calculus, and stain, while changes in clinical attachment levels and recession measurements provided safety data. A prophylaxis was provided after baseline assessment. The 6-month plaque index (PI) was recorded immediately post-brushing after covert timing of the subjects, and correlation analyses were run to assess the relationship of brushing time to PI. Paired t tests, analysis of variance (ANOVA), and analysis of covariance (ANCOVA) were used to assess within and between treatment group differences for PB (n = 76) versus M groups (n = 81). RESULTS: Measures of inflammation showed a statistically significant drop for both brushes at 3 and 6 months. Mean overnight full-mouth PI scores were significantly lower at 3 months for the PB (1.57) compared to the M group (1.80), P = 0.0013. Immediate post-brushing PI at 6 months was also significantly lower for the PB (1.10) versus M (1.39) (P= 0.0025). There was an overall negative correlation for PI and brushing time (r = -0.377, P= 0.0001). Mean calculus index (CI) scores were lower for the PB at 3 (P= 0.0304) and 6 months (P = 0.0078), while no significant differences in stain were observable. Clinical attachment level and recession measurements showed no significant between-group changes from baseline for either brush on canine teeth or on teeth with recession at baseline. CONCLUSION: The oscillating-rotating toothbrush safely provides clinical benefits in plaque and calculus reduction over a manual brush even in subjects with no formal oral hygiene instruction.

A clinical investigation into the effect of toothbrush wear on efficacy.

It is generally recommended that toothbrushes should be replaced after three-months' use in order to maintain efficacy. This clinical investigation employed a single-use, cross-over study and a three-month parallel-group study to investigate the effect of toothbrush wear on plaque and gingival health. Toothbrushes were artificially worn using a laboratory wear machine to simulate three months of clinical toothbrush use. Results from the single-use study showed that both the new and the worn toothbrushes significantly reduced whole mouth, marginal and approximal plaque scores from pre- to post-brushing (p < 0.0001). The new brush was, however, significantly more effective than the worn brush, demonstrating 13.4%, 11.0%, and 17.0% greater plaque reduction for whole mouth, marginal and approximal sites, respectively (p < 0.0001). Results from the three-month study confirmed this finding, with significant differences in plaque reduction (p < 0.0001) between the new and worn toothbrushes at 6 and 12 weeks for all sites. A significant difference (p < 0.0001) between the groups was also found for mean whole mouth gingivitis scores; this difference favoring the new brush at both 6 and 12 weeks. Examination of hard and soft oral tissues revealed no significant difference between the new and the worn brushes with respect to safety. It is concluded that a worn toothbrush is less effective than a new toothbrush for plaque removal and control of gingivitis.

A clinical study of plaque removal with an advanced rechargeable power toothbrush and a battery-operated device.

PURPOSE: To compare the safety and efficacy of two recently introduced modern power toothbrushes with different characteristics. MATERIALS AND METHODS: This was a single-blind, randomized, crossover study which compared the ability of two power toothbrushes to remove plaque during a 2-minute brushing period. The two brushes were the Braun Oral-B 3D Excel (D17), a rechargeable toothbrush with an oscillating/rotating/pulsating action and the Colgate Actibrush, a battery-operated device with an oscillating/rotating action. Seventy-four healthy subjects from a general population who met the inclusion/exclusion criteria used the two brushes on alternate days for a period of familiarization before returning to the test facility. At this visit, subjects with a whole mouth mean Proximal/Marginal Plaque Index of > or = 2.20 after 23-25 hours of no oral hygiene were randomly assigned to one of two treatment sequences, D17/Actibrush and Actibrush/D17, balanced for age and gender. Subjects brushed with their assigned toothbrush after which post-brushing plaque scores were recorded. After a 2-week washout phase subjects returned to the test facility and brushed with the alternate toothbrush as described. Data from the two visits were pooled, after which plaque removal efficacies were compared. Change from prebrushing treatment means were compared using ANOVA with models appropriate for the crossover design. RESULTS: Both toothbrushes were found to be safe and both significantly reduced plaque levels (P < or = 0.0001), but the D17 was significantly more effective than the Actibrush for the whole mouth and for approximal sites. Plaque reductions for the D17 were 46.5%, 55.2% and 42.9% for whole mouth, marginal and approximal sites, respectively while reductions for the Actibrush for the whole mouth, marginal, and approximal sites, were 41.5%, 52.5% and 36.8% respectively. It is concluded that the Braun Oral-B D17 may offer advantages in terms of plaque removal over the battery-powered Actibrush, particularly at hard to reach approximal sites.