Fluoride And Caring for Children's Teeth (FACCT): Clinical Fieldwork Protocol.

Background: The reduction in dental caries seen between Irish national surveys of children's oral health in 1984 and 2002 was accompanied by an increase in the prevalence of enamel fluorosis.  To minimise the risk of enamel fluorosis in Irish children, in 2007, the level of fluoride in drinking water was reduced from 0.8-1.0 ppm to 0.6-0.8 ppm fluoride. Recommendations on the use of fluoride toothpastes in young children were issued in 2002. Fluoride and Caring for Children's Teeth (FACCT) is a collaborative project between the Oral Health Services Research Centre, University College Cork and the Health Service Executive dental service, with funding from the Health Research Board. Aim: FACCT aims to evaluate the impact and the outcome of the change in community water fluoridation (CWF) policy (2007) on dental caries and enamel fluorosis in Irish schoolchildren, while also considering the change in policy on the use of fluoride toothpastes (2002). Methods/Design: A cross-sectional study with nested longitudinal study will be conducted in school year (SY) 2013-2014 by trained and calibrated dental examiners in primary schools in counties Dublin, Cork and Kerry for a representative sample of children born either prior to or post policy changes; age 12 (born 2001) and age 5, (born 2008). Five-year-olds will be followed-up when they are 8-year-olds (SY 2016-2017). The main explanatory variable will be fluoridation status of the children (lifetime exposure to CWF yes/no). Information about other explanatory variables will be collected via parent (of 5-, 8- and 12-year-olds) and child completed (8- and 12-year-olds only) questionnaires.  The main outcomes will be dental caries (dmf/DMF Index), enamel fluorosis (Dean's Index) and oral health-related quality of life (OHRQoL). Multivariate regression analyses will be used to determine the impact and outcome of the change in CWF policy on oral health outcomes controlling for other explanatory variables.

Water fluoridation and oral health.

UNLABELLED: Water fluoridation, is the controlled addition of fluoride to the water supply, with the aim of reducing the prevalence of dental caries. Current estimates suggest that approximately 370 million people in 27 countries consume fluoridated water, with an additional 50 million consuming water in which fluoride is naturally occurring. A pre-eruptive effect of fluoride exists in reducing caries levels in pit and fissure surfaces of permanent teeth and fluoride concentrated in plaque and saliva inhibits the demineralisation of sound enamel and enhances the remineralisation of demineralised enamel. A large number of studies conducted worldwide demonstrate the effectiveness of water fluoridation. Objections to water fluoridation have been raised since its inception and centre mainly on safety and autonomy. Systematic reviews of the safety and efficacy of water fluoridation attest to its safety and efficacy; dental fluorosis identified as the only adverse outcome. CONCLUSION: Water fluoridation is an effective safe means of preventing dental caries, reaching all populations, irrespective of the presence of other dental services. Regular monitoring of dental caries and fluorosis is essential particularly with the lifelong challenge which dental caries presents.

Randomized controlled trial to evaluate tooth stain reduction with nicotine replacement gum during a smoking cessation program.

BACKGROUND: In addition to its general and periodontal health effects smoking causes tooth staining. Smoking cessation support interventions with an added stain removal or tooth whitening effect may increase motivation to quit smoking. Oral health professionals are well placed to provide smoking cessation advice and support to patients. The objective of the present study was to evaluate the effect of Nicorette(®) Freshmint Gum used in a smoking cessation programme administered in a dental setting, on extrinsic stain and tooth shade among smokers. METHODS: An evaluator-blinded, randomized, 12-week parallel-group controlled trial was conducted among 200 daily smokers motivated to quit smoking. Participants were randomised to use either the Nicorette(®) Freshmint Gum or Nicorette(®) Microtab (tablet). Tooth staining and shade were rated using the modified Lobene Stain Index and the Vita(®) Shade Guide at baseline, weeks 2, 6 and 12. To maintain consistency with other whitening studies, the primary end-point was the mean change in stain index between baseline and week 6. Secondary variables included changes in stain measurements and tooth shade at the other time points the number of gums or tablets used per day and throughout the trial period; and the number of cigarettes smoked per day. Treatments were compared using analysis of covariance (ANCOVA), using treatment and nicotine dependence as factors and the corresponding baseline measurement as a covariate. Each comparison (modified intention-to-treat) was tested at the 0.05 level, two-sided. Within-treatment changes from baseline were compared using a paired t-test. RESULTS: At week 6, the gum-group experienced a reduction in mean stain scores whilst the tablet-group experienced an increase with mean changes of -0.14 and +0.12 respectively, (p = 0.005, ANCOVA). The change in mean tooth shade scores was statistically significantly greater in the gum-group than in the tablet group at 2 (p = 0.015), 6 (p = 0.011) and 12 weeks (p = 0.003) with greater lightening in the gum-group at each examination period. CONCLUSION: These results support the efficacy of the tested nicotine replacement gum in stain reduction and shade lightening. These findings may help dentists to motivate those wishing to quit smoking using a nicotine replacement gum. TRIAL REGISTRATION: NCT01440985.

Methodological issues in oral health research: intervention studies.

OBJECTIVES: To provide a broad overview of methodological issues in the design and evaluation of intervention studies in dental public health, with particular emphasis on explanatory trials, pragmatic trials and complex interventions. METHODS: We present a narrative summary of selected publications from the literature outlining both historical and recent challenges in the design and evaluation of intervention studies and describe some recent tools that may help researchers to address these challenges. RESULTS: It is now recognised that few intervention studies in dental public health are purely explanatory or pragmatic. We describe the PRECIS tool which can be used by trialists to assess and display the position of their trial on a continuum between the extremes of explanatory and pragmatic trials. The tool aims to help trialists make design decisions that are in line with their stated aims. The increasingly complex nature of dental public health interventions presents particular design and evaluation challenges. The revised Medical Research Council (MRC) guidance for the development and evaluation of complex interventions which emphasises the importance of planning and process evaluation is a welcome development. We briefly describe the MRC guidance and outline some examples of complex interventions in the field of oral health. The role of observational studies in monitoring public health interventions when the conduct of RCTs is not appropriate or feasible is acknowledged. We describe the STROBE statement and outline the implications of the STROBE guidelines for dental public health. CONCLUSION: The methodological challenges in the design, conduct and reporting of intervention studies in oral health are considerable. The need to provide reliable evidence to support innovative new strategies in oral health policy is a major impetus in these fields. No doubt the 'Methodological Issues in Oral Health Research' group will have further opportunities to highlight this work.

The aesthetic impact of enamel fluorosis on Irish adolescents.

OBJECTIVES: To assess the impact of differing degrees of enamel fluorosis on dental aesthetics according to Irish adolescents. The same participants also aesthetically rated other variations in dental appearances including a carious lesion, bleached teeth and a demarcated opacity. METHODS: One hundred and fifty adolescents examined seven identical template photographs of an attractive dental smile displaying varying levels of enamel fluorosis (TF1, TF2, TF3), a demarcated opacity, no fluorosis (TF0), anterior caries and very white or bleached teeth. By indicating their level of agreement or disagreement with five statements on a five-point Likert scale, the participants rated the aesthetic acceptability of each of the photographs. RESULTS: Using paired t-tests with the Bonferroni correction, it was found that the photographs depicting the very white teeth and anterior caries were rated as the most and least aesthetically pleasing images, respectively. There was no significant difference in the ratings of the photographs displaying TF0, TF1 and TF2 levels of fluorosis indicating that these photographs were viewed similarly (P>0.002). The remaining two photographs (TF3 and the demarcated opacity) were rated similarly and significantly worse (P<0.002) than the photographs showing no or low grades of fluorosis (TF0, TF1 and TF2). CONCLUSIONS: TF3 level of fluorosis represented the break point at which enamel fluorosis became aesthetically objectionable to these participants. Low grades of fluorosis (TF1 and TF2) were rated similarly to the photograph depicting no fluorosis (TF0).

Fluoride metabolism and fluorosis.

OBJECTIVES: This paper is primarily concerned with the only proven risk associated with water fluoridation: enamel fluorosis. Its purpose is to review current methods of measuring enamel fluorosis, its aetiology and metabolism. A further objective is to identify risk factors to reduce the prevalence of enamel fluorosis and employ methods to manage such risk factors. DATA: The prevalence of enamel fluorosis is increasing in Ireland and internationally. A critical period has been identified at which teeth are most at risk of developing enamel fluorosis: 15-24 months of age for males and 21-30 months of age for females. The data included took these two factors into account. SOURCE: A thorough narrative review of published literature was conducted to identify studies concerning the aetiology and metabolism of enamel fluorosis. Risk factors for fluorosis were identified from these studies. STUDY SELECTION: As it is the pre-eruptive phase of enamel development which represents the greatest risk to developing enamel fluorosis, studies examining sources of fluoride ingestion for young children were selected. These included studies on ingestion of fluoride toothpaste by young children, fluoride supplementation and infant formula reconstituted with fluoridated water. CONCLUSIONS: There is evidence that the age at which tooth brushing with fluoride toothpastes is commenced and the amount of fluoride placed on the brush are important risk factors in the incidence of dental fluorosis. It is recommended that brushing should not commence until the age of 2 and that a pea-sized amount (0.25 g) of toothpaste should be placed on the brush.

Is the fluoride level in drinking water a gold standard for the control of dental caries?

AIM: To obtain baseline knowledge of levels of dental caries in 12-year-old children residing in areas with varying levels of fluoride in drinking water in Pakistan; and to observe a dose-response relationship between the prevalence of dental caries at different concentrations of fluoride in drinking water. METHOD: Clinical examination of children and analysis of samples of drinking water. RESULTS: The maximum reduction of caries in relation to fluoride levels in Pakistan was witnessed between the fluoride concentrations of 0.00-0.33ppm. CONCLUSIONS: There are no gold standards for setting up a universal optimal level of fluoride in drinking water and each country needs to determine the concentration of fluoride in their drinking water in accordance with its socio-economic and climatic conditions, dietary and oral hygiene habits of its population, and local research to determine how much fluoride is beneficial in the control of caries.

Determining the optimal concentration of fluoride in drinking water in Pakistan.

OBJECTIVES: This study was designed to determine the optimal concentrations of fluoride for drinking water in Pakistan. Clinical dental examination of 1020 school children aged 12 years was carried out in 19 cities of Pakistan. Correlation between concentrations of water fluoride, caries and fluorosis was investigated by analyzing the data on fluoride concentrations in drinking water in the sampled population for which the caries and the fluorosis levels were also measured. METHODS: The optimal level of fluoride in drinking water is universally calculated by applying the equation of Galagan and Vermillion, which permits the calculation of water intake as a function of temperature. The annual mean maximum temperatures (AMMT) recorded during the last 5 years were collected from the meteorological centres of the 28 divisional headquarter stations. The average AMMT of Pakistan is 29 degrees C at which the optimal fluoride in drinking water of Pakistan was calculated to be 0.7 ppm. As drinking habits differ in various parts of the world, determination of optimal concentration of fluoride for drinking water in Pakistan was performed using a modified Galagan and Vermillion equation, which applies a correction factor of 0.56 to the equation. The optimal fluoride in drinking water in Pakistan using this modified equation was determined to be 0.39 ppm. RESULTS: Observation of the correlation showed that a fluoride concentration of 0.35 ppm in drinking water was associated with maximum reduction in dental caries and a 10% prevalence of fluorosis. CONCLUSIONS: Determining the most appropriate concentrations of fluoride in drinking water is crucial for communities. It is imperative that each country calculates its own optimal level of fluoride in drinking water based on the dose-response relationship of fluoride in drinking water with the levels of caries and fluorosis. Climatic conditions, dietary habits of the population and other possible fluoride exposures need to be considered in formulating these recommendations.

Fluoride ingestion from toothpaste: background to European Union-funded multicentre project.

As in most other established market economies throughout the world the prevalence of dental caries has declined in most Member States of the European Union (EU). There is evidence that the increased use of fluoride toothpaste has been a major factor in this improvement. Recently there has been increasing debate on the alleged link between increased use of fluoride toothpaste, particularly by infants and young children, and increased levels of enamel fluorosis. Central to these discussions are two issues, namely measurement of the amount of fluoride ingested by infants and young children and measurement of enamel opacities including fluorosis. The aims of the project described in this special issue addressed these two measurement issues. Seven EU Partners participated. Standardized methods for recording the amount of fluoride ingested when using fluoride toothpaste were developed and used in the seven sites. Similarly a standardized photographic method for recording enamel opacities, including fluorosis, was developed.

A review of fluorosis in the European Union: prevalence, risk factors and aesthetic issues.

Fluoride has played a key role in caries prevention for the past 50 years but excessive ingestion of fluoride during tooth development may lead to dental fluorosis. Throughout Europe many vehicles have been, and are currently, employed for optimal fluoride delivery including drinking water, toothpaste, fluoride supplements, salt and milk. Several indices, both descriptive and aetiological, have been developed and used for measuring fluorosis. This factor, combined with the lack of use of a standardized method for measurement of fluorosis, has made comparison between studies difficult and assessment of trends in fluorosis prevalence unreliable. Overall the evidence would appear to indicate, however, that diffuse enamel opacities are more prevalent in fluoridated than in nonfluoridated communities and that their prevalence at the very mild level may be increasing. In addition to fluoridated drinking water, risk factors for fluorosis include inadvertent ingestion of fluoride toothpaste and the inappropriate use of fluoride supplements. The risk is of aesthetic concern primarily during the period of enamel development of the permanent central incisors, although this largely appears to be a cosmetic rather than a public-health issue. It is concluded that there is a need to co-ordinate studies measuring fluorosis throughout Europe and that development of a standardized photographic method would be useful. Furthermore, the aesthetic importance of fluorosis needs to be determined in more detail in each country in the light of each country's respective risk factors and dental health policies.

A standardized photographic method for evaluating enamel opacities including fluorosis.

OBJECTIVES: The objective of this study was to demonstrate the reproducibility of a standardized photographic technique for recording fluorosis when used by a group of epidemiologists as part of a large multicentred European study. METHODS: Studies were first carried out to develop the equipment specification and photographic method. The author (JAC) was then trained and calibrated in this method. She was then responsible for the training and calibration of examiners from a further six European study sites. The method involved taking two transparencies of the permanent maxillary central incisors of 8-year-old children, the first after 8 s while the teeth were still wet and the second after 105 s when the teeth had been allowed to dry out naturally. Data were collected at a central location during a training/calibration exercise and subsequently, during the conduct of a large study to measure fluorosis prevalence, at the seven sites. Intra- and interexaminer reproducibility of the photographic method were measured by grading the transparencies produced by all the examiners according to the DDE and TF indices. RESULTS: The time period in which the transparencies were taken was to within 4 s among the examiners. Transparencies scored according to the TF index gave a range of Kappa values of 0.45-0.66 for intraexaminer reliability and 0.32-0.55 for interexaminer reliability. When using the DDE index Kappa values ranged from 0.43 to 0.70 for intraexaminer reliability and from 0.34 to 0.69 for interexaminer reliability. CONCLUSION: The photographic method was mostly robust and reproducible when used by epidemiologists from seven European study sites.

A comparison of the prevalence of fluorosis in 8-year-old children from seven European study sites using a standardized methodology.

OBJECTIVES: The objectives of this study were to report on the prevalence of enamel opacities from seven European study sites using a standardized photographic method, and to investigate the importance of variables responsible for enamel fluorosis. METHODS: The sample comprised a randomly selected group of 300 8-year-old children in each of the study areas. One examiner from each area was trained and calibrated in the use of a standardized photographic technique. Two transparencies were taken of each child's permanent maxillary central incisor teeth; one to represent the teeth 'wet' and one when the teeth had been allowed to dry out naturally for 105 s. The transparencies were viewed 'blind' by the author (JAC) and scored using the DDE and TF indices. Data relating to variables considered to be associated with enamel fluorosis were also collected. RESULTS: The prevalence of diffuse opacities ranged from 61% in fluoridated Cork (Ireland) to 28% in Athens (Greece). The percentage of subjects with a TF score of three or more ranged from 4% in Cork and nonfluoridated Haarlem (the Netherlands) to zero in Oulu (Finland) and Athens. Fluoridated water and the prolonged use of fluoride tablets were found to be significant contributory factors to fluorosis. CONCLUSIONS: The prevalence of fluorosis was found to be highest in fluoridated Cork. The prolonged use of fluoride supplements was also found to be a significant risk indicator associated with fluorosis.

Parental perception of fluorosis among 8-year-old children living in three communities in Iceland, Ireland and England.

OBJECTIVES: To assess the impact of enamel fluorosis in three of the communities examined in 'Project FLINT', it was decided to conduct a structured telephone interview with the parents of some of the children who took part in the study. METHODS: Three communities involved in this project were able to conduct this investigation: Reykjavik (Iceland), Cork (Ireland) and Knowsley (England). The aim was to interview the parents of children with a range of Thylstrup and Fejerskov (TF) index grades selected from each participating centre with respect to the appearance of their child's permanent maxillary central incisors. Interviewers were blinded as to the TF grade of the subject. RESULTS: Interviews were conducted with parents of 215 children: 69 with TF grade 0; 70 with TF grade 1; 60 with TF grade 2 and 16 with TF grade 3 or greater. There was a trend towards more parents being unhappy with the appearance of their child's teeth with increasing TF grade. However, the main reasons given by parents for being unhappy with the appearance of their child's teeth was tooth alignment followed by the more yellow colour of permanent compared with primary teeth. Only with a TF grade of 3 was any appreciable concern expressed about fluorosis. CONCLUSION: It would appear that there is a public awareness of both developmental defects and enamel fluorosis although this is not always expressed as dissatisfaction. Further research is required into the clinical impact of both fluorosis and other developmental defects of enamel.

Development of a standardized method for comparing fluoride ingested from toothpaste by 1.5-3.5-year-old children in seven European countries. Part 1: Field work.

OBJECTIVES: To develop a standardized method for measuring the variables affecting fluoride ingestion from toothpaste in young children between the ages of 1.5 and 3.5 years, and to use the method at seven European sites. METHODS: Random samples of children were invited to take part in the study. Parents who gave consent were visited at home. The children brushed their teeth using the toothpaste brand and toothbrush type currently in use. Variables measured were: type of toothpaste used, fluoride concentration of toothpaste used, weight of toothpaste used, frequency of brushing and body weight of the child. RESULTS: It was not possible to follow the agreed protocol in all seven countries and in three countries appropriate alternative methods were employed. There was considerable variation between countries in the variables investigated. Use of children's toothpaste ranged from 69% in Ireland to 98% in Portugal. In the Netherlands up to 60% of the children were using toothpaste containing <400 ppm F and in Finland up to 27% of children were using toothpaste containing >1200 ppm F. Over half of the children used <0.25 g of toothpaste per brushing and the majority of children brushed once or twice per day. CONCLUSION: Although adherence to the agreed protocol was not possible at all study sites there was a clear picture of considerable variation in the oral hygiene practices of young children throughout Europe.

Development of a standardized method for comparing fluoride ingested from toothpaste by 1.5-3.5-year-old children in seven European countries. Part 2: Ingestion results.

OBJECTIVES: To develop a standardized method for measuring the variables affecting fluoride ingestion from toothpaste in young children between the ages of 1.5 and 3.5 years, and to use the method at seven European sites. METHODS: Random samples of children were invited to take part in the study. Parents who gave consent were visited at home. The children brushed their teeth using the toothpaste brand and toothbrush type currently in use. The difference between the fluoride dispensed onto the toothbrush and the fluoride recovered after accounting for losses was deemed to be the fluoride ingested. Details of other oral health-care habits were collected by questionnaire. For each child, the fluoride concentration of the toothpaste used was measured in the laboratory, from which an estimate of total daily fluoride ingestion was made. RESULTS: There was considerable variation between countries in the types of toothpaste used and in the amounts of toothpaste applied and ingested. The amount of fluoride ingested ranged from 0.01 to 0.04 mg fluoride per kg of body weight per day. CONCLUSION: The amount of fluoride ingested that is likely to be a risk factor for the development of dental fluorosis during tooth formation is equivocal and was found to vary widely between European countries. There appears to be a need for clearer health messages regarding the use of fluoridated toothpaste by young children.

Fluoride ingestion from toothpaste: fluoride recovered from the toothbrush, the expectorate and the after-brush rinses.

OBJECTIVES: The aim of this study was to determine the effects of rinsing and spitting on fluoride ingestion from toothpaste during normal oral-hygiene procedures of younger children, and hence to make recommendations on rinsing during toothbrushing. METHODS: The brushing habits of 166 Dutch and 185 Irish children between 1.5 and 3.5 years were observed during home visits. The weight of the toothpaste tube was determined before and after use. After brushing, the toothbrush and any associated expectorate and rinses, combined with any toothpaste spilled during the brushing procedures, were collected. The amounts of fluoride retained on the toothbrush and in the associated expectorate and rinses were measured. RESULTS: Over 90% of the Dutch children used a special toddlers' toothpaste with < or =500 ppm F. Eleven per cent of the younger (<2.5 years) Dutch children and 22% of the older children rinsed after brushing. Of the Irish children approximately 52% used a children's toothpaste containing around 500 ppm F. Of the younger Irish children 31% spat without rinsing, while another 31% rinsed during or after brushing. For the older Irish children, these percentages were 14 and 70%, respectively. On average, 22% of the fluoride dispensed on the toothbrush was retained on the brush after brushing irrespective of the rinsing and spitting behaviour of the children. The maximum ingestible amount of fluoride from toothpaste assuming no rinsing or spitting was calculated. CONCLUSIONS: Fluoride ingestion from toothpaste is significantly reduced by rinsing and/or spitting during toothbrushing. Recommendations that younger children use small amounts of toothpaste (< 0.5 g) and that children using toothpaste with > or = 1000 ppm F rinse their mouths after brushing continue to be valid.

Urinary fluoride excretion by preschool children in six European countries.

OBJECTIVE: To measure and compare 24-h urinary fluoride excretion in children aged 1.5-3.5 years from European study sites and to use these data to estimate the 24-h fluoride intake. METHOD: Twenty-four-hour urine samples were collected from 3-year-old children (n = 86) who were already participating in a European multicentre study. Samples were collected from Cork, Ireland (n = 19) where the water is fluoridated to a concentration between 0.8 and 1.0 ppm and from five sites with a water fluoride concentration <0.15 ppm: Knowsley, England (n = 18); Oulu, Finland (n = 18); Reykjavik, Iceland (n = 4); Haarlem, the Netherlands (n = 6); Almada/Setubal, Portugal (n = 21). The volume of the samples was measured; they were analysed for fluoride concentration and the 24-h urinary fluoride excretion was calculated. From this an estimate of the daily fluoride intake was made. RESULTS: It was found that the mean fluoride excretion in response to the usual conditions of fluoride intake in the children in the nonfluoridated areas ranged from 0.16 mg (+/-0.08) in Oulu to 0.33 mg (+/-0.27) in Almada/Setubal with an overall mean of 0.23 mg (+/-0.19). The mean 24-h fluoride excretion in fluoridated Cork was 0.37 mg (+/-0.11). There was a significant difference between the fluoride excretion in the nonfluoridated areas and that in the fluoridated areas, and the data were broadly in agreement with WHO standards. CONCLUSIONS: The daily urinary fluoride excretion and estimated fluoride intake in these children appeared to be within acceptable limits.