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Randomized investigation of the bioavailability of fluoride in saliva after administration of sodium fluoride, amine fluoride and fluoride containing bioactive glass dentifrices.
Naumova, EA, Staiger, M, Kouji, O, Modric, J, Pierchalla, T, Rybka, M, Hill, RG, Arnold, WH
BMC oral health. 2019;(1):119
Abstract
OBJECTIVES Bioactive glasses which degrade in aqueous solutions may release bioactive ions such as fluoride (F-) and support fluoride bioavailability in saliva. We investigated how these effects would be apparent in an in vivo experimental trial after toothbrushing in comparison with sodium fluoride and amine fluoride. MATERIAL AND METHODS In this single-center, randomized, parallel in vivo trial with a three strata block design, where healthy subjects were randomly assigned into three groups. Each group brushed their teeth either with fluoridated bioactive glass containing dentifrice, with a sodium fluoride (NaF) containing dentifrice or with amine fluoride (AmF) containing toothpaste. Saliva was collected time intervals before, immediately after, 30, 60 and 120 min after toothbrushing. Fluoride concentration was determined in supernatant saliva and salivary sediment using a fluoride ion selective electrode. The data were evaluated statistically using non-parametric tests. RESULTS The increase of bioactive fluoride in supernatant saliva was higher after application of NaF or AmF compared to fluoridated bioactive glass. In salivary sediment bioavailability of fluoride lasted longer after application of fluoridated bioactive glass. CONCLUSIONS Toothbrushing with the fluoride containing bioactive glass dentifrices had positive effects on the fluoride bioavailability within two hours. Fluoride containing bioactive glass represent a new area for investigation in caries prophylaxis. The bioactive potential impact on the tooth remineralization should be examined further. TRIAL REGISTRATION DRKS00016038 .
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Effect of phytate and zinc ions on fluoride toothpaste efficacy using an in situ caries model.
Parkinson, CR, Burnett, GR, Creeth, JE, Lynch, RJM, Budhawant, C, Lippert, F, Hara, AT, Zero, DT
Journal of dentistry. 2018;:24-31
Abstract
OBJECTIVES To compare and explore the dose-response of phytate-containing 1150 ppm fluoride toothpastes on model caries lesions and to determine the impact of zinc ions. METHODS This was a single-centre, randomised, blinded (examiner/laboratory analyst), six-treatment, four-period crossover, in situ study in adults with a removable bilateral maxillary partial denture. Study treatments were toothpastes containing: 0.425% phytate/F; 0.85% phytate/F; 0.85% phytate/Zn/F; F-only; Zn/F and a 0% F placebo. Where present, F was 1150 ppm as NaF; Zn was 0.3% as ZnCl2. Human enamel specimens containing early-stage, surface-softened (A-lesions) or more advanced, subsurface (B-lesions) caries lesions were placed into the buccal flanges of participants' modified partial denture (one of each lesion type per side). A-lesions were removed after 14 days of twice-daily treatment use; B-lesions were removed after a further 14 days. A-lesions were analysed for surface microhardness recovery. Both lesion types were analysed by transverse microradiography and for enamel fluoride uptake, with B-lesions additionally analysed by quantitative light-induced fluorescence. Comparison was carried out using an analysis of covariance model. RESULTS Statistically significant differences between 1150 ppm F and the placebo toothpastes (p < 0.05) were shown for all measures, validating the model. No differences between fluoride toothpastes were observed for any measure with little evidence of a dose-response for phytate. Study treatments were generally well-tolerated. CONCLUSIONS Results suggest phytate has little impact on fluoride's ability to promote early-stage lesion remineralisation or prevent more advanced lesion demineralisation in this in situ caries model. Similarly, results suggest zinc ions do not impair fluoride efficacy. CLINICAL SIGNIFICANCE Toothpastes may contain therapeutic or cosmetic agents that could interfere with fluoride's caries prevention efficacy. The present in situ caries study has demonstrated that phytate, added to provide enhanced extrinsic stain removal/prevention, and zinc, added to inhibit malodour, do not impair fluoride efficacy.
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Can a brief psychological intervention improve oral health behaviour? A randomised controlled trial.
Wide, U, Hagman, J, Werner, H, Hakeberg, M
BMC oral health. 2018;(1):163
Abstract
BACKGROUND Dental caries is a major public health issue affecting a large proportion of the general population. The disease is associated with behavioural factors and is thus preventable to a high degree. Individuals may need assistance to be able to change their oral health behaviour. There is a lack of such interventions for adults affected by severe caries. The aim of the study was to evaluate the effect of Acceptance and Commitment Therapy (ACT), a form of cognitive behavioural therapy, on oral health behaviour in young adults with poor oral health. METHODS The study included a two group parallel randomised controlled trial at general dental clinics, with young adults, 18-25 years of age, ≥ two manifest proximal dental caries lesions (n = 135); 67 were treated with ACT and 68 with standard disease information only, respectively. Primary outcomes: oral health behaviours (tooth-brushing, flossing, use of toothpicks, and additional fluoride use). The CONSORT principles for RCTs were used, including intention-to-treat and per protocol analyses. The Chi-square, Mann-Whitney, and Wilcoxon Signed Rank tests were applied, including effect sizes. RESULTS The study groups did not differ with regard to oral health behaviour variables at baseline. The intervention group improved all their oral health behaviours significantly over time (effect sizes, 0.26-0.32), while the control group showed improved behaviours on two measures (flossing and additional use of fluoride, effect sizes, 0.22-0.23). CONCLUSIONS By testing a psychological intervention on young adults (18-25 years of age) with a high prevalence of caries, we found an immediate positive effect with improved oral health behaviours. TRIAL REGISTRATION TRN ISRCTN15009620 , retrospectively registered 14/03/2018.
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Anticaries Potential of a Sodium Monofluorophosphate Dentifrice Containing Calcium Sodium Phosphosilicate: Exploratory in situ Randomized Trial.
Parkinson, CR, Siddiqi, M, Mason, S, Lippert, F, Hara, AT, Zero, DT
Caries research. 2017;(2):170-178
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Calcium sodium phosphosilicate (CSPS) is a bioactive glass material that alleviates dentin hypersensitivity and is postulated to confer remineralization of caries lesions. This single-centre, randomized, single (investigator)-blind, placebo-controlled, crossover, in situ study explored whether the addition of 5% CSPS to a nonaqueous fluoride (F) such as sodium monofluorophosphate (SMFP)-containing dentifrice affects its cariostatic ability. Seventy-seven subjects wore 4 gauze-covered enamel specimens with preformed lesions (2 surface-softened and 2 subsurface) placed buccally on their mandibular bilateral dentures for up to 4 weeks. Subjects brushed twice daily with 1 of the 5 study dentifrices: 927 ppm F/5% CSPS, 927 ppm F/0% CSPS, 250 ppm F/0% CSPS, 0 ppm F/5% CSPS, or 0 ppm F/0% CSPS. Specimens were retrieved after either 21 (surface-softened lesions; analyzed by Knoop surface microhardness [SMH]) or 28 days (subsurface lesions; analyzed by transverse microradiography). The enamel fluoride uptake was determined for all specimens using a microbiopsy technique. The concentrations of fluoride and calcium in gauze-retrieved plaque were also evaluated. Higher dentifrice fluoride concentrations led to greater remineralization and fluoridation of both lesion types and increased plaque fluoride concentrations. CSPS did not improve the cariostatic properties of SMFP; there were no statistically significant differences between 927 ppm F/5% CSPS and 927 ppm F/0% CSPS in percent SMH recovery (p = 0.6788), change in integrated mineral loss (p = 0.5908), or lesion depth (p = 0.6622). Likewise, 0 ppm F/5% CSPS did not provide any benefits in comparison to 0 ppm F/0% CSPS. In conclusion, CSPS does not negatively impact nor does it improve the ability of an SMFP dentifrice to affect remineralization of caries lesions.
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Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial.
Milgrom, P, Tut, O, Rothen, M, Mancl, L, Gallen, M, Tanzer, JM
BMJ open. 2017;(6):e017866
Abstract
INTRODUCTION Dental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions. The objective of this report is to describe the rationale and protocol for the trial. METHODS AND ANALYSIS The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48-84 months old. The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child's response to the treatment. ETHICS AND DISSEMINATION The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study. The study results will be published and submitted to the FDA in support of a new drug application. TRIALREGISTRATION NUMBER NCT03082196.
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A prospective randomized clinical trial into the capacity of a toothpaste containing NovaMin to prevent white spot lesions and gingivitis during orthodontic treatment.
Hoffman, DA, Clark, AE, Rody, WJ, McGorray, SP, Wheeler, TT
Progress in orthodontics. 2015;:25
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BACKGROUND White spot lesions and gingivitis represent common, yet challenging, dilemmas for orthodontists. Fluoride has shown some benefit as a protective measure against demineralization; however, this is usually insufficient for orthodontic patients with less than ideal oral hygiene. Dentifrices containing calcium sodium phosphosilicate bioactive glass (NovaMin) have been proposed to aid in prevention of white spot lesions and gingival inflammation. Thus, the purpose of this study was to determine if the use of NovaMin reduces the formation of white spot lesions and improves gingival health in orthodontic patients. METHODS This was a prospective, double-blind, randomized controlled trial. Forty-eight patients undergoing orthodontic treatment were randomly allocated to two groups. The control group consisted of 24 patients who received over-the-counter fluoride toothpaste (Crest®), while the study group consisted of 24 patients who were given the test dentifrice (ReNew™) containing 5 % NovaMin and fluoride. Patients were followed up for 6 months on a monthly basis. Decalcification, gingival health, plaque, and bacteria levels were evaluated every 3 months. Statistical analysis was performed using both parametric and non-parametric tests to identify differences between groups at different time points. RESULTS There were no significant differences between the groups in regard to changes in white spot lesions, plaque, or gingival health (P > 0.05). There was a trend toward improvement in white spot lesions found in subjects using Crest® at the 3-month time point; however, this was not sustained throughout the study. CONCLUSIONS Our results indicate that a toothpaste containing NovaMin does not differ significantly compared to traditional fluoride toothpaste for improving white spot lesions and gingivitis in orthodontic patients.
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Effects of Lactobacillus salivarius-containing tablets on caries risk factors: a randomized open-label clinical trial.
Nishihara, T, Suzuki, N, Yoneda, M, Hirofuji, T
BMC oral health. 2014;:110
Abstract
BACKGROUND To evaluate the effects of the lactic acid bacterium Lactobacillus salivarius on caries risk factors. METHODS The study was performed in 64 healthy volunteers to evaluate the effects of L. salivarius-containing tablets on caries risk factors. The participants were divided randomly into four groups, and took tablets containing L. salivarius WB21, L. salivarius TI 2711, Ovalgen® DC (antibody against glucosyltransferase from Streptococcus mutans), or xylitol. Levels of mutans streptococci and lactobacilli, amount of salivary flow, salivary pH, and salivary buffering capacity were assessed before and after taking the tablets. Subsequently, a short-term administration trial using L. salivarius WB21-containing tablets was performed in eight healthy volunteers. The participants took L. salivarius WB21-containing tablets (2.0 × 10(9) colony forming units/day) for 2 weeks, and the numbers of mutans streptococci in saliva were counted. RESULTS The levels of mutans streptococci seemed to decrease in the L. salivarius WB21, TI 2711, and Ovalgen® DC groups compared to the xylitol group, with no significant differences between the groups. Lactobacilli levels significantly increased in the L. salivarius WB21 and TI 2711 groups compared to the other groups. Concerning salivary flow and salivary pH, no significant differences were observed between the groups. The salivary buffering capacity significantly increased in the L. salivarius TI 2711 group (P = 0.003) and Ovalgen® DC group (P = 0.002) compared to the xylitol group. The short-term administration trial showed that the L. salivarius WB21-containing tablets significantly decreased the number of mutans streptococci (P = 0.039). CONCLUSION L. salivarius-containing tablets were suggested to increase resistance to caries risk factors. TRIAL REGISTRATION UMIN000013160 (registration date: February 14, 2014).
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A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years.
Newby, EE, Martinez-Mier, EA, Hara, A, Lippert, F, Kelly, SA, Fleming, N, Butler, A, Bosma, ML, Zero, DT
International dental journal. 2013;(Suppl 2):31-8
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OBJECTIVES To compare three children's sodium fluoride toothpastes to placebo with respect to enamel remineralisation potential, enamel fluoride uptake and net acid resistance using an in situ palatal caries model in children aged 11-14 years following a single brushing. DESIGN This was a randomised, single blind (laboratory analyst), single-centre, four-treatment, crossover study with a 7-day washout period between treatments. The treatments were 1,426 ppm fluoride, 1,000 ppm fluoride, 500 ppm fluoride and 0 ppm fluoride (placebo) toothpaste (NaF/silica). A custom made in situ palatal appliance was used by each subject in all treatment periods. At each of the four treatment visits subjects wore the appliance containing four partially demineralised human enamel specimens for 5 minutes and then brushed their teeth using a standardised procedure for 60 seconds under supervision using 1.0 g (±0.1 g) of their assigned toothpaste. After 4 hours the appliance was removed and enamel specimen recovered. This process was repeated until all subjects completed all four study treatment visits. Recovered enamel specimens were analysed for per cent surface microhardness recovery (%SMHR; Knoop) and enamel fluoride uptake (EFU; microdrill biopsy). Subsequently, specimens were demineralised in vitro to determine their % net acid resistance (%NAR; Knoop). RESULTS All three fluoride toothpastes demonstrated significantly greater %SMHR, EFU and %NAR compared with 0 ppm F toothpaste. The model demonstrated a dose response over the range 0 to 1,426 ppm fluoride for %SMHR, EFU and %NAR. There was no significant difference between 500 ppm F and 1,000 ppm F for %SMHR and between 1,000 ppm F and 1,426 ppm F for %SMHR, EFU and %NAR. CONCLUSIONS The present in situ study demonstrated that the children's fluoride toothpastes tested are capable of delivering cariostatic amounts of fluoride to early caries lesions following a single brushing.
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Cluster-randomized trial of infant nutrition training for caries prevention.
Chaffee, BW, Feldens, CA, Vítolo, MR
Journal of dental research. 2013;(7 Suppl):29S-36S
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The objective of this study was to estimate the caries impact of providing training in infant feeding guidelines to workers at Brazilian public primary care clinics. In a cluster-randomized controlled trial (n = 20 clinics), health care workers either were trained in guidelines for infant nutrition, stressing healthful complementary feeding, or were assigned to a 'usual practices' control, which allowed for maternal counseling at practitioner discretion. Training occurred once; the amount of counseling provided to mothers was not assessed. Eligible pregnant women were enrolled to follow health outcomes in their children. Early childhood caries (ECC) was measured at age three years (n = 458 children). The overall reductions in ECC (relative risk, 0.92; 95%CI, 0.75, 1.12) and severe ECC (RR, 0.87; 95%CI, 0.64, 1.19) were not statistically significant. There was a protective effect among mothers who remained exclusively at the same health center (S-ECC RR, 0.68; 95%CI, 0.47, 0.99) and among those naming the health center as their principal source of feeding advice (S-ECC RR, 0.53; 95%CI, 0.29, 0.97). Health care worker training did not yield a statistically significant reduction in caries overall, although caries was reduced among children of mothers more connected to their health centers.
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A prospective clinical trial on the influence of a triamcinolone/demeclocycline and a calcium hydroxide based temporary cement on pain perception.
Willershausen, B, Willershausen, I, Ehlers, V, Azaripour, A, Briseño, B
Head & face medicine. 2012;:9
Abstract
INTRODUCTION The aim of this clinical trial was to compare the degree of short term post-operative irritation after application of a triamcinolone/demeclocycyline based or a calcium hydroxide based provisional cement. METHODS A total of 109 patients (55 female and 54 male; mean age: 51 ± 14 years) with primary or secondary dentinal caries were randomly assigned to the two treatment groups of this biomedical clinical trial (phase III). Selection criteria were good systemic health and treated teeth, which were vital and showed no symptoms of pulpitis. Up to three teeth were prepared for indirect metallic restorations, and the provisional restorations were cemented with a triamcinolone/demeclocycyline (Ledermix) or a calcium hydroxide (Provicol) based material. The intensity of post-operative pain experienced was documented according to the VAS (4, 12, 20, 24, and 82 h) and compared to VAS baseline. RESULTS A total of 159 teeth were treated (Ledermix: 83 teeth, Provicol: 76 teeth). The minor irritation of the teeth, experienced prior to treatment, was similar in both groups; however, 4 h after treatment this value was significantly higher in the Provicol group than in the Ledermix group (p < 0.005, t-test). After 12 h, the difference was no longer significant. The number of patients taking analgesics for post-treatment pain was higher in the Provicol group (n = 11/53) than in the Ledermix group (n = 3/56). CONCLUSIONS The patients had no long term post-operative pain experience in both groups. However, within the first hours after cementation the sensation of pain was considerably higher in the Provicol group than in the Ledermix group.