Validation of a Point-of-Care Optical Coherence Tomography Device with Machine Learning Algorithm for Detection of Oral Potentially Malignant and Malignant Lesions.

Non-invasive strategies that can identify oral malignant and dysplastic oral potentially-malignant lesions (OPML) are necessary in cancer screening and long-term surveillance. Optical coherence tomography (OCT) can be a rapid, real time and non-invasive imaging method for frequent patient surveillance. Here, we report the validation of a portable, robust OCT device in 232 patients (lesions: 347) in different clinical settings. The device deployed with algorithm-based automated diagnosis, showed efficacy in delineation of oral benign and normal (n = 151), OPML (n = 121), and malignant lesions (n = 75) in community and tertiary care settings. This study showed that OCT images analyzed by automated image processing algorithm could distinguish the dysplastic-OPML and malignant lesions with a sensitivity of 95% and 93%, respectively. Furthermore, we explored the ability of multiple (n = 14) artificial neural network (ANN) based feature extraction techniques for delineation high grade-OPML (moderate/severe dysplasia). The support vector machine (SVM) model built over ANN, delineated high-grade dysplasia with sensitivity of 83%, which in turn, can be employed to triage patients for tertiary care. The study provides evidence towards the utility of the robust and low-cost OCT instrument as a point-of-care device in resource-constrained settings and the potential clinical application of device in screening and surveillance of oral cancer.

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.

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.

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.

Plaque Removal and Gingival Health after Use of a Novel Dental Gel: A Clinical Study.

BACKGROUND: Goal of this in vivo prospective, randomized, controlled, double-blinded, cross over study was to compare the level of plaque control and gingivitis after use of a novel dental gel (test) vs. A Triclosan/copolymer dentifrice (control). METHODS: After coronal polishing, 22 subjects with moderate gingivitis were randomly assigned to brush twice daily with test or control dentifrice for the first study Arm. Plaque, gingival and sulcus bleeding indices were recorded at baseline, week 2 and week 4. Professional coronal polishing was repeated, and then subjects brushed with the second dentifrice for 4 weeks. Clinical indices were again recorded at Baseline, week 2 and week 4. The effects of each dentifrice on clinical indices were compared using Student's t-test. RESULTS: Brushing with the test gel produced significantly greater levels of plaque reduction versus the Triclosan/copolymer control dentifrice at each time point. 45% less plaque was measured after 4 weeks of test agent use than after control agent use (p<0.000000005). A significant reduction in gingival inflammation from test vs control agent over w\4 weeks was also observed (p=0.000342). CONCLUSIONS: An activated edathamil dental gel formulation provides effective plaque control and reduced gingival inflammation compared to a Triclosan/Co-polymer dental gel. Practical Implications: A novel dental gel formulation that does not contain abrasives, detergents or antimicrobials may provide effective plaque control and support gingival health.