Clinical research leadership-"A blueprint".

The principles of leadership in academic research, reflect those of life in general and differ only by circumstance. A great leader is one who inspires and energizes, motivating and empowering the whole team to achieve. They articulate a vision, establish direction, clarify the big picture and set clear strategies in a positive culture. A great leader needs to align and connect people by fostering excellent communication channels, gaining commitment and building teams and coalitions.

Periodontal diagnosis in the context of the 2017 classification system of periodontal diseases and conditions: presentation of a patient with periodontitis localised to the molar teeth.

The objective of this case report is to illustrate the diagnosis and classification of periodontitis, according to the 2017 classification system, as recommended in the British Society of Periodontology (BSP) implementation plan. A 37-year-old female was diagnosed with periodontitis (molar-incisor pattern), stage III, grade C, currently unstable. Several issues pertinent to the diagnosis of localised forms of periodontitis in young patients are discussed in relation to the current and previous classification systems. Periodontitis can be limited to a few sites and this case highlights the importance of the careful application of the basic periodontal examination (BPE).

Periodontal diagnosis in the context of the 2017 classification system of periodontal diseases and conditions: Presentation of a middle-aged patient with localised periodontitis.

The objective of this case report is to illustrate the diagnosis and classification of periodontitis according to the 2017 classification system as recommended in the British Society of Periodontology (BSP) implementation plan. We describe a case of a patient who was diagnosed with 'localised periodontitis; stage II, grade B; currently unstable'. The present case report presents an example for the application of the new classification system and illustrates how the new classification system captures disease severity, extent and disease susceptibility by staging and grading periodontitis.

Periodontal diagnosis in the context of the 2017 classification system of periodontal diseases and conditions - implementation in clinical practice.

The 2017 World Workshop Classification system for periodontal and peri-implant diseases and conditions was developed in order to accommodate advances in knowledge derived from both biological and clinical research, that have emerged since the 1999 International Classification of Periodontal Diseases. Importantly, it defines clinical health for the first time, and distinguishes an intact and a reduced periodontium throughout. The term 'aggressive periodontitis' was removed, creating a staging and grading system for periodontitis that is based primarily upon attachment and bone loss and classifies the disease into four stages based on severity (I, II, III or IV) and three grades based on disease susceptibility (A, B or C). The British Society of Periodontology (BSP) convened an implementation group to develop guidance on how the new classification system should be implemented in clinical practice. A particular focus was to describe how the new classification system integrates with established diagnostic parameters and pathways, such as the basic periodontal examination (BPE). This implementation plan focuses on clinical practice; for research, readers are advised to follow the international classification system. In this paper we describe a diagnostic pathway for plaque-induced periodontal diseases that is consistent with established guidance and accommodates the novel 2017 classification system, as recommended by the BSP implementation group. Subsequent case reports will provide examples of the application of this guidance in clinical practice.

Periodontal diagnosis in the context of the BSP implementation plan for the 2017 classification system of periodontal diseases and conditions: presentation of a pair of young siblings with periodontitis.

The objective of this case report is to illustrate the diagnosis and classification of periodontitis according to the 2017 classification system as recommended in the British Society of Periodontology (BSP) implementation plan. We describe two cases in the form of a pair of siblings, who developed periodontitis very early in life. A 19-year-old female was diagnosed with 'generalised periodontitis; stage III/grade C; currently unstable'. Her 14-year-old sister was diagnosed with 'localised periodontitis; stage II, grade C; currently unstable'. The present case report presents an example for the application of the new classification system and illustrates the importance of a periodontal check for children and adolescents and/or their relatives.

Prevalence of gingival recession and study of associated related factors in young UK adults.

OBJECTIVES: To determine the prevalence of gingival recession (GR) and associations with dentine hypersensitivity (DH), erosive toothwear (BEWE), gingival bleeding (BOP) and periodontal pocketing (PPD) in young European adults. MATERIALS AND METHODS: This is a secondary analysis using data collected from 350 UK participants enrolled in a European cross sectional study of 3187 young adults. GR, BOP, PPD, DH (participant and clinician assessment) and BEWE were recorded. A questionnaire assessed demographics, oral hygiene and lifestyle habits. RESULTS: 349 participants completed the study. GR, BOP and PPD showed the same pattern of distribution, prevalence increasing from incisors to molars in upper and lower arches for buccal and palatal scores. Every participant exhibited recession affecting at least 1 tooth, 42% having a maximum recession of 4-8 mm. There was a significant and linear association demonstrating an increase in maximum recession with age. DH and BEWE produced a similar pattern to buccal periodontal indices, the premolars being most affected. Maximum recession correlated significantly with maximum DH (participant and Schiff), PPD, BOP, BEWE (scores of 2/3), BMI (≥25 kg/m2) and unsystematic brushing motion. 94% of the study population exhibited some BOP at one or more sites. 5% of the population had periodontal pocketing ≥4 mm, 46% had DH and 80% BEWE 2/3. CONCLUSION: Widespread recession and gingivitis with minimal periodontal disease was observed. Every participant exhibited at least one tooth with recession. Many teeth did not exhibit DH despite prevalent recession and severe erosive toothwear. Recession correlates to a number of oral and lifestyle variables. CLINICAL SIGNIFICANCE: Recession in young adults is multifactorial and highly prevalent. It can result in DH and consequential increase in demand for treatment relating to both pain and aesthetics. Further research is needed to understand the underlying aetiology to prevent recession occurring.

A clinical study to measure anti-erosion properties of a stabilized stannous fluoride dentifrice relative to a sodium fluoride/triclosan dentifrice.

OBJECTIVE: To compare the enamel protection efficacy of a stabilized stannous fluoride (SnF2 ) dentifrice to a sodium fluoride (NaF)/triclosan dentifrice following acidic erosive challenge. METHODS: In this in situ, randomized, controlled, double-blind, two-treatment, four-period crossover clinical trial, subjects wore an appliance fitted with human enamel samples 6 h day-1 during each 15-day treatment period. Twice each treatment day they swished with their assigned dentifrice slurry: 0.454% SnF2 /0.077% NaF or 0.32% NaF/0.3% triclosan. After each treatment and two other times daily, subjects swished with 250 ml of orange juice over a 10-min period (acidic erosive challenge). Enamel samples were measured for tooth surface loss using contact profilometry at baseline and days 10 and 15. RESULTS: Thirty-six subjects (mean age 44.8 years, range 23-65 years) were randomized to treatment; 33 subjects completed the final study visit. There were no statistically significant baseline differences (P > 0.44) in the specimen surfaces of the two dentifrice treatment groups via profilometry. At day 10, the SnF2 dentifrice provided a statistically significant (P < 0.0001) reduction in enamel loss by 67% versus the NaF/triclosan dentifrice with estimated medians of 1.22 and 3.68 µm, respectively. At day 15, the SnF2 dentifrice again provided a significantly greater benefit (P < 0.0001) against tooth surface loss versus the NaF/triclosan dentifrice, with 68% less erosion, and estimated medians of 1.60 and 5.03 µm, respectively. Both dentifrices were well tolerated. CONCLUSION: A stabilized SnF2 dentifrice provided superior protection against the initiation and progression of tooth enamel surface loss in situ after erosive challenge compared to a NaF/triclosan dentifrice.

A randomised clinical in situ study to evaluate the effects of novel low abrasivity anti-sensitivity dentifrices on dentine wear.

OBJECTIVES: To compare the abrasive wear on human dentine in an in situ model associated with use of an experimental low abrasivity anti-sensitivity dentifrice containing 1% alumina and 5% sodium tripolyphosphate (STP) with an experimental ultra-low abrasivity non-alumina 5% STP dentifrice, a higher abrasivity daily-use whitening dentifrice, and water as controls. METHODS: This was a single-centre, single-blind, randomised, split-mouth, four-treatment, two-period, crossover in situ study in 29 healthy subjects. Subjects wore bilateral lower buccal appliances, each fitted with four dentine specimens. Study treatments were applied ex vivo (three times daily). Dentine loss was measured by non-contact profilometry after 5, 10 and 15days' treatment. RESULTS: All 29 subjects were included in the efficacy analysis. Significantly less dentine loss was associated with brushing with the low and ultra-low abrasivity dentifrices than with the higher abrasivity dentifrice at all timepoints (p<0.01). Brushing with ultra-low abrasivity dentifrice or water resulted in statistically significantly less dentine loss compared with brushing with the low abrasivity dentifrice at all timepoints (p<0.05). Dentine loss after brushing with ultra-low abrasivity dentifrice was not significantly different from brushing with water. CONCLUSIONS: The degree of dentine loss observed in this in situ model reflected the abrasivity of the study dentifrices. Brushing with low or ultra-low abrasivity STP-containing anti-sensitivity dentifrices resulted in significantly less dentine loss (equating to dentine wear) than with a higher abrasivity daily-use whitening dentifrice.

Erosion protection benefits of stabilized SnF2 dentifrice versus an arginine-sodium monofluorophosphate dentifrice: results from in vitro and in situ clinical studies.

OBJECTIVES: The aim of these investigations was to assess the ability of two fluoride dentifrices to protect against the initiation and progression of dental erosion using a predictive in vitro erosion cycling model and a human in situ erosion prevention clinical trial for verification of effectiveness. MATERIALS AND METHODS: A stabilized stannous fluoride (SnF2) dentifrice (0.454 % SnF2 + 0.077 % sodium fluoride [NaF]; total F = 1450 ppm F) [dentifrice A] and a sodium monofluorophosphate [SMFP]/arginine dentifrice (1.1 % SMFP + 1.5 % arginine; total F = 1450 ppm F) [dentifrice B] were tested in a 5-day in vitro erosion cycling model and a 10-day randomized, controlled, double-blind, two-treatment, four-period crossover in situ clinical trial. In each study, human enamel specimens were exposed to repetitive product treatments using a standardized dilution of test products followed by erosive acid challenges in a systematic fashion. RESULTS: Both studies demonstrated statistically significant differences between the two products, with dentifrice A providing significantly better enamel protection in each study. In vitro, dentifrice A provided a 75.8 % benefit over dentifrice B (p < 0.05, ANOVA), while after 10 days in the in situ model, dentifrice A provided 93.9 % greater protection versus dentifrice B (p < 0.0001, general linear mixed model). CONCLUSION: These results support the superiority of stabilized SnF2 dentifrices for protecting human teeth against the initiation and progression of dental erosion. CLINICAL RELEVANCE: Stabilized SnF2 dentifrices may provide more significant benefits to consumers than conventional fluoride dentifrices.

A Randomised trial to investigate the erosive effect of hot drinks.

Research on dental erosion has largely been undertaken at room temperature despite fruit juice drinks often being consumed at elevated temperatures in the United Kingdom, notably during periods of convalesce. The aim of the study was to evaluate the erosive potential of two fruit juices containing acidic non-alcoholic drinks at elevated temperatures in situ on human enamel after 5, 10 and 15 days. A commercially available conventional apple and blackcurrant fruit juice drink was compared to a blackcurrant juice drink modified to have low erosive potential, and mineral water consumed at approximately 59 °C. Twenty-one healthy volunteers aged 18 or over participated in a single-centre, single-blind (blinded to the investigator), three-treatment crossover study. Subjects were randomised to a treatment sequence using a Latin square design. Subjects wore upper removable appliances containing one human enamel specimen from 9 am to 5 pm for 15 days for each beverage. Measurements of enamel loss were recorded after 5, 10 and 15 days by contact surface profilometry. The low erosive blackcurrant drink caused significantly less enamel loss (P < 0·05) than the commercially available conventional apple and blackcurrant fruit juice drink and was not statistically significantly different to mineral water at any of the time points in the study. Consuming the modified low erosive blackcurrant drink at an elevated temperature resulted in negligible enamel loss in situ, consistent with room temperature findings.

Periodontitis: a potential risk factor for Alzheimer's disease.

The role of periodontitis as a risk factor for multiple systemic diseases is widely accepted and there is growing evidence of an association between periodontitis and sporadic late onset Alzheimer's disease (SLOAD). Recent epidemiologic, microbiologic and inflammatory findings strengthen this association, indicating that periodontal pathogens are possible contributors to neural inflammation and SLOAD. The aim of this article is to present contemporary evidence of this association.

Prevalence of tooth wear on buccal and lingual surfaces and possible risk factors in young European adults.

To assess the prevalence of tooth wear on buccal/facial and lingual/palatal tooth surfaces and identify related risk factors in a sample of young European adults, aged 18-35 years. Calibrated and trained examiners measured tooth wear, using the basic erosive wear examination (BEWE) on in 3187 patients in seven European countries and assessed the impact of risk factors with a previously validated questionnaire. Each individual was characterized by the highest BEWE score recorded for any scoreable surface. Bivariate analyses examined the proportion of participants who scored 2 or 3 in relation to a range of demographic, dietary and oral care variables. The highest tooth wear BEWE score was 0 for 1368 patients (42.9%), 1 for 883 (27.7%), 2 for 831 (26.1%) and 3 for 105 (3.3%). There were large differences between different countries with the highest levels of tooth wear observed in the UK. Important risk factors for tooth wear included heartburn or acid reflux, repeated vomiting, residence in rural areas, electric tooth brushing and snoring. We found no evidence that waiting after breakfast before tooth brushing has any effect on the degree of tooth wear (p=0.088). Fresh fruit and juice intake was positively associated with tooth wear. In this adult sample 29% had signs of tooth wear making it a common presenting feature in European adults.

The role of toothpaste in the aetiology and treatment of dentine hypersensitivity.

Dentine hypersensitivity (DH) is a common, painful dental condition with a multi-factorial aetiology. The hydrodynamic mechanism theory to explain dentine sensitivity also appears to fit DH: lesions exhibiting large numbers of open dentinal tubules at the surface and patent to the pulp. By definition, DH can only occur when dentine becomes exposed (lesion localisation) and tubules opened (lesion initiation), thus permitting increased fluid flow in tubules on stimulation. Erosion, particularly from dietary acids appears to play a dominant role in both processes. Toothbrushing with most toothpaste products alone cause clinically insignificant wear of enamel but are additive, even synergistic, to erosive enamel loss. Additionally, toothbrushing with toothpaste is implicated in 'healthy' gingival recession. Toothbrushing with most toothpastes removes the smear layer to expose tubules and again can exacerbate erosive loss of dentine. These findings thereby implicate toothbrushing with toothpaste in the aetiology of DH. Management of the condition should have secondary prevention at the core of treatment and therefore, must consider first and foremost the aetiology. Fluoride toothpaste at present appears to provide little primary or secondary preventive benefits to DH; additional ingredients can provide therapeutic benefits. Potassium-based products to block pulpal nerve response have caused much debate and are considered by many as unproven, which should not translate to ineffective. Several toothpaste technologies formulated to block tubules are from studies in vitro, in situ and controlled clinical trials considered proven for the treatment of DH.

In situ randomised trial to investigate the occluding properties of two desensitising toothpastes on dentine after subsequent acid challenge.

OBJECTIVES: The aim of the study was to determine in situ the relative abilities of two desensitising toothpastes to occlude dentinal tubules with or without acid challenge. MATERIALS AND METHODS: The study design was a single centre, randomised, split mouth crossover model examining four treatments over two periods. The primary outcome was the degree of occlusion proffered by two desensitising toothpastes [Sensodyne® Rapid Relief (8% strontium acetate, 1040 ppm sodium fluoride) and Colgate® Sensitive Pro-ReliefTM daily (8% arginine, 1450 ppm sodium monofluorophosphate)], a standard toothpaste (1450 ppm sodium fluoride) and water, after acid challenge. Healthy adult volunteers wore bi-lateral lower buccal appliances each with two dentine sections, receiving two treatments per study period. Samples were brushed twice a day with treatment, with two additional 3-min extra-oral acidic challenges applied ex vivo on days 3 and 4. A secondary outcome was the degree of occlusion attained in the absence of acid challenge. Examiners blinded to the study assessed occlusion by visual score of post-treatment scanning electron microscope images. RESULTS: All 28 participants completed the study. In the absence of acid challenge, occlusion scores for both desensitising toothpastes were similar and significantly better than control scores (p < 0.02). After acid challenge both desensitising toothpastes occluded more effectively than controls; however, occlusion scores for the strontium acetate paste were significantly greater than those of the arginine paste (p < 0.02). CONCLUSIONS: The occluding properties of the strontium acetate toothpaste were significantly more robust after acid challenge than those of the arginine toothpaste. CLINICAL RELEVANCE: Patients with hypersensitivity, regularly imbibing dietary acidic drinks, should be advised that Sensodyne® Rapid Relief provides robust tubule occlusion despite repeated acidic challenges.

Dentin hypersensitivity: pain mechanisms and aetiology of exposed cervical dentin.

OBJECTIVES: The paper's aim is to review dentin hypersensitivity (DHS), discussing pain mechanisms and aetiology. MATERIALS AND METHODS: Literature was reviewed using search engines with MESH terms, DH pain mechanisms and aetiology (including abrasion, erosion and periodontal disease). RESULTS: The many hypotheses proposed for DHS attest to our lack of knowledge in understanding neurophysiologic mechanisms, the most widely accepted being the hydrodynamic theory. Dentin tubules must be patent from the oral environment to the pulp. Dentin exposure, usually at the cervical margin, is due to a variety of processes involving gingival recession or loss of enamel, predisposing factors being periodontal disease and treatment, limited alveolar bone, thin biotype, erosion and abrasion. CONCLUSIONS: The current pain mechanism of DHS is thought to be the hydrodynamic theory. The initiation and progression of DHS are influenced by characteristics of the teeth and periodontium as well as the oral environment and external influences. Risk factors are numerous often acting synergistically and always influenced by individual susceptibility. CLINICAL RELEVANCE: Whilst the pain mechanism of DHS is not well understood, clinicians need to be mindful of the aetiology and risk factors in order to manage patients' pain and expectations and prevent further dentin exposure with subsequent sensitivity.

In situ randomised trial investigating abrasive effects of two desensitising toothpastes on dentine with acidic challenge prior to brushing.

OBJECTIVES: To determine if brushing dentine with 2 moderate RDA desensitising toothpastes, results in a significant dentine wear difference and whether this difference continues to be relevant when preceded with an erosive challenge. METHODS: An in situ, single centre, single blind, randomised, split mouth study, evaluated the difference in abrasion of 2 toothpastes (SFM - Sensodyne Fresh Mint(®) RDA 70; CPHM - Crest Pro-Health Clean Mint(®) RDA 120) in 28 healthy volunteers. Two toothpaste treatments were administered 3×/day, for each of the two 15 day periods, subjects wearing bi-lateral, lower buccal appliances each with 4 dentine sections. A 2 min extra-oral acidic challenge preceded toothbrushing for 2 study arms. Contact profilometry measured samples at baseline, days 5, 10 and 15. RESULTS: Brushing with SFM was significantly less abrasive than brushing with CPHM at all time points, with or without a preceding acidic challenge (p<0.0001). The additional dentine loss arising from the erosive challenge prior to brushing with each paste was linear with time and independent of abrasive effect. CONCLUSIONS: The desensiting toothpastes' RDA, directly related to dentine loss with toothbrushing. An acidic challenge prior to brushing did not negate the benefits of reduced wear from the lower RDA paste compared to the higher RDA paste. When brushing eroded dentine, the additional wear appeared independent of abrasive effect. Dentine hypersensitivity sufferers should be recommended to use a low-moderate RDA toothpaste, not to brush more than 2×/day and not immediately following an acidic challenge.

Randomized in situ clinical study comparing the ability of two new desensitizing toothpaste technologies to occlude patent dentin tubules.

OBJECTIVE: To compare the ability of two new desensitizing toothpaste technologies (one a 5% NovaMin-based toothpaste and the other an 8% arginine-based toothpaste) to occlude patent dentin tubules in a clinical environment relative to a negative control of water and a control toothpaste after four days of twice-daily brushing and dietary acidic challenges. METHODS: The study design was a single-center, single-blind, randomized, split-mouth, four-treatment, two-period, crossover, in situ clinical study. Healthy subjects wore two lower intra-oral appliances, retaining four dentin samples for four treatment days for each period of the clinical study. Samples were brushed twice daily with a test product (days 1-4), with an additional acidic challenge introduced on two selective days. Scanning electron microscopy (SEM) images were taken of the dentin surface, and dentinal tubule occlusion assessed using a categorical scale. RESULTS: The results demonstrated that the 5% NovaMin toothpaste was statistically superior at occluding patent dentin tubules compared to water (p = 0.009) and the control toothpaste (p = 0.02) at day 4. In contrast, the treatment effect resulting from the 8% arginine toothpaste did not demonstrate the same degree of occlusive propensity, showing no significant difference to the water and control toothpaste at the day 4 time point. CONCLUSION: Application of the 5% NovaMin toothpaste to dentin showed better dentin tubule occlusion and retention abilities in an oral environment under dietary acid challenge conditions, more so than the 8% arginine toothpaste technology. Given modern dietary habits and practices, these results highlight differences in the acid resistance properties of occlusion technologies, and a potential impact on clinical performance.

In vitro and in situ erosion models for evaluating tooth substance loss.

Because of the difficulties in measuring erosion in vivo, a number of in vitro and in situ models have been developed and validated. These models are flexible and informative, allowing single as well as multiple variables to be examined under specific conditions using accurate measurement techniques over defined timelines, thus yielding useful data without harmful effects on individuals. This information, together with clinical findings, is essential for clinicians advising susceptible patients appropriately regarding the management of their condition. Little guidance is available, however, on the standardisation of in vitro and in situ protocols for erosive tooth wear studies, so it is difficult to make meaningful comparisons between investigations as experimental variables differ widely from study to study. The aim of this review was to collate the available data on models designed to assess erosive challenges which are severe enough to cause tissue loss as opposed to just softening of the surface structure. The different types of models, with their merits and pitfalls, are documented. Test substrates, disinfecting regimens and ethical considerations are discussed. The aims of this paper are to give guidance to the researcher on evidence-based in vitro and in situ erosive tooth wear methodology and to suggest best practice given current knowledge.

The erosive effects of saliva following chewing gum on enamel and dentine: an ex vivo study.

OBJECTIVES: The primary objective was to determine the erosive effect of expectorated saliva, following chewing acidic gum, on enamel and dentine samples, using a non-acidic gum as a negative control. Secondary objectives were to determine the effect of brushing enamel and dentine samples and the effect of individual saliva pH and buffering. DESIGN: A single-centre, single-blind, placebo-controlled, two-way crossover study. SETTING: A clinical trial, involving healthy participants, undertaken at Bristol Dental School and Hospital. METHODS: Eight healthy participants expectorated saliva onto prepared enamel and dentine samples while chewing gum (strawberry flavoured acidic gum [active] or peppermint flavoured non-acidic gum [control]). Half of the enamel and dentine samples were brushed before measurement by contact profilometry. MAIN OUTCOME MEASURES: Mean enamel and dentine erosion, with and without brushing and the relationship to salivary buffering.Results At 10 days, mean depth of surface loss from dentine samples (95% CI), following chewing of acid-containing gum and subsequent brushing, was -11.34 µm (2.22 µm) and from un-brushed dentine samples was -11.02 µm (1.71 µm). No significant erosion was noted for other groups. CONCLUSIONS: Frequent chewers of acid-containing gums are susceptible to dentine erosion even in the presence of good salivary buffering. Enamel erosion was insignificant within the time constraints of the present study but warrants further investigation.

Clinical study investigating abrasive effects of three toothpastes and water in an in situ model.

OBJECTIVES: This in situ study compared the abrasive effect of repeated brushings (over 10 days) of a low relative abrasive dentine (RDA) toothpaste with moderate and high relative abrasive dentine (RDA) toothpastes, on human dentine in situ. MATERIALS AND METHODS: The study design was single centre, single blind, randomized, split mouth, two period, four-treatment cross-over, in situ study in 20 healthy subjects. Subjects wore bi-lateral lower buccal appliances each fitted with four dentine sections with treatment applied with a power toothbrush, during each 10 day study period. Samples were measured at baseline, day 5 and day 10 by contact profilometry, and baseline and day 10 with non-contact profilometry. RESULTS: Nineteen subjects were included in the efficacy analysis. Results as measured by contact and non-contact profilometry from brushing with the moderate RDA paste and high RDA paste showed significantly (p<0.0001) more abrasion to dentine than brushing with the low RDA paste or water after 10 days. Dentine loss following tooth brushing with the low RDA paste was not significantly different from brushing with water, after 10 days. CONCLUSIONS: The methodology successfully showed clear differentiation between the amount of dentine lost following toothbrushing with the low RDA paste compared to the moderate or high RDA pastes. Dentine loss following brushing with the low RDA paste showed a comparable degree of abrasion to brushing with water.