A 4-week randomized controlled trial evaluating plaque and gingivitis effects of an electric toothbrush in a paediatric population.

BACKGROUND: Few extended studies have explored oscillating-rotating (O-R) toothbrush efficacy in young children. AIM: To compare the efficacy between O-R and manual toothbrushes in reducing plaque and gingivitis after 4 weeks in children. DESIGN: This was a randomized, parallel-group, examiner-blind, clinical trial. In two 50-subject cohorts (3-6 years, primary dentition, parental brushing; 7-10 years, mixed dentition, self-brushing), subjects used Oral-B Kids O-R toothbrush per manufacturer's instructions or Paro Junior manual toothbrush in a customary manner. Plaque and Modified Gingival Index (MGI; primary variable) scores were assessed at baseline and Week 4 for all subjects and within each age group. RESULTS: Both toothbrushes significantly reduced whole mouth and posterior plaque and MGI versus baseline (p < .001). Combined groups: O-R showed greater plaque and MGI reductions versus manual for all measures (p ≤ .003). Three- to 6-year-olds: O-R demonstrated significantly (p < .032) greater whole-mouth (55.7%) and posterior (34.3%) plaque reductions at Week 4 versus manual. Seven- to 10-year-olds: O-R showed significantly (p < .001) greater whole-mouth (94.5%) and posterior (108.4%) plaque reductions and greater (p ≤ .016) whole-mouth (14.1%) and posterior (18.8%) MGI reductions versus manual. There were no adverse events. CONCLUSION: The O-R toothbrush, used per manufacturer's instructions, reduced plaque and gingivitis better than a manual toothbrush used in a customary manner among children.

Prospective comparison of diagnostic tests for bile acid diarrhoea.

BACKGROUND: Bile acid diarrhoea is often missed because gold standard nuclear medicine tauroselcholic [75-Se] acid (SeHCAT) testing has limited availability. Empirical treatment effect has unknown diagnostic performance, whereas plasma 7α-hydroxy-4-cholesten-3-one (C4) is inexpensive but lacks sensitivity. AIMS: To determine diagnostic characteristics of empirical treatment and explore improvements in diagnostics with potential better availability than SeHCAT. METHODS: This diagnostic accuracy study was part of a randomised, placebo-controlled trial of colesevelam. Consecutive patients with chronic diarrhoea attending SeHCAT had blood and stool sampled. Key thresholds were C4 > 46 ng/mL and SeHCAT retention ≤10%. A questionnaire recorded patient-reported empirical treatment effect. We analysed receiver operating characteristics and explored machine learning applied logistic regression and decision tree modelling with internal validation. RESULTS: Ninety-six (38%) of 251 patients had SeHCAT retention ≤10%. The effect of empirical treatment assessed with test results for bile acid studies blinded had 63% (95% confidence interval 44%-79%) sensitivity and 65% (47%-80%) specificity; C4 > 46 ng/mL had 47% (37%-57%) and 92% (87%-96%), respectively. A decision tree combining C4 ≥ 31 ng/mL with ≥1.1 daily watery stools (Bristol type 6 and 7) had 70% (51%-85%) sensitivity and 95% (83%-99%) specificity. The logistic regression model, including C4, the sum of measured stool bile acids and daily watery stools, had 77% (58%-90%) sensitivity and 93% (80%-98%) specificity. CONCLUSIONS: Diagnosis of bile acid diarrhoea using empirical treatment was inadequate. Exploration suggested considerable improvements in the sensitivity of C4-based testing, offering potential widely available diagnostics. Further validation is warranted. CLINICALTRIALS: gov: NCT03876717.

Efficacy and safety of colesevelam for the treatment of bile acid diarrhoea: a double-blind, randomised, placebo-controlled, phase 4 clinical trial.

BACKGROUND: Bile acid diarrhoea is a common but overlooked cause of chronic watery diarrhoea. Plasma 7α-hydroxy-4-cholesten-3-one (C4) is an alternative to the gold standard tauroselcholic [75Se] acid (SeHCAT) test. Low-certainty evidence supports sequestrant treatment, including colesevelam. We aimed to determine the efficacy and safety of colesevelam in bile acid diarrhoea. METHODS: In this randomised, double-blind, placebo-controlled, investigator-initiated phase 4 trial of the sequestrant colesevelam in bile acid diarrhoea (SINBAD), we enrolled consecutive patients aged 18-79 years without inflammatory bowel disease attending SeHCAT testing for suspected bile acid diarrhoea at four Danish secondary care centres. Participants were randomly allocated 1:1 to receive 12 days of treatment with colesevelam (overencapsulated tablets of 625 mg) or placebo, with the starting dose of two capsules twice daily and titrated to effect during the first 5 days of treatment. A pharmacist independent of the clinical investigators generated a randomisation list on the web page randomization.com using block randomisation (randomisation was not stratified). C4 and SeHCAT diagnostic results were blinded during treatment. We treated all patients with diarrhoea, with a daily mean of 3·0 or more bowel movements or 1·0 or more watery bowel movements (Bristol stool scale type 6 and 7). Remission was defined as the absence of both these criteria during treatment days 6-12. The primary outcome was the intention-to-treat remission rate in bile acid diarrhoea diagnosed by C4 concentration greater than 46 ng/mL. A secondary outcome was the intention-to-treat remission rate in bile acid diarrhoea diagnosed by SeHCAT retention of 10% or less. This trial is registered with ClinicalTrials.gov, NCT03876717. FINDINGS: Between Oct 25, 2018, and July 1, 2021, 168 patients were randomly assigned to receive colesevelam (n=84) or placebo (n=84). 41 patients had C4 concentration greater than 46 ng/mL (22 assigned to the colesevelam group and 19 to the placebo group). For the C4-defined primary outcome, 14 (64%) of 22 participants receiving colesevelam versus three (16%) of 19 participants receiving placebo achieved remission (adjusted odds ratio 9·1, 95% CI 1·9-62·8; p=0·011). For the SeHCAT-defined secondary outcome, 75 of the 168 participants had retention of less than 10% (37 assigned to the colesevelam group and 38 assigned to the placebo group); 22 (59%) of 37 participants receiving colesevelam achieved remission versus five (13%) of 38 participants receiving placebo (adjusted odds ratio 11·1, 95% CI 3·4-45·6; p=0·00020). There were no serious adverse events. Common adverse events were transient. For patients receiving colesevelam within the primary outcome population, five had abdominal pain, nine had bloating, and four had nausea. For patients receiving placebo, four had abdominal pain, four had bloating, and one had nausea. No participants with bile acid diarrhoea withdrew due to adverse events. INTERPRETATION: Colesevelam was superior to placebo at inducing remission of bile acid diarrhoea diagnosed with C4 concentration greater than 46 ng/mL. Secondary outcome data suggest similar efficacy treating SeHCAT-defined bile acid diarrhoea. Colesevelam was safe during the treatment. FUNDING: Fabrikant Vilhelm Pedersen og hustrus mindelegat; recommended by the Novo Nordisk Foundation.

Gingival health effects with an oscillating-rotating electric toothbrush with micro-vibrations and a novel brush head designed for stain control: Results from a 12-week randomized controlled trial.

PURPOSE: To evaluate the reduction of plaque and gingivitis by an oscillating-rotating (O-R) smart-connected electric rechargeable toothbrush with micro-vibrations used with a novel brush head designed for stain control versus a manual toothbrush. METHODS: 100 adult subjects with evidence of gingivitis and plaque were enrolled in this single-center, examiner-blind, two-treatment, parallel-group, controlled trial. Subjects were randomized to either the O-R toothbrush used in whitening mode (Oral-B iO with Radiant White brush head) or the manual toothbrush (Oral-B Indicator). Subjects brushed twice daily with their assigned toothbrush and a standard sodium fluoride dentifrice. At baseline, week 1, and week 12, gingivitis was assessed with the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI), and plaque was assessed with the Rustogi Modification of the Navy Plaque Index (RMNPI). Gingival case status was classified as " healthy" (< 10% bleeding sites) or "not healthy" (≤ 10% bleeding sites) according to the standard of the American Academy of Periodontology and the European Federation of Periodontology. RESULTS: All 100 subjects who were randomized to treatment completed the study. At baseline, the gingival case status for all subjects was classified as "not healthy". By week 12, 86% of subjects in the O-R brush group had transitioned to a " healthy" case status, in contrast to 20% of subjects in the manual toothbrush group (P< 0.001). The reduction in the adjusted mean number of bleeding sites from baseline was greater for the O-R brush group than for the manual brush group [at week 12, by 24.5 (74.6%) vs. by 7.8 (23.7%), respectively; P< 0.001]. Reductions for adjusted mean MGI and GBI scores were likewise statistically significantly greater for the O-R brush group relative to those of the manual brush group (P< 0.001). The O-R brush also provided greater relative reductions in adjusted mean whole mouth, gingival margin and approximal RMNPI scores at week 12 (P< 0.001), and plaque was similarly reduced in the lingual and buccal subregions (P< 0.001). Significant between-group plaque reductions favoring the O-R brush were observed for all regions as early as first use (P< 0.001). CLINICAL SIGNIFICANCE: The results of this 12-week study support the recommendation of the O-R toothbrush with micro-vibrations, used in whitening mode with a novel brush head designed for stain control, so patients motivated by esthetic desires can personalize their brushing experience without compromising cleaning and gingival health efficacy.

A 12-Week Randomized Controlled Trial Comparing a Novel Electric Toothbrush With an Extra Gentle Brush Head to a Manual Toothbrush for Plaque and Gingivitis Reduction.

OBJECTIVE: This study compared the gingivitis and plaque reduction efficacy of a novel smart-connected oscillating-rotating (O-R) electric toothbrush with micro-vibrations, used in Sensitive mode with an extra gentle ("sensitive") brush head, to the efficacy of a soft manual toothbrush. METHODS: This was a 12-week, examiner-blind, two-treatment, parallel-group clinical trial with 100 adult subjects (N = 100) having evidence of gingivitis and plaque at baseline. Subjects were randomly assigned to use either the O-R electric rechargeable toothbrush (Oral-B iO with Oral-B Gentle Care brush head) or the soft manual toothbrush (Oral-B Indicator). Gingivitis was assessed with the modified gingival index (MGI) and the gingival bleeding index (GBI). Plaque was assessed with the Rustogi modification of the navy plaque index (RMNPI). Patients were classified as having a "healthy" or "not healthy" gingival case status according to the criteria of the American Academy of Periodontology and the European Federation of Periodontology. Efficacy assessments and oral soft-tissue examinations were conducted before brushing at baseline, week 1, and week 12. The baseline assessment included both pre- and post-brushing plaque evaluations to evaluate single-use plaque removal efficacy. RESULTS: All 100 subjects completed the trial. Subjects had a mean age of 49.1 years; 72% were females. The O-R brush group had a significantly higher percentage of subjects who transitioned from "not healthy" to "healthy" gingival case status than did the manual brush group. Plaque reduction for the O-R brush group was also significantly greater (P ≤ .009) than for the manual brush group for whole mouth, gingival margin, and interproximal region, from day 1 (single use) through 12 weeks. Both brushes were well tolerated. CONCLUSION: The novel O-R toothbrush with micro-vibrations used in Sensitive mode with an extra gentle brush head provided significantly greater gingivitis and plaque reduction than did a manual toothbrush over 12 weeks.

Anti-gingivitis and Anti-plaque Efficacy of an Oral Hygiene System: Results From a 12-Week Randomized Controlled Trial.

The objective of this study was to compare the antigingivitis and antiplaque efficacy of an oral hygiene system versus a control regimen. This was a single-center, randomized, examiner-blind, two-treatment, 12-week parallel group study in adults with evidence of gingivitis and plaque. Eligible subjects were stratified by baseline gingivitis and plaque scores, number of bleeding sites, and tobacco use and randomized to one of two treatment groups: (1) oral hygiene system (test group) involving a novel smart-connected Oral-B® iO oscillating-rotating (O-R) electric toothbrush, 0.454 percent stabilized stannous fluoride (SnF2) dentifrice, 0.07 percent cetylpyridinium chloride (CPC) rinse, and floss, or (2) control regimen involving a manual toothbrush and 0.243 percent sodium fluoride dentifrice. Gingivitis (modified gingival index, gingival bleeding index) and plaque (Rustogi modification of the navy plaque index) were assessed at Baseline, Week 1, and Week 12.

Effects of an oral hygiene regimen on progression of gingivitis/early periodontitis: A randomized controlled trial.

Background: Periodontal disease continues to be prevalent globally, but little clinical research has been undertaken to evaluate the long-term benefits of a daily oral hygiene regimen on progression of gingivitis/early periodontitis. The objective of this study was to evaluate the effects of an oral hygiene regimen (OHR) on the periodontal health of adults in good general health with established gingivitis and early periodontitis over 24 months. Methods: A randomized controlled trial was conducted in adults with established gingivitis, with isolated sites of probing pocket depth >4 mm. Study participants were randomized to the OHR (bioavailable stannous fluoride dentifrice, oscillating-rotating electric toothbrush, cetylpyridinium chloride rinse, and floss; P&G) or usual care products (sodium fluoride dentifrice and manual toothbrush; P&G) groups. At baseline and every 6 months, gingivitis and periodontal measures were assessed and a prophylaxis was conducted. The primary outcome was Gingival Bleeding Index-Bleeding Sites (GBI-BS). Analyses used ANCOVA at 5% significance levels. Results: A total of 107 individuals were enrolled; 87 completed the study. Mean GBI-BS, Modified Gingival Index, and Probing Pocket Depth (PPD) scores were significantly lower at each visit for the OHR versus usual care group by 28% to 39%, 12% to 18%, and 6% to 13%, respectively (p≤ 0.0009). The magnitude of reduction in median number of ≥2 mm PPD loss events for OHR versus the usual care group at 24 months was 74%. Conclusion: Long-term use of the OHR produced significant periodontal health improvements versus the usual care products.

Contexte: La maladie parodontale continue d'être prévalente sur le plan mondial, mais peu de recherches cliniques ont été effectuées pour évaluer les avantages à long terme d'un régime d'hygiène buccodentaire sur la progression de la gingivite ou de la parodontite précoce. L'objectif de cette étude était d'évaluer les effets d'un régime d'hygiène buccodentaire (RHB) sur la santé parodontale des adultes en bonne santé générale qui présentent une gingivite établie et une parodontite précoce au cours de 24 mois. Méthodologie: Un essai contrôlé randomisé a été effectué chez des adultes présentant une gingivite établie et des sites isolés de profondeurs de poches au sondage >4 mm. Les participants de l'étude ont été confiés à un groupe de RHB aléatoire (pâte dentifrice au fluorure stanneux biodisponible, une brosse à dents électrique rotative et oscillante, un rince-bouche au chlorure de cétylpyridinium et la soie dentaire; P & G) ou à un groupe de produits de soins habituels (dentifrice au fluorure de sodium et une brosse à dents manuelle; P & G). La gingivite et les mesures parodontales ont été évaluées au début de l'intervention et tous les 6 mois et une prophylaxie avait été effectuée. Le résultat primaire était l'Indice de saignement gingival­les sites de saignements (ISG­SS). L'analyse de covariance a été utilisée à des seuils de signification de 5 %. Résultats: Un total de 107 personnes ont été inscrites : 87 ont terminé l'étude. Les cotes moyennes de l'ISG­SS, de l'indice gingival modifié et des cotes de profondeurs des poches au sondage (PPS) étaient significativement plus faibles à chaque visite du groupe de RHB par rapport au groupe de soins habituels, de 28 % à 39 %, 12 % à 18 % et 6 % à 13 %, respectivement (p≤ 0,0009). L'ampleur de la réduction en nombre médian d'événements de perte de PPS ≥2 mm du groupe de RHB par rapport au groupe de soins habituels était de 74 % à 24 mois. Conclusion: L'utilisation à long terme du RHB a produit des améliorations significatives de la santé parodontale par rapport aux produits de soins habituels.

Randomized clinical trial assessing anti-gingivitis efficacy of two stannous fluoride dentifrices and zinc/arginine dentifrice.

PURPOSE: To evaluate the anti-gingivitis efficacy of two bioavailable stannous fluoride (SnF2) dentifrices versus a zinc/arginine dentifrice and a negative control dentifrice, and to compare the plaque control benefits. METHODS: This was a single-center, randomized, controlled, four-treatment, parallel-group, double-blind, 3-month clinical trial. Healthy adult subjects with gingivitis were randomly assigned to one of four different dentifrice treatment groups: SnF2 dentifrice A, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + sodium hexametaphosphate (Procter & Gamble); SnF2 dentifrice B, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + citrate (Procter & Gamble); Zn/Arg dentifrice, zinc/arginine + sodium fluoride (1,450 ppm F) (Colgate-Palmolive); negative control dentifrice, sodium monofluoro-phosphate (1,000 ppm F) + sodium fluoride (450 ppm F) (Colgate-Palmolive). Subjects brushed with their assigned treatment dentifrice and an assigned manual toothbrush (Oral-B Indicator) for 1 minute, twice daily, for the duration of the study. Gingivitis was assessed at Baseline and at Weeks 2, 4 and 12 by calculating the total number of gingival bleeding sites using the Gingival Bleeding Index, and plaque was assessed at Baseline and at Week 12 using the Turesky Modified Quigley-Hein Index. A repeated measures model was carried out across Weeks 2, 4, and 12 to determine bleeding efficacy (total number of bleeding sites). An ANCOVA with baseline plaque as the covariate was used to evaluate plaque efficacy at Week 12. RESULTS: 161 subjects were randomized (mean age= 38.8 years). 154 subjects completed the study and 153 had evaluable data at Week 12. The mean (SD) number of Baseline bleeding sites overall was 78.74 (31.16) with no significant difference between groups (P= 0.537). SnF2 dentifrice A significantly reduced the number of bleeding sites relative to the negative control dentifrice at Weeks 2, 4 and 12 by 15.4%, 13.7% and 17.2%, respectively. SnF2 dentifrice B significantly reduced the number of bleeding sites relative to the negative control dentifrice at Week 4 by 13.9% (P= 0.041). Relative to the Zn/Arg dentifrice, SnF2 dentifrice A produced significantly greater reductions in gingival bleeding sites at Weeks 2, 4 and 12 by 23.4%, 17.2% and 20.9%, respectively (P≤ 0.007). SnF2 dentifrice B produced significantly greater bleeding reductions versus the Zn/Arg dentifrice at Weeks 4 and 12 by 17.4% and 14.4%, respectively (P≤ 0.035). The Zn/Arg dentifrice did not differ significantly in the number of bleeding sites (P≥ 0.127) or plaque (P= 0.175) relative to the negative control dentifrice. Both SnF2 dentifrices significantly reduced plaque levels (P≤ 0.029) relative to both negative control dentifrice and Zn/Arg dentifrice at Week 12. All dentifrices were well tolerated. CLINICAL SIGNIFICANCE: Two different SnF2 dentifrices showed significantly reduced gingival bleeding and plaque levels relative to a Zn/arginine dentifrice.

A 6-month randomized controlled trial evaluating a novel smart-connected oscillating-rotating toothbrush versus a smart-connected sonic toothbrush for the reduction of plaque and gingivitis.

PURPOSE: This 6-month study compared the effects of a smart-connected oscillating-rotating (O-R) electric rechargeable toothbrush with micro-vibrations with those of a marketed smart-connected sonic rechargeable toothbrush for the reduction of gingivitis and plaque. METHODS: In this single-center, examiner-blind, two-treatment, open-label, parallel-group, randomized study, 110 adult subjects with evidence of gingivitis and plaque were randomized to use either the O-R brush (Oral-B iO) or the sonic brush (Philips Sonicare DiamondClean). Both groups were instructed to brush twice daily with a standard sodium fluoride dentifrice. Gingivitis and plaque were assessed at baseline, week 1, and week 24 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and the Rustogi Modification of the Navy Plaque Index (RMNPI). Designation of gingivitis case status as "healthy" or " not healthy" was made according to the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. RESULTS: A significantly greater percentage of subjects in the O-R brush group versus the sonic brush group transitioned from " not healthy" to " healthy" gingivitis case status at week 24 (96.4% vs. 81.8%; P= 0.029). The O-R toothbrush produced a significantly greater reduction in adjusted mean MGI score, adjusted mean GBI score, and adjusted mean number of bleeding sites than did the sonic brush (week 24, by 32.6% for MGI score, by 23.7% for GBI score, and by 26.1% for number of bleeding sites, P< 0.001). After a single use on day 1, plaque removal was statistically significantly greater for the O-R brush compared to the sonic brush (P< 0.001); by week 24, the O-R brush demonstrated greater reductions in whole mouth plaque (24.6%), gingival margin plaque (61.9%) and approximal region plaque 25.8% (P≤ 0.007 for all) compared to the sonic brush. CLINICAL SIGNIFICANCE: This 6-month study provides evidence supporting use of a smart-connected O-R electric toothbrush with micro-vibrations for plaque removal and gingivitis reductions, resulting in transitions to a healthy gingival state.

Clinical Parameters and Oral Fluid Biomarkers in Gingivitis Subjects using an Electric Toothbrush with Irrigator vs a Manual Toothbrush Alone over 8 Weeks: A Randomised Controlled Clinical Trial.

PURPOSE: To compare clinical outcomes and oral fluid biomarkers in gingivitis subjects using an electric toothbrush/irrigator combination (test) or a manual toothbrush alone (control) over 8 weeks. MATERIALS AND METHODS: Subjects were randomly assigned to two groups of n = 30. In both groups, toothbrushing was performed twice daily at home and no additional interdental cleaning aids were allowed. Plaque Index (PLI), Gingival Index (GI), whole saliva (WS), and gingival crevicular fluid (GCF) samples were collected at weeks 2, 4, and 8. RESULTS: Subjects' mean age was 23 years and 52% were female. Overall baseline means were 1.31 for PLI, 1.07 for GI, and 34.9 for number of bleeding sites. At every follow-up visit, both groups differed statistically significantly (p < 0.001) from baseline for all clinical parameters. The test group demonstrated statistically significantly (p < 0.001) greater reductions in GI vs the control group by 18% at week 2, 17% at week 4 and 24% at week 8. The test group also demonstrated statistically significantly (p < 0.002) greater reductions in the number of bleeding sites vs the control group by 33% at week 2, 34% at week 4 and 43% at week 8. Between-group comparisons for both WS and GCF revealed numerical trends for decreased levels of interleukin (IL)-1ß in GCF after 4 and 8 weeks, but these were not statistically significant. CONCLUSION: In subjects using the electric toothbrush/irrigator combination, increased clinical improvements may be found accompanied by similarly improved trends for oral fluid biomarkers such as IL-1ß.

Randomised clinical study of plaque removal efficacy of an electric toothbrush in primary and mixed dentition.

BACKGROUND: Clinical investigations of electric toothbrushes in young children are limited. AIM: To assess plaque reduction efficacy of an oscillating-rotating electric versus manual toothbrush in a paediatric population in primary and mixed dentitions. DESIGN: In this randomised, single-brushing, 2-treatment, 4-period, replicate-use crossover study, subjects were divided into 2 age groups (3-6 years; 7-9 years) and assigned to a treatment sequence involving an Oral-B Kids electric brush and a manual brush control. Plaque was assessed pre- and post-brushing (Turesky Modified Quigley-Hein Plaque Index). Parents brushed the teeth of their children aged 3-6 years, whereas children aged 7-9 years brushed their own teeth under supervision. Plaque removal scores were analysed for brush differences in each age group separately using an analysis of covariance for crossover design. RESULTS: Forty-one children (n = 20, 3-6 years; n = 21, 7-9 years) completed the study. For the primary dentition in children 3-6 years, the electric brush reduced 32.3% more plaque than the manual brush (P = .005). For the mixed dentition in children 7-9 years, the electric brush reduced 51.9% more plaque than the manual brush (P < .001). CONCLUSIONS: An electric toothbrush reduced significantly more plaque than a manual toothbrush in 2 paediatric age groups.

Biochemical Diagnosis of Bile Acid Diarrhea: Prospective Comparison With the 75Seleno-Taurohomocholic Acid Test.

INTRODUCTION: The diagnosis of bile acid diarrhea is often missed because the availability of the seleno-taurohomocholic acid (SeHCAT) test is limited. We aimed to compare the biomarkers 7α-hydroxy-4-cholesten-3-one (C4) and fibroblast growth factor 19 (FGF19) with the SeHCAT test. METHODS: Patients with chronic diarrhea without intestinal resection referred for SeHCAT were prospectively recruited for this diagnostic accuracy study. Blood was sampled at fasting and after a stimulation meal with chenodeoxycholic acid. SeHCAT retention ≤10% defined bile acid diarrhea and >10% defined miscellaneous diarrhea. Receiver operating characteristics (ROC) were analyzed with SeHCAT as the gold standard. www.clinicaltrials.gov (NCT03059537). RESULTS: Patients with bile acid diarrhea (n = 26) had mean C4 of 30 ng/mL (95% confidence interval: 19-46) vs 8 (7-11; P < 0.001) in the miscellaneous diarrhea group (n = 45). Area under the ROC curve (ROCAUC) for C4 was 0.83 (0.72-0.93). C4 < 15 ng/mL had 85% (74%-96%) negative predictive value; C4 > 48 ng/mL had 82% (59%-100%) positive predictive value. Twenty patients had C4 values 15-48 ng/mL, of whom 11/20 had SeHCAT ≤10%. Median fasting FGF19 was 72 pg/mL (interquartile range: 53-146) vs 119 (84-240) (P = 0.004); ROCAUC was 0.71 (0.58-0.83). Stimulated FGF19 responses did not differ (P = 0.54). DISCUSSION: We identified C4 thresholds with clinically useful predictive values for the diagnosis of and screening for bile acid diarrhea in patients with chronic watery diarrhea. Further validation of the cutoff values with the placebo-controlled effect of sequestrant therapy is warranted (see Visual Abstract, Supplementary Digital Content 2, http://links.lww.com/AJG/B603).

Comparative assessment of plaque removal and motivation between a manual toothbrush and an interactive power toothbrush in adolescents with fixed orthodontic appliances: A single-center, examiner-blind randomized controlled trial.

INTRODUCTION: The objective of this 2-arm parallel trial was to determine the plaque removal efficacy (main outcome) and the motivation assessment (secondary outcome) comparing a manual versus an interactive power toothbrush in orthodontic patients. METHODS: Sixty adolescents with fixed orthodontic appliances in both arches were randomized in a 1:1 ratio in this parallel, randomized, examiner-blind controlled clinical trial. Eligibility criteria included at least 16 natural teeth, 1-6 "focus care areas," plaque score of ≥1.75, no severe caries, gingivitis and periodontitis, no dental prophylaxis, no smoking, no antibiotics, and no chlorhexidine mouth rinse. Subjects were to brush unsupervised with either an interactive power toothbrush (Oral-B Professional Care 6000, D36/EB20) with Bluetooth technology or a regular manual toothbrush (Oral-B Indicator 35 soft). Focus care areas were each brushed for 10 additional seconds. Plaque removal was assessed with the use of the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) to determine change from baseline at 2 and 6 weeks. Supervised brushing at screening and post-treatment visits recorded actual brushing times. Subject-reported motivational aspects were recorded at screening and week 6. RESULTS: Fifty-nine subjects aged 13-17 years completed the study. The interactive power toothbrush provided significantly (P <0.001) greater plaque reduction versus the manual toothbrush at 2 and 6 weeks according to the whole-mouth TMQHPI. The treatment difference in adjusted mean plaque change from baseline was 0.777 (95% CI 0.614-0.940) at week 2 and 0.834 (0.686-0.981) at week 6. Mean reductions in the number of focus care areas were also significantly greater (P <0.001) in the power brush group at weeks 2 and 6. Brushing times increased significantly at weeks 2 and 6 (P ≤0.013) versus baseline in the interactive power brush group only. Subject-reported motivation was significantly increased in the interactive power brush group at week 6 versus screening (P ≤0.005). CONCLUSIONS: An interactive power toothbrush generated increased brushing times and significantly greater plaque removal versus a manual brush.

A randomized controlled trial of a power brush/irrigator/mouthrinse routine on plaque and gingivitis reduction in orthodontic patients.

OBJECTIVES: To assess plaque and gingivitis reduction in orthodontic patients after 4 weeks' use of an oscillating-rotating power brush, irrigator, and mouthrinse. MATERIALS AND METHODS: This was a randomized, examiner-blind, clinical trial comparing plaque and gingivitis outcomes for an experimental power brush/irrigator/mouthrinse oral hygiene routine vs a dental prophylaxis followed by regular manual brushing (positive control). Fifty-one participants with fixed orthodontic appliances in the upper and lower jaw and a minimum of 15 gingival bleeding sites were randomly assigned to experimental or positive control treatment. Both groups were instructed to use their products at least twice daily. At baseline, week 1, and week 4, plaque was evaluated using digital plaque imaging analysis and a conventional subjective index. Gingival inflammation and bleeding were also measured. Analysis of covariance was used to compare groups. RESULTS: Fifty-one participants (mean age = 13.9 years) were randomized; 50 (25 per group) completed the study. At baseline, group means were not statistically different (P > .1) for gingival inflammation or bleeding. At week 4, the experimental and control groups had a 10.0% to 32.7% and 5.9% to 6.7% reduction vs baseline, respectively, in plaque (across both methods); 12.6% and 8.3% reduction, respectively, in gingival inflammation; and 50.6% and 37.8% reduction, respectively, in bleeding. At week 4, group differences favoring the experimental group were statistically significant (P < .05) for gingival inflammation, gingival bleeding, and plaque (by conventional and digital imaging indexes). CONCLUSIONS: Use of a power brush/irrigator/mouthrinse resulted in statistically significantly greater plaque and gingivitis reductions than prophylaxis followed by manual brushing in patients with fixed appliances over 4 weeks.

A randomized clinical trial to evaluate the plaque removal efficacy of an oscillating-rotating toothbrush versus a sonic toothbrush in orthodontic patients using digital imaging analysis of the anterior dentition.

OBJECTIVE: To compare the plaque removal efficacy of an oscillating-rotating electric toothbrush with an orthodontic brush head versus a sonic toothbrush in adolescent patients with fixed orthodontic appliances. MATERIALS AND METHODS: This was a randomized, examiner-blind, replicate single-use, two-treatment, four-period, crossover study with a washout period between visits of approximately 24 hours. Forty-four adolescent patients with fixed orthodontic appliances in both arches were randomized based on a computer-generated randomization schedule to one of four toothbrush treatment sequences. The primary outcome was plaque score change from baseline, measured using digital plaque imaging analysis. RESULTS: Baseline plaque levels for both brush treatments were high, covering more than 50% of the tooth area. Effective plaque removal was observed with both brush treatments (P < .001); however, the reduction in plaque with the oscillating-rotating toothbrush was statistically significantly greater (P = .017) compared with the sonic toothbrush. CONCLUSIONS: The study provides evidence for more effective plaque-removing efficacy of the oscillating-rotating toothbrush versus the sonic toothbrush among orthodontic patients.

A Randomized Controlled Clinical Trial to Evaluate the Efficacy of an Oscillating-Rotating Electric Toothbrush, a Stannous Fluoride Dentifrice, and Floss on Gingivitis.

OBJECTIVES: To evaluate the gingival health efficacy of an oscillating-rotating electric toothbrush, a stannous fluoride dentifrice, and dental floss in adults with mild-to-moderate gingivitis. METHODS: This was a single-center, randomized, controlled, examiner-blind, two-treatment, eight-week parallel group study in adults with at least 20 gingival bleeding sites. Eligible subjects were randomized equally to one of two groups: experimental oral hygiene group that included an Oral-B® oscillating-rotating electric toothbrush with round brush head (D20/EB20), Crest® stabilized stannous fluoride dentifrice (SnF2 1100 ppm F, NaF 350 ppm F), and Oral-B® Glide® floss; or regular oral hygiene control group that included a regular manual toothbrush (Oral-B® Indicator 35) and Crest® anti-cavity sodium fluoride dentifrice (NaF 1450 ppm F). Subjects followed manufacturer's instructions and used their assigned products over an eight-week period. Gingival health was measured at baseline, Week 4, and Week 8 using three assessments: Gingival Bleeding Index (GBI), number of bleeding sites, and Modified Gingival Index (MGI). Analysis of Covariance was used to compare gingival health between treatment groups. RESULTS: One hundred and twenty subjects, mean age 44 years (range: 21 to 74 years), were assessed at baseline (60 per group); 113 subjects (57 in control group, 56 in experimental group) completed the study with fully evaluable data. At baseline, the groups were balanced; overall means were 0.41 for GBI, 51.7 for bleeding sites, and 1.44 for MGI. Only the experimental group showed statistically significant reductions from baseline (p < 0.0001) for all three gingivitis assessments at both Weeks 4 and 8. At these time points, better gingival health for the experimental group was seen as significantly lower adjusted mean scores versus the control group (p < 0.0001) for all three assessments. Reductions in favor of the experimental group at Weeks 4 and 8, respectively, were 51% and 45% for GBI, 46% and 40% for number of bleeding sites, and 37% and 20% for MGI. The study treatments were well tolerated. CONCLUSIONS: Over an eight-week period, an oral hygiene routine with an oscillating-rotating electric toothbrush, stannous fluoride dentifrice, and floss significantly improved gingivitis compared to regular hygiene with a manual toothbrush and an anti-cavity sodium fluoride dentifrice.

A comparative assessment of plaque removal and toothbrushing compliance between a manual and an interactive power toothbrush among adolescents: a single-center, single-blind randomized controlled trial.

BACKGROUND: Many adolescents have poor plaque control and sub-optimal toothbrushing behavior. Therefore, we compared the efficacy of an interactive power toothbrush (IPT) to a manual toothbrush (MT) for reducing dental plaque and improving toothbrushing compliance. METHODS: In this randomized, parallel single-blind clinical study, adolescents brushed twice daily with either a MT (Oral-B® Indicator soft manual toothbrush) or an IPT (Oral-B® ProfessionalCare 6000 with Bluetooth). Subjects brushed for 2 min, plus an additional 10 s for each 'Focus Care Area'. At screening and Week 2, afternoon pre-brushing plaque was assessed via the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI), and supervised brushing duration was measured. RESULTS: Sixty subjects were randomized; 98% completed. At Week 2, the mean reduction in whole mouth plaque relative to baseline was 34% (p < 0.001) for the IPT versus 1.7% (p = 0.231) for the MT. For Focus Care Areas, the IPT yielded a 38.1% mean TMQHPI reduction (p < 0.001) versus 6.2% for the MT (p < 0.001). Mean brushing time versus baseline increased 34 s in the IPT group (p < 0.001) while remaining flat in the MT group (p = 1.0). CONCLUSIONS: Over 2 weeks, adolescents using an IPT experienced superior plaque reduction and increased overall brushing time versus those using a MT. TRIAL REGISTRATION: This trial was retrospectively registered ( ISRCTN10112852 ) on the 18th, June 2018.

Randomised clinical study of plaque removal efficacy of a power toothbrush in a paediatric population.

BACKGROUND: Clinical investigations of plaque removal efficacy of power toothbrushes in children are limited. AIM: To compare plaque removal of a power versus manual toothbrush in a paediatric population. DESIGN: This was a randomised, replicate-use, single-brushing, examiner-blinded, two-treatment, four-period crossover clinical trial in children 8-11 years of age. Subjects were randomly assigned to a treatment sequence involving an oscillating-rotating power toothbrush and a manual toothbrush control. Subjects brushed under supervision with a NaF dentifrice. Plaque was assessed pre- (baseline) and post-brushing using the Turesky Modification of the Quigley-Hein Plaque Index by two examiners. Plaque scores were averaged for mixed and permanent dentition on a per-subject basis and analysed using a mixed-model ancova for a crossover design. RESULTS: Forty-one subjects (mean 9.0 years) were randomised and completed the trial. Both the power brush and manual brush provided statistically significant mean plaque reductions versus baseline in all analyses (P < 0.001). For both examiners, plaque removal was significantly (P < 0.001) larger for the power brush in permanent and mixed dentitions. The interexaminer correlations for the permanent dentition were strong (ICC = 0.68-0.88) for pre-brushing plaque across all periods. CONCLUSIONS: An oscillating-rotating power toothbrush provided superior plaque reduction versus a manual toothbrush in children.

A 4-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush in reducing dental plaque.

PURPOSE: To assess the plaque removal efficacy of an oscillating-rotating power brush relative to a newly-introduced sonic power brush. METHODS: This study used a randomized, examiner-blind, single-center, two-treatment, parallel group 4-week design. Subjects with pre-existing plaque scores of at least 1.75 on the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) were evaluated for baseline whole mouth and approximal plaque scores. They received either the oscillating-rotating brush (Oral-B Professional Care 1000, sold as Oral-B Professional Care 600 in some regions, with the Oral-B Precision Clean brush head, D16u/EB20) or the sonic brush (Colgate ProClinical C200 with Colgate Triple Clean brush head) and brushed twice-daily with the assigned brush and a standard fluoride dentifrice for 4 weeks before returning for plaque measurements. Prior to baseline and the Week 4 measurements, participants abstained from oral hygiene for 12 hours and from eating, chewing gum and drinking for 4 hours. RESULTS: A total of 131 subjects were enrolled in the study at baseline, with all completing the study: 65 in the oscillating-rotating group, and 66 in the sonic group. Both brushes significantly reduced plaque over the 4-week study period. The oscillating-rotating brush was statistically significantly more effective in reducing plaque (P < 0.001) than the sonic brush. Compared to the sonic power brush, the adjusted mean plaque reduction scores for the oscillating-rotating power brush were more than five times greater for whole mouth and approximal areas.

Efficacy of 3 toothbrush treatments on plaque removal in orthodontic patients assessed with digital plaque imaging: a randomized controlled trial.

INTRODUCTION: Good oral hygiene is a challenge for orthodontic patients because food readily becomes trapped around the brackets and under the archwires, and appliances are an obstruction to mechanical brushing. The purpose of this study was to compare plaque removal efficacy of 3 toothbrush treatments in orthodontic subjects. METHODS: This was a replicate-use, single-brushing, 3-treatment, examiner-blind, randomized, 6-period crossover study with washout periods of approximately 24 hours between visits. Forty-six adolescent and young adult patients with fixed orthodontics from a university clinic in Germany were randomized, based on computer-generated randomization, to 1 of 3 treatments: (1) oscillating-rotating electric toothbrush with a specially designed orthodontic brush head (Oral-B Triumph, OD17; Procter & Gamble, Cincinnati, Ohio); (2) the same electric toothbrush handle with a regular brush head (EB25; Procter & Gamble); and (3) a regular manual toothbrush (American Dental Association, Chicago, Ill). The primary outcome was the plaque score change from baseline, which we determined using digital plaque image analysis. RESULTS: Forty-five subjects completed the study. The differences in mean plaque removal (95% confidence interval) between the electric toothbrush with an orthodontic brush head (6% [4.4%-7.6%]) or a regular brush head (3.8% [2.2%-5.3%]) and the manual toothbrush were significant (P <0.001). Plaque removal with the electric toothbrush with the orthodontic brush head was superior (2.2%; P = 0.007) to the regular brush head. No adverse events were seen. CONCLUSIONS: The electric toothbrush, with either brush head, demonstrated significantly greater plaque removal over the manual brush. The orthodontic brush head was superior to the regular head.