Compliance with Specialist Referral for Increased Cancer Risk in Low-Resource Settings: In-Person vs. Telehealth Options.

Efforts are underway to improve the accuracy of non-specialist screening for oral cancer (OC) risk, yet better screening will only translate into improved outcomes if at-risk individuals comply with specialist referral. Most individuals from low-resource, minority, and underserved (LRMU) populations fail to complete a specialist referral for OC risk. The goal was to evaluate the impact of a novel approach on specialist referral compliance in individuals with a positive OC risk screening outcome. A total of 60 LRMU subjects who had screened positive for increased OC risk were recruited and given the choice of referral for an in-person (20 subjects) or a telehealth (40 subjects) specialist visit. Referral compliance was tracked weekly over 6 months. Compliance was 30% in the in-person group, and 83% in the telehealth group. Approximately 83-85% of subjects from both groups who had complied with the first specialist referral complied with a second follow-up in-person specialist visit. Overall, 72.5% of subjects who had chosen a remote first specialist visit had entered into the continuum of care by the study end, vs. 25% of individuals in the in-person specialist group. A two-step approach that uses telehealth to overcome barriers may improve specialist referral compliance in LRMU individuals with increased OC risk.

A randomized double-blind clinical trial evaluating comparative plaque and gingival health associated with commercially available stannous fluoride-containing dentifrices as compared to a sodium fluoride control dentifrice.

BACKGROUND: Gingivitis is a non-specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflammation, is desirable to prevent and treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a new stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra acetic acid (EDTA) as an anti-tartar agent to reduce plaque index and gingival index over a 3-month study period compared to other commercially-available fluoride-containing dentifrices. METHODS: This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using one of five commercially available fluoride-containing dentifrices The dentifrices tested contained: 0.454% stannous fluoride and 2.6% EDTA (D1), 0.24% sodium fluoride (C), and 0.454% stannous fluoride (D2-D4). One hundred fifty subjects participated over a 3-month period. Co-primary endpoints were improvements in plaque index (PI) and modified gingival index (mGI) from baseline values. No professional cleaning was performed during the study period. RESULTS: All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using dentifrice 1 (D1) showed statistically significantly greater reductions in PI, mGI, and modified sulcular bleeding index (mSBI) compared with all other commercially-available dentifrices tested (p < 0.00001). CONCLUSIONS: A new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with gingivitis compared to other sodium and stannous fluoride containing dentifrices.

Novel Approach to Improving Specialist Access in Underserved Populations with Suspicious Oral Lesions.

Late detection and specialist referral result in poor oral cancer outcomes globally. High-risk LRMU populations usually do not have access to oral medicine specialists, a specialty of dentistry, whose expertise includes the identification, treatment, and management of oral cancers. To overcome this access barrier, there is an urgent need for novel, low-cost tele-health approaches to expand specialist access to low-resource, remote and underserved individuals. The goal of this study was to compare the diagnostic accuracy of remote versus in-person specialist visits using a novel, low-cost telehealth platform consisting of a smartphone-based, remote intraoral camera and custom software application. A total of 189 subjects with suspicious oral lesions requiring biopsy (per the standard of care) were recruited and consented. Each subject was examined, and risk factors were recorded twice: once by an on-site specialist, and again by an offsite specialist. A novel, low-cost, smartphone-based intraoral camera paired with a custom software application were utilized to perform synchronous remote video/still imaging and risk factor assessment by the off-site specialist. Biopsies were performed at a later date following specialist recommendations. The study's results indicated that on-site specialist diagnosis showed high sensitivity (94%) and moderate specificity (72%) when compared to histological diagnosis, which did not significantly differ from the accuracy of remote specialist telediagnosis (sensitivity: 95%; specificity: 84%). These preliminary findings suggest that remote specialist visits utilizing a novel, low-cost, smartphone-based telehealth tool may improve specialist access for low-resource, remote and underserved individuals with suspicious oral lesions.

Better living through chemistry? A randomized, double-blind controlled study evaluating the efficacy of plaque control and gingival health impacts of a novel stannous fluoride-containing gel.

BACKGROUND: Gingivitis is a nonspecific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices are necessary to reverse gingivitis and a dentifrice that could provide significant clinical reductions in plaque accumulation and gingival inflammation would be desirable to treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a novel stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra-acetic acid (EDTA) as an antitartar agent to reduce Plaque Index (PI) and Gingival Index over a 3-month study period. METHODS: This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using either a novel dental gel containing 0.454% stannous fluoride and 2.6% EDTA or a dentifrice with 0.24% sodium fluoride. Sixty subjects participated over a 3-month period. Co-primary endpoints were improvements in PI and Modified Gingival Index (mGI) from baseline values. No professional cleaning was performed during the study period. RESULTS: All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using the novel dental gel showed statistically significantly greater reductions in PI (ΔPI) [(-1.43 ± 0.34; -0.49 ± 0.13) (p < 0.00001)], mGI (ΔmGI) [(-1.11 ± 0.22; -0.16 ± 0.12) (p < 0.00001)], and modified sulcular bleeding index (ΔmSBI) [(-1.15 ± 0.18; -0.20 ± 0.07) (p < 0.00001)]. CONCLUSIONS: The novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice.

Evaluating efficacy of a novel dentifrice in reducing probing depths in Stage I and II periodontitis maintenance patients: A randomized, double-blind, positive controlled clinical trial.

BACKGROUND: Compliance to periodontal maintenance therapy (PMT) is essential for long-term periodontal health. Between PMT visits, patients must maintain good oral hygiene. A dentifrice with demonstrable clinical benefits for use between PMT visits would be highly desirable. The aim of this clinical study was to investigate the effect of a novel dental gel on probing depths (PD) and inflammation when used as a home care dentifrice in Stage I and II periodontitis patients. METHODS: This double-blind clinical study randomized 65 subjects with Stage I and II periodontitis to the novel dental gel containing 2.6% EDTA, and a commercially available anti-gingivitis dentifrice with 0.454% stannous fluoride. Primary endpoint was PD at 6 months for those sites with baseline PD ≥ 4 mm and secondary endpoints included whole mouth mean scores of modified gingival index (MGI), modified sulcus bleeding index (mSBI) and plaque index (PI). No SRP was performed at baseline. RESULTS: Subjects using the novel dentifrice showed significant PD reductions of 1.18 mm (from 4.27 mm at baseline to 3.09 mm at 6 months) compared to 0.93 mm (from 4.23 mm at baseline to 3.30 mm at 6 months) shown for those using the positive control dentifrice. Difference between treatments at 6 months was 0.21 mm with P-value = 0.0126. Significant improvements in MGI (P = 0.0000), mSBI (P = 0.0000), and PI (P = 0.0102) were also observed in 6 months. CONCLUSION: The novel dentifrice showed significant reductions in PD and gingival inflammation over 6 months solely as a home care dentifrice without baseline SRP in Stage I and II periodontitis maintenance patients.

Effects of a Dental Gel Over 6 Months on Periodontal Health in Subjects with Stage II and III (Mild and Moderate) Periodontitis.

OBJECTIVE: Overall aim of this prospective, randomized, positive controlled, double-blind in vivo study was to identify the effects of a test dental gel containing 2.6% edathamil with an added carrier and permeability enhancer vs. a positive control dentifrice on periodontal health measures in patients with Stage II and III periodontitis. METHODS: In this prospective double-blinded, randomized study, 33 subjects were randomly assigned in a 1:1 ratio to brushing their teeth with either the test gel (LivFresh®, Livionex Dental Gel, Los Gatos, CA 95030) or the positive control toothpaste (Crest ProHealth®, P&G, Cincinnati, OH 45202).Full-mouth gingival index, modified sulcus bleeding index, and periodontal pocket probing depths were recorded for all teeth at baseline, and on days 90 and 180.Subjects brushed with the study material twice a day. RESULTS: The test dental gel reduced gingival inflammation and bleeding, as well as periodontal pocket probing depths significantly more than a control dentifrice. CONCLUSIONS: In this pilot study in subjects with Stage II and III periodontitis, a test dental gel was found to improve gingival inflammation and bleeding, as well as periodontal pocket depths significantly better than a control dentifrice.

Effects of a Novel Formulation on Oral Biofilm, pH Buffering, and Gingival Health in Patients with Dry Mouth.

GOAL: To identify in patients with dry mouth the effects of a novel test agent (Oral Essentials Hydrating Formula Mouthwash, Beverly Hills, CA) versus a control agent (Biotène Dry Mouth Oral Rinse, GlaxoSmithKline Consumer Healthcare L.P., Moon Township, PA, USA) versus no treatment on dry mouth, plaque, salivary pH and buffering capacity, gingival health, and tooth sensitivity. MATERIALS AND METHODS: In this cross-over study, ten subjects with dry mouth used test and control dry mouth interventions, as well as no dry mouth intervention in randomized sequence. Plaque Index, Gingival Index, Sulcus Bleeding Index, Plaque staining, and photographs were recorded at baseline and end of each study arm. Salivary volume, pH, and buffering capacity were also recorded at these time points. Additionally, subjects completed a questionnaire for dry mouth and dentinal sensitivity at each visit. RESULTS: Reductions in plaque presence and clinical indices were similar after use of test or control products (p < 0.05). Saliva volume and pH buffering improved significantly after use of test and control products (p < 0.05). CONCLUSIONS: The effects of a novel dry mouth intervention are similar to those of an existing OTC remedy and are significantly better than no intervention.

Dental Plaque Removal and Re-Accumulation: A Clinical Randomized Pilot Study Evaluating a Gel Dentifrice Containing 2.6% Edathamil.

OBJECTIVES: The goal of this clinical study was to determine the effects of a dental gel containing 2.6% edathamil on overnight plaque re-accumulation and plaque removal. METHODS: In this double-blind, randomized crossover study, 10 subjects first brushed for one week with a washout toothpaste. On the evening of Day 7, prior to tooth brushing, Plaque Index (PI) was recorded, then plaque stained and photographed. Subsequently subjects were randomized to either brush with the test dental gel or the control. After overnight plaque accumulation, PI was recorded. Plaque was stained and photographed before and after subjects brushed with the same toothpaste as the previous night. Subsequently, the process was repeated with the second toothpaste. Image J software was used to quantify plaque presence. RESULTS: Mean increase in PI overnight after brushing (1.78 versus 0.94) and final PI after tooth brushing the next morning (2.20 versus 1.31) were significantly (p < 0.05) better after use of the test gel. Tooth surface covered by plaque overnight was significantly higher after using the control gel (22.3%) than the test gel (11.8%; p < 0.05). After morning brushing, the residual area of plaque on the teeth was significantly higher for the control gel (9.2%) than for the test gel (3.6%; (p < 0.05). CONCLUSIONS: A test dental gel more effectively reduced overnight plaque re-accumulation and achieved better plaque removal than a control dentifrice.

A Double-Blinded, Randomized Study Evaluating the In Vivo Effects of a Novel Dental Gel on Enamel Surface Microstructure and Microhardness.

OBJECTIVES: The objective of this study was to evaluate the in vivo effects of a 2.6% edathamil gel (Livionex® Dental Gel) on surface microhardness and microstructure in 180 pre-eroded enamel chips. METHODS: This was a double-blind, randomized study. Two enamel chips each were cut from 90 healthy sterilized extracted teeth. One chip from each pair underwent microhardness testing and scanning electron microscopy (SEM) to establish baselines. The remaining 90 samples were demineralized, and then mounted onto intra-oral retainers worn by nine subjects, with five chips mounted on each retainer for each of the two study arms. In one two-week study arm subjects brushed with the control toothpaste; in the other they used the test gel. Study arms were separated by a two-week washout. Sequence of toothpaste use was randomized. At the end of each study arm, samples underwent microhardness measurements (Knoop) and SEM visualization. RESULTS: After intraoral wear, enamel chips recovered fully from demineralization, with no significant difference in microhardness between the two treatments (p > 0.05). In SEM images, enamel surfaces at study's end also appeared comparable in the two groups. CONCLUSIONS: Pre-eroded enamel chips remineralized intra-orally to a similar level after using a control or a test toothpaste containing 2.6% edathamil.

Evaluating the Whitening and Microstructural Effects of a Novel Whitening Strip on Porcelain and Composite Dental Materials.

AIMS: The aim of this project was to evaluate the effects of 2 different whitening strips on color, microstructure and roughness of tea stained porcelain and composite surfaces. METHODS: 54 porcelain and 72 composite chips served as samples for timed application of over-the-counter (OTC) test or control dental whitening strips. Chips were divided randomly into three groups of 18 porcelain and 24 composite chips each. Of these groups, 1 porcelain and 1 composite set served as controls. The remaining 2 groups were randomized to treatment with either Oral Essentials® Whitening Strips or Crest® 3D White Whitestrips™. Sample surface structure was examined by light microscopy, profilometry and Scanning Electron Microscopy (SEM). Additionally, a reflectance spectrophotometer was used to assess color changes in the porcelain and composite samples over 24 hours of whitening. Data points were analyzed at each time point using ANOVA. RESULTS: In the light microscopy and SEM images, no discrete physical defects were observed in any of the samples at any time points. However, high-resolution SEM images showed an appearance of increased surface roughness in all composite samples. Using profilometry, significantly increased post-whitening roughness was documented in the composite samples exposed to the control bleaching strips. Composite samples underwent a significant and equivalent shift in color following exposure to Crest® 3D White Whitestrips™ and Oral Essentials® Whitening Strips. CONCLUSIONS: A novel commercial tooth whitening strip demonstrated a comparable beaching effect to a widely used OTC whitening strip. Neither whitening strip caused physical defects in the sample surfaces. However, the control strip caused roughening of the composite samples whereas the test strip did not.

Effects of a Novel Whitening Formulation on Dental Enamel.

OBJECTIVE: The goal of this study was to evaluate the enamel whitening effects of 2 new test formulations, one of which was a rinse, and the other a whitening strip. MATERIALS AND METHODS: Forty enamel chips were prepared from 20 healthy extracted teeth (2 from each tooth). After pre-staining and colorimetry to measure L* and b* values, 20 matched samples were immersed in either test or control rinses, and then colorimetry was performed again after 1 hr, 2 hr, 3 hr, 6 hr, 12 hr, 24 hr and 48 hrs (Each hour equates to one month of clinical use at the recommended dosage of 1 minute exposure 2 times a day). The remaining 20 matched samples were exposed to the test or control whitening strips and colorimetry was performed every 30 minutes for a total of 10 treatments. RESULTS: Overall, the whitening performance of test and control strips was similar. The test and control rinses had a similar lightening effect over the first 3 hours (equivalent to 3 months of clinical use). Subsequently, the control rinse continued to lighten samples, whereas the test rinse had little further effect. CONCLUSION: Test and control-whitening strips showed similar effects; over time whitening strips showed a greater lightening effect than whitening rinses.

Effects of A Novel Disc Formulation on Dry Mouth Symptoms and Enamel Remineralization in Patients With Hyposalivation: An In Vivo Study.

BACKGROUND: The goal of this study was to identify the in vivo effects in patients with hyposalivation of a novel slowly dissolving adhering test disc upon on enamel remineralization, oral biofilm, salivary production, pH and buffering, gingival health, and on self-evaluation of oral well-being. METHODS: Five subjects with xerostomia wore custom made retainers carrying 5 demineralized enamel chips for periods of 1 week each. In 1 study arm, subjects used the test agent plus oral hygiene self-care; in the other they used oral hygiene self-care only, with a 1 week washout in between arms. The treatment sequence was randomized. Before and after each study arm Plaque Index (PI), Gingival Index (GI) and Sulcus Bleeding Index (mSBI) were recorded. Clinical plaque staining was quantified using digital image analysis. Saliva production, pH and buffering capacity were recorded. Subjects completed a self-evaluation questionnaire for oral comfort. Enamel samples underwent standardized Knoop microhardness testing to quantify mineralization status. RESULTS: Plaque presence and clinical Plaque Indices decreased significantly with test agent use (p<0.05). Five-minute saliva production almost doubled 10 and 40 minutes after oral test disc insertion (significant, p<0.05). Salivary pH buffering improved in 4/5 subjects with disc use. All demineralized tooth samples re-hardened intraorally (p>0.05). The discs favorably impacted eating problems and dental sensitivity. Subjects were positive about disc flavor and mouth feel. CONCLUSION: Using established in vivo techniques, the effects of a novel product in xerostomic patients were evaluated and quantified. The adhering disc facilitated eating, reduced dental sensitivity, improved saliva production and buffering capacity, reduced plaque, and alleviated xerostomia symptoms. CLINICAL RELEVANCE: Xerostomia management is challenging. A novel dry mouth disc was effective in alleviating dry mouth symptoms.

Effects of a Novel Mouthwash on Dental Remineralization.

OBJECTIVE: The goal of this study was to evaluate the in vivo effects of a novel mouthwash on enamel remineralization. MATERIALS AND METHODS: Ten healthy volunteers wore removable intra-oral appliances for three study arms with duration of 5 days each. In 1 study arm, subjects used Oral Essentials Sensitivity FormulaR mouthwash; in another arm they used SensodyneR mouthwash, and in the third arm they used no mouthwash at all. Sequence of mouthwash use was randomized, and study participants and researchers were blinded throughout the study. Subjects used Crest Total CareR toothpaste throughout the study. During a one week washout period before study begin and between each study arm, subjects also used Crest Total CareR toothpaste. A total of 300 enamel samples were included in this study, 150 served as baseline controls, and 150 as test samples subjected to demineralization prior to intra-oral wear. At the end of each study arm, enamel chips were removed from the appliance and underwent standard Microhardness (Knoop) measurements, as did the control samples. Enamel microhardness in the test vs the 2 control groups was compared using the Kruskal-Wallis one-way analysis of variance with post-hoc Tukey's test to test for differences in remineralization between the 3 treatments. RESULTS: Both mouthwashes demonstrated similar levels of recovery from demineralization as the "no mouthwash" arm of the study, with no significant differences for all groupings and comparisons (p>0.05). CONCLUSION: A novel mouthwash for sensitive teeth supports enamel recovery from demineralization.

Design and evaluation of a miniature laser speckle imaging device to assess gingival health.

Current methods used to assess gingivitis are qualitative and subjective. We hypothesized that gingival perfusion measurements could provide a quantitative metric of disease severity. We constructed a compact laser speckle imaging (LSI) system that could be mounted in custom-made oral molds. Rigid fixation of the LSI system in the oral cavity enabled measurement of blood flow in the gingiva. In vitro validation performed in controlled flow phantoms demonstrated that the compact LSI system had comparable accuracy and linearity compared to a conventional bench-top LSI setup. In vivo validation demonstrated that the compact LSI system was capable of measuring expected blood flow dynamics during a standard postocclusive reactive hyperemia and that the compact LSI system could be used to measure gingival blood flow repeatedly without significant variation in measured blood flow values (p<0.05). Finally, compact LSI system measurements were collected from the interdental papilla of nine subjects and compared to a clinical assessment of gingival bleeding on probing. A statistically significant correlation (?=0.53; p<0.005) was found between these variables, indicating that quantitative gingival perfusion measurements performed using our system may aid in the diagnosis and prognosis of periodontal disease.

Effects of a Novel Dental Gel on Enamel Surface Recovery from Acid Challenge.

BACKGROUND: Objective was to evaluate the in vivo effects of a novel dental gel (Livionex gelR) vs. a comparison dental gel on the surfaces of pre-eroded enamel chips. METHODS: On days 1-5, after toothbrushing with dentifrice, nine subjects each wore 8 enamel chips mounted on a palatal appliance for 4 h. Enamel blocks were pre-demineralized daily. After 2 day washout, subjects repeated the protocol using fresh chips and the second toothpaste on days 8-12. Samples were evaluated using electron microscopy. RESULTS: Ten standardized enamel surface photomicrographs/sample (total 1440 images) were evaluated for signs of erosion visually and on a scale of 0-3 by 1 evaluator. No significant differences were found between the 2 groups (p>0.32, 95% C.I.). Minimal surface erosion on approx. 15% of sample area was visible in both groups. CONCLUSION: The enamel surface appeared similar after usage of a test or control dentifrice. Based on this study, the test formulation did not affect enamel surface recovery from an erosive challenge. PRACTICAL IMPLICATIONS: Dentifrices can contribute to maintaining a healthy enamel surface. An all-natural dental gel formulation with novel anti-plaque mechanism achieved similar recovery from acid challenge to enamel as a control gel.