Caries prevention with fluoride toothpaste in children: an update.
Abstract: AIM: The aim was to examine recent literature and review the caries-preventive effect of fluoride toothpaste in children. METHODS: Based on three comprehensive systematic reviews published in 2003, a broad search of the PubMed and Cochrane library databases was conducted for papers published 2002-2008 using "fluoride toothpaste", "fluoride dentifrice" and "fluoride dental cream" as index terms. Relevant publications were identified after assessment of their abstracts. Papers were selected if they reported a prospective controlled design with caries data reported at baseline and at the end of the study. The targeted papers were critically assessed concerning design, methodology and performance according to a pre-determined checklist. RESULTS: The initial search revealed 179 papers of which 15 met the inclusion criteria. There was strong evidence that daily use of fluoride toothpaste has a significant caries-preventive effect in children compared with placebo (prevented fraction 24%). The effect was boosted by supervised tooth brushing, increased brushing frequency to twice daily, and use of a toothpaste concentration of 1,500 ppm fluoride. There were few studies of high quality reporting findings from the primary dentition. There were no studies available, and therefore insufficient evidence, on when to commence brushing with fluoride toothpaste as well as on the post-brushing behaviour. The use of "adult" toothpaste in very young children seemed to increase the risk for mild dental fluorosis in low-caries communities but not in socially deprived high-caries populations. CONCLUSIONS: The results reinforced the outstanding role of fluoride toothpaste as an effective caries preventive measure in children. Key words: caries, children, dentifrice, prevention
Article Type: Report
Subject: Dental caries (Prevention)
Fluorides (Usage)
Fluorides (Health aspects)
Dentifrices (Usage)
Dentifrices (Health aspects)
Evidence-based medicine (Evaluation)
Toothbrushing (Health aspects)
Author: Twetman, S.
Pub Date: 09/01/2009
Publication: Name: European Archives of Paediatric Dentistry Publisher: European Academy of Paediatric Dentistry Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2009 European Academy of Paediatric Dentistry ISSN: 1818-6300
Issue: Date: Sept, 2009 Source Volume: 10 Source Issue: 3
Product: Product Code: 2844420 Toothpaste NAICS Code: 325611 Soap and Other Detergent Manufacturing SIC Code: 2844 Toilet preparations
Accession Number: 227281634
Full Text: Introduction

There is a global consensus that regular use of fluoride (F) toothpaste constitutes a cornerstone in child dental health. In fact, a global survey revealed that most experts addressed F toothpaste as the main reason for the dramatic decline in caries during the last decades of the 20th century [Bratthall et al., 1996]. Furthermore, toothpaste is probably the most readily available form of F and tooth brushing is a convenient and approved habit in most cultures [Marinho, 2008]. Working groups within national Health Technology Agencies have independently and in parallel presented strong scientific evidence that daily tooth brushing with F toothpaste is the most cost-effective self-applied method to prevent caries at practically all ages [Marinho et al., 2003; Twetman et al., 2003].

In evidence-based medicine, strong scientific evidence means that the conclusion is supported by several randomised controlled trials of high study quality and relevance, and with a low probability of bias and confounding factors. In addition, no major study should report a conflicting outcome. Thus, it is very unlikely that further research on the topic will challenge such a conclusion with strong evidence. Yet there are still questions to be answered concerning the use of F toothpaste in children, such as the optimal concentrations at various ages and from what age F toothpaste should be introduced. The aim of the present paper was to examine the body of evidence concerning caries-preventive efficacy of F toothpaste in children based on existing systematic reviews and an updated literature search in order to form a basis for development of evidence-based clinical guidelines.

Methods

A search for systematic reviews on the topic was carried out in the PubMed database and Cochrane library from 2001 through to October 2008. This initial search displayed 25 papers of which 3 systematic reviews and 3 meta-analyses were selected (Table 1). In addition, a broad search for randomised controlled trials published between 2002 and 2008 was performed using the same Mesh-terms as in a previous systematic review [Twetman et al., 2003], the principal being "fluoride toothpaste", "fluoride dentifrice" and "fluoride dental cream". The 6-year time span was chosen to secure an overlap with the identified systematic reviews. Only original papers with at least a full abstract in English were accepted while sole abstracts, grey literature and textbooks were discarded.

The cut-off criteria for inclusion were a prospective randomised or quasi-randomised controlled design performed in children or in adolescents. Both baseline and endpoints caries data were requested. Studies comparing different toothpaste formulas but with identical concentrations of fluoride were not taken into account. The reference lists of the included literature were hand-searched for additional articles. From a starting point of 179 articles, 15 papers met the inclusion criteria and those papers were critically appraised by the author with respect to design, methodology and performance according to a predetermined check-list [Twetman et al., 2003]. The quality of evidence from each study was graded as high (A), medium (B) or low (C) as previously described [Twetman et al., 2003]. The main outcome measure was prevented fraction (PF) calculated as the difference in mean caries increment between the intervention and control groups expressed as percentage of the increment in the control group.

Results and discussion

Caries preventive effect of fluoride toothpaste versus placebo. The selected systematic reviews and meta-analyses are presented in Table 1. The prevented fraction was 24-25% in the two most comprehensive reviews to date [Marinho et al., 2003; Twetman et al., 2003]. The number needed to treat (NNT) varied with the level of disease in the population and was most favourable (1.6) in communities with a high level of the disease [Marinho et al., 2003]. This means that almost two children must use F toothpaste over the study period in order to avoid one lesion. The absolute mean caries reduction was 0.6 surfaces per year in a population with an average caries increment of around 2.5 decayed, missing and filled surfaces (DMFS) per year [Marinho, 2003]. In populations with a lower caries increment, NNT increased to 3.7 and the annual saving decreased to 0.3 DMFS in the permanent dentition. It is worthwhile to emphasise that the Cochrane reviews concluded that F toothpaste could reduce dental caries regardless of water fluoridation or other sources of F exposure [Marinho, 2008].

The selected clinical trials published between 2002 and 2008 were compiled in Tables 2 and 3. In Table 2, studies evaluating F toothpaste versus placebo or no intervention were listed. The papers exhibited varying quality and differed with respect to sample size, age of study groups, method of allocation and duration; consequently, they displayed highly varying results (PF 11-54%). The quality of evidence of the 10 papers was graded as medium or low, most of them being "C". However, from an evidence-based point of view the important thing was that all recent studies pointed in the same direction and presented findings in favour of F toothpaste. In fact, the mean value of the prevented fraction was 25% and therefore more or less identical to the findings of previous systematic reviews [Marinho et al., 2003; Twetman et al., 2003].

Many of the recent trials were field studies conducted in deprived communities with a low background F exposure. The fact that tooth brushing was a part of an oral health education program in some of the studies does not allow firm conclusions concerning the efficacy of F toothpaste. It must also be noted that many of the projects suffered from large attrition rates and that placebo toothpaste only was used in three studies [You et al., 2002; Biesbrock et al., 2003a; Biesbrock et al., 2003b]. This was a concern, because studies with control groups without brushing may overestimate the caries preventive effect. Another notable trend was that "adult" toothpaste with around 1,000 ppm fluoride was used also in the trials with toddlers and young pre-school children with a mean prevented fraction of 34% [Davies et al., 2002; You et al., 2002; Rong et al., 2003]. However, as these studies were assessed with a "C", there is still a need for high quality trials on the effect of F toothpaste in the primary dentition.

Influence of fluoride concentration. Within the European Union, the upper limit of F in over-the-counter products is 1,500 ppm and most consumer brands range from 1,000 to 1,450 ppm F. For children, special low-F toothpastes (<500 ppm F) are available in some countries. The systematic reviews presented a broad body of evidence of a dose-response relationship between the prevented fraction and F concentration in the toothpaste that means the higher the concentration the better [Ammari et al., 2003; Twetman et al., 2003]. At the same time, there is inconclusive or insufficient evidence for a caries-preventive effect of toothpastes with less than 500 ppm F [Twetman et al., 2003; Steiner et al., 2004].

A maybe more intriguing and interesting question is whether or not there is evidence for the use of toothpaste with higher F content than 1,500 ppm F, especially for young children. Earlier studies have suggested that within the range of 1,000-2,800 ppm F, an increase of around 500 ppm results in an additional reduction in dental caries [Stephen et al., 1988; O'Mullane et al., 1997]. Likewise, Marinho et al. [2003] reported a "just non-significant association between increased prevented fraction and fluoride concentration (p=0.051)" with an 8% increase in PF per 1,000 ppm F (95% CI: -315%). The benefit versus risk aspects of the use of high F toothpastes must however be considered. For high caries risk children in deprived communities the benefits may outweigh the risk while the opposite may be the case for young children with low caries risk.

The search for recent dose-response trials with coronal caries as endpoint identified 5 articles that are summarized in Table 3. The quality of evidence from these articles was mixed but one of them was assessed as being of high quality [Chesters et al., 2002]. A notable, albeit expected, fact was that all but one [Lima et al., 2008] was funded and conducted by, or in close cooperation with, the industry. Three out of four studies reported a superior caries preventive effect from toothpastes containing 2,500-2,800 ppm F as compared with 1,100 ppm formulas.

The previous conclusion of an inferior caries-preventive effect by low F toothpaste was challenged by the studies of Biesbrock et al., [2003a] and Stookey et al., [2004a] while it was reinforced by Davies and co-workers [2002] and by the meta-analysis of Steiner et al., [2004]. Thus, the evidence for low F toothpastes is therefore still to be regarded as inconclusive. There were no recent studies available on toothpastes containing more than 2,800 ppm F in children and adolescents. This was notable in the light of the present marketing activities of a high-end toothpaste containing 5,000 ppm Fe in some European countries. The high-F toothpaste is available on prescription only and intended for caries-active individuals over 16 years and patients with special needs, such as dry-mouth and frail elderly as well as adolescents with fixed orthodontic appliances.

Supervised versus. non-supervised use of fluoride toothpaste and frequency of tooth brushing. Based on the existing literature, it seems clear that the caries-preventive effect of supervised tooth brushing with F toothpaste in school settings is superior (11% PF) to non-supervised home use [Chaves and Vieira-da-Silva, 2002; Twetman et al., 2003; Marinho et al., 2003]. The majority of the recent trials listed in Table 2 utilized supervised school-brushing as they were conducted in socially deprived high-caries communities or as part of a comprehensive oral health program. Another factor of importance for the anti-caries effect is the frequency of brushing. A number of earlier clinical trials have reported an association between reported brushing frequency and caries incidence. Consequently, the systematic review by Marinho et al., [2003] displayed a 14% increase in prevented fraction by moving from tooth brushing once to twice a day with a given concentration.

When to start with fluoride toothpaste? Although there are cross-sectional and observational studies that claim an association between the age of commencing tooth brushing and caries experience [Verrips et al., 1992: Davies et al., 2003; Declerck et al., 2008; Warren et al., 2008], no prospective study of good quality, designed to answer the abovementioned question, was identified in the present search. Thus, any clinical recommendations on when to commence with F toothpaste seem to be based on indirect evidence. Some additional information could however be extracted from longitudinal studies with the aim to identify risk factors for caries development in toddlers and preschool children [Wendt et al., 1996; Levy et al., 2003, Mattila et al., 2005]. For example, Wendt et al., [1996] showed that 1-year-olds that had their teeth brushed with F toothpaste at least once daily had a three times greater chance to remain caries-free at the age of 3 years. Interestingly, a long-term follow-up of the very same material displayed that the children with early parental help were also less susceptible for proximal caries in their permanent dentition [Alm et al., 2008].

Post-brushing rinsing. The post-brushing behaviour has gained some interest in the earlier literature [Chesters et al., 1992; Sjogren et al., 1995; Chestnutt et al., 1998] and it is generally advocated that children should be encouraged to spit out excess toothpaste and avoid rinsing with water. The above-mentioned papers were however assessed with significant confounders and/or bias [Twetman et al., 2003] and more recent data are sparse. Machiulskiene and co-workers [2002] compared the effect of post-brushing behaviour on dental caries increment in 10-12 year-old schoolchildren from two different schools. The tooth brushing procedure was supervised and the children in one school were instructed to rinse thoroughly with a beaker of water whereas the children in the other school only were permitted to spit out once after brushing. No significant differences in caries increment were displayed after 3 years although a better compliance was noted with the spit-out regimen. The study was graded as "C" in quality and therefore, the evidence concerning post-brushing rinsing is still regarded as insufficient. In this context, the findings of a report examining F concentrations in unstimulated saliva and dental plaque after tooth brushing with F toothpaste and different post-brush rinsing protocols were of interest [Heijnsbroek et al., 2006]. The authors demonstrated that increased salivary F concentrations were not reflected in newly formed dental plaque which illustrates that multiple and complex variables are involved in the individual fluoride retention.

Side effects. No immediate harmful effects or adverse events following the use of F toothpaste were reported in the selected trials. However, it is generally considered that the use of F toothpaste in very young children is a potential risk factor for dental fluorosis [Mascarenhas and Burt, 1998]. Evidently, F toothpaste may be responsible for up to 80% of the daily F intake [de Almeida et al., 2007] and the first 3 years of life seem to be most critical and the risk of fluorosis is related to the dose ingested which is a function of both the amount of toothpaste ingested and its F concentration. The literature around this issue is vast and beyond the scoop of this paper.

However, it was of interest to examine findings on the prevalence of dental fluorosis in connection with one of the appraised toothpaste trials. After completion of the "free fluoride toothpaste" project by Davies et al., [2002a], the research group conducted a follow-up with respect to the prevalence and severity of fluorosis in the maxillary permanent incisors [Tavener et al., 2004]. The provision of either 440 or 1,450 ppm F toothpaste from 12 months of age did not have a significant impact on the prevalence of fluorosis in the most deprived districts. However, in less deprived low-caries communities however, a slight increase in the prevalence of very mild form of fluorosis was registered [Tavener et al., 2006]. This was mainly explained by a generally lower compliance with the intervention program among the most vulnerable groups. The prevalence of the TF fluorosis score >3 was 2.2% in the high F toothpaste group compared with 0.4% for the low F group. This author's conclusion was therefore that high F toothpastes might not be indicated for community programmes in less deprived low-caries communities.

Experiences from Australia have shown that introduction of low F toothpaste (400-550 ppm F) and use of smaller amount of toothpaste restricted the risk of fluorosis in association with early toothpaste use [Do and Spencer, 2007]. Thus, evaluation of the risk-benefit balance is a true pivot point in the formulation of appropriate guidelines concerning F toothpaste use in infants and toddlers. It is important to stress the fact that the background F exposure as well as the socioeconomic level of the community must influence any recommendations.

Conclusions

There is strong evidence that daily use of fluoride toothpaste has a significant caries-preventive effect in children compared with placebo or no brushing. The effect is boosted by supervised tooth brushing, increased frequency to twice daily brushing and the use of toothpastes containing around 1,500 ppm fluoride. There were still few studies of high quality performed in the primary dentition and the evidence for different post-brushing behaviours were inconclusive. There were no studies available and thus, insufficient evidence on when to commence brushing with fluoride toothpaste or for the use of the 5,000 ppm fluoride toothpaste in school children and adolescents.

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S. Twetman,

Dept. of Cariology and Endodontics, Faculty of Health Sciences, University of Copenhagen, Denmark

Postal address: Prof. S. Twetman., Department of Cariology and Endodontics, Faculty of Health Sciences, University of Copenhagen, N0rre Alle 20, DK-2200 Copenhagen N, Denmark

Email: stw@odont.ku.dk
Table 1. Prevented fraction of fluoridated toothpaste (FTP) in
recent systematic reviews (SR) and meta-analyses (MA). PF =
prevented fraction; CI = confidence interval

First author, (year)           Type of          Included
                             publication       studies (n)

Ammari, et al., [2003]           SR                 6
Marinho, et al., [2003]          SR                70
Twetman, et al., [2003]          SR                26
Bartizek, et al.,[2001]          MA                6a
Chaves, et al., [2002]           MA                22
Steiner, et al., [2004]          MA                 4

First author, (year)             Comparison         PF% (95% CI)

Ammari, et al., [2003]     1,000 ppm vs. 250 ppm      13 (5-20)
Marinho, et al., [2003]       FTP vs. placebo        24 (21-28)
Twetman, et al., [2003]       FTP vs. placebo        25 (20-28)
Bartizek, et al.,[2001]      2800 vs. 1,100 ppm           8
Chaves, et al., [2002]        FTP vs. placebo            29
Steiner, et al., [2004]    1,000 ppm vs. 250 ppm         13

(a) Four of the studies were unpublished "data on file"

Table 2. Major randomised controlled trials concerning the
caries-preventive effect of fluoride toothpaste vs. no toothpaste or
placebo in children published after the most recent systematic
reviews.

First author, yr                    age, yr             n

Al-Jundi, et al., [2006]             6, 12             856
Biesbrock, et al., [ 2003a]           9-12             657
Biesbrock, et al., [2003b]            9-12             432
Curnow, et al., [2002]                 5               534
Davies, et al., [ 2002]                1              4,950
Davies, et al., [2003]                 1              4,934
Jackson, et al., [2005]               5-6              517
Machiulskiene, et al., [2002]        10-12             407
Madlena, et al., [2002]              14-16             394
Rong, [2003]                           3               731
You, [2002]                            3              1,334

First author, yr                   duration,         drop-out
                                     months

Al-Jundi, et al., [2006]               48               6%
Biesbrock, et al., [ 2003a]            9                6%
Biesbrock, et al., [2003b]             9                7%
Curnow, et al., [2002]                 24              14%
Davies, et al., [ 2002]              48-60             50%
Davies, et al., [2003]               48-60             50%
Jackson, et al., [2005]                24              28%
Machiulskiene, et al., [2002]          36              32%
Madlena, et al., [2002]                24              30%
Rong, [2003]                           24              29%
You, [2002]                            24              31%

First author, yr                  intervention         type
                                     ppm F

Al-Jundi, et al., [2006]           1,000/500           SVa
Biesbrock, et al., [ 2003a]        1,450/500            SV
Biesbrock, et al., [2003b]           1,100              SV
Curnow, et al., [2002]               1,000              SV
Davies, et al., [ 2002]              1,440              --
Davies, et al., [2003]                440               --
Jackson, et al., [2005]              1,450              SV
Machiulskiene, et al., [2002]        1,500              SV
Madlena, et al., [2002]              1,400              --
Rong, [2003]                         1,100            SV (a)
You, [2002]                          1,100            SV (a)

First author, yr                    control          PF% (LE)

Al-Jundi, et al., [2006]              none        13/15 (b) (B)
Biesbrock, et al., [ 2003a]         placebo         54/53 (B)
Biesbrock, et al., [2003b]          placebo         53 (c) (B)
Curnow, et al., [2002]                none          32 (d) (B)
Davies, et al., [ 2002]               none            15 (C)
Davies, et al., [2003]                none          4, NS (C)
Jackson, et al., [2005]               none            10 (C)
Machiulskiene, et al., [2002]         none          38 (e) (C)
Madlena, et al., [2002]               none            10 (C)
Rong, [2003]                          none            31 (C)
You, [2002]                         placebo           21 (C)

(a) tooth brushing part of an oral health program; (b) two different
age cohorts; (c) median value of three examiners; (d) first
permanent molars; (e) cavitated stages only.

PF = prevented fraction (DMFT/dmft, DMFS/dmfs); LE = level of
evidence A-C; SV = supervised tooth brushing (daily or on
schooldays); NS = not statistically significant.

Table 3. Major randomised controlled trials concerning the
caries-preventive effect of toothpaste with high or low content of
fluoride vs. conventional or low-fluoride toothpaste in children
published after the most recent systematic reviews

First author, yr   age, yr     n     duration,   drop-out
                                      months

Biesbrock,          9-12      437        9          9%
et al., [ 2003a]

Biesbrock,          9-12      321        9          7%
et al., [2003b]

Chesters,           11-14    2,387      12          7%
et al., [2002]

Davies,               1      4,960     48-60       50%
et al., [2002]

Lima,                2-4      43        12         25%
et al., [2008]

Stookey,            9-12      482       24         28%
et al., [2004]

Stookey,            9-12      575       24         28%
et al., [2004]

First author, yr   intervention   type   control    PF% (LE)
                      ppm F

Biesbrock,            1,450        SV      500     0, NS (B)
et al., [ 2003a]

Biesbrock,            2,800        SV     1,100    4a, NS (B)
et al., [2003b]

Chesters,             2,500        SV     1,000      9b (A)
et al., [2002]

Davies,               1,450        --      440       11 (C)
et al., [2002]

Lima,                  500         SV     1,100     50c (C)
et al., [2008]

Stookey,               500         SV     1,100    0/11d, NS
et al., [2004]                                        (B)

Stookey,              2,800        SV     1,100    13/23d (B)
et al., [2004]

(a) median value of three examiners; (b) all lesions included;
(c) caries-active children only; (d) results of two different
examiners. PF = prevented fraction (DMFT-dmfs, DMFS-dmfs); LE = level
of evidence A-C; SV = supervised tooth brushing (daily or on school
days); NS = not statistically significant.
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