Plain language summary
Fluorides for the prevention of early tooth decay (demineralised white lesions) during fixed brace treatment
Ugly white marks sometimes appear on the teeth during orthodontic (brace) treatment. These are caused by early tooth decay and usually occur with fixed (or glued-on 'train track') braces when the teeth are not cleaned properly.
We know that fluoride in toothpaste helps to prevent dental decay; therefore, extra fluoride provided to people wearing braces should protect them from these marks. This review, produced by the Cochrane Oral Health Group, examines the evidence for this in existing research. The aim of this review is to assess the effectiveness of fluorides in preventing early tooth decay during orthodontic (brace) treatment and to determine the best way to do this.
Early tooth decay around the brackets that attach braces to the teeth can cause white or brown marks (demineralised white lesions (DWLs)) to appear on teeth during fixed brace treatment. Build-up of dental plaque around these brackets is associated with increased risk of rapid demineralisation of the enamel of teeth. Demineralisation is an early, but reversible, stage in the development of tooth decay. Wearing of fixed braces may be associated with pain, and both the brace and the pain make toothbrushing more difficult, which in turn means that it is harder to prevent the build-up of plaque. People often wear braces for 18 months or longer, and there is a risk that tooth decay will damage the teeth, requiring restorations and fillings to be done.
Fluoride is effective in reducing tooth decay in people who are at risk of developing it. Individuals receiving orthodontic treatment may be prescribed various forms of fluoride treatment. It is important to consider how the fluoride is to be applied and whether children and adolescents (receiving fixed brace treatment) are likely to be willing and able to regularly apply by themselves the amounts needed to prevent early tooth decay.
The evidence on which this review is based was up-to-date as of 31 January 2013. Three studies with 458 participants were included in this updated review. Participants were undergoing orthodontic treatment with fixed braces, and DWLs were assessed on teeth remaining in the mouth at the end of orthodontic treatment.
The different ways of applying fluoride that were assessed included:
1. topical fluorides, for example, fluoride-containing varnish, mouthrinse, gel or toothpaste;
2. fluoride-releasing devices attached to the braces; and
3. control group approaches - individuals did not receive additional fluoride as described, or they received a placebo or a different form of fluoride.
One study showed that when the dentist paints fluoride-containing varnish around the teeth and brace every time it is adjusted, the risk of developing white marks is reduced by nearly 70%; however, further well-designed trials are required to confirm this finding.
The rest of the evidence is weak, and more studies are needed to show the best way of delivering extra fluoride to people wearing braces. Adverse effects or harms of interventions were not reported in any of the included studies.
Quality of the evidence
The quality of the evidence found is moderate in the case of one well-designed study and weak in the remaining studies. Recommendations state that further well-conducted research should be conducted in this area.
Fluorures dans la prévention des caries précoce (lésions blanches déminéralisées) pendant un traitement avec un appareil dentaire fixe
Question de la revue
Des marques blanches déplaisantes apparaissent parfois sur les dents au cours d’un traitement orthodontique (appareil dentaire). Elles sont causées par une carie dentaire précoce et surviennent généralement avec des appareils dentaires fixes (ou collés) lorsque les dents ne sont pas correctement nettoyées.
Nous savons que le fluorure dans le dentifrice aide à prévenir la formation de caries dentaires; par conséquent, un supplément en fluorure chez les patients portant un appareil dentaire fixe devrait les protéger de ces taches. Cette revue, produite par le groupe Cochrane sur la santé bucco-dentaire, examine les preuves dans les recherches existantes. L'objectif de cette revue est d'évaluer l'efficacité des fluorures dans la prévention des caries précoces pendant le traitement orthodontique (appareil dentaire) et de déterminer la meilleure façon de l’effectuer.
La carie dentaire précoce autour des supports qui relient les bagues aux dents peut provoquer des taches blanches ou brunes (lésions blanches déminéralisées) sur les dents pendant un traitement avec un appareil fixe. L’accumulation de plaque dentaire autour de ces supports est associée à un risque accru de déminéralisation rapide de l'émail des dents. La déminéralisation est un stade précoce, mais réversible, dans le développement de caries. Le port d'un appareil orthodontique fixe peut être associé à de la douleur, ce qui ne facilite pas le brossage des dents et il est donc plus difficile de prévenir l'accumulation de plaque dentaire. Les personnes portent souvent un appareil dentaire pendant une durée de 18 mois ou plus et les caries dentaires peuvent abimer les dents, des obturations et des plombages seront donc nécessaires.
Le fluorure est efficace pour réduire la carie dentaire chez les personnes qui risquent de la développer. Les personnes recevant un traitement orthodontique peuvent être prescrites diverses formes de traitement au fluorure. Il est important de tenir compte de la façon dont le fluorure doit être appliqué et si les enfants et les adolescents (recevant un traitement avec un appareil fixe) sont enclins et capables d’appliquer régulièrement les quantités nécessaires par eux-mêmes pour prévenir la formation précoce de caries dentaires.
Les caractéristiques de l'étude
Les preuves sur lesquelles cette revue est basée ont été actualisées le 31 janvier 2013. Trois études totalisant 458 participants ont été inclues dans cette revue mise à jour. Les participants subissaient un traitement orthodontique avec un appareil fixe et les lésions blanches déminéralisées ont été évaluées sur les dents restantes à la fin du traitement orthodontique.
Différentes méthodes d'applications de fluorure qui ont été évaluées incluaient:
1. La fluoration, par exemple, du vernis, un bain de bouche, du gel ou du dentifrice contenant du fluor
2. Du fluor fixé sur les attelles;
3. Différentes approches des groupe de contrôle - les personnes n'avaient pas reçu de fluorure comme décrit, ou avaient reçu un placebo ou une autre forme de fluorure.
Une étude a montré que lorsque le dentiste vernit le contour de la dent et l’appareil dentaire au fluorure et à chaque ajustage, le risque de développer des taches blanches est réduit de presque 70%; toutefois, d'autres essais bien conçus sont nécessaires pour confirmer ce résultat.
Le reste des preuves est faible et des études supplémentaires sont nécessaires pour établir la meilleure façon d'administrer un supplément de fluorure à des personnes portant un appareil dentaire fixe. Les effets indésirables ou les inconvénients des interventions n'étaient rapportés dans aucune des études incluses.
Qualité des preuves
Les preuves identifiées sont de qualité modérée dans le cas d'une étude bien planifiée et faibles dans les études restantes. Les recommandations indiquent que d'autres recherches bien réalisées devraient être menées dans ce domaine.
Notes de traduction
Traduit par: French Cochrane Centre 14th January, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé
Ringkasan bahasa mudah
Fluorida untuk pencegahan awal kerosakan gigi (lesi putih ternyahmineral) semasa rawatan pendakap tetap
Tompok-tompok putih yang hodoh kadangkala terbentuk semasa rawatan ortodontik (pendakap). Ia disebabkan oleh kerosakan gigi awal dan sering terbentuk dengan penggunaan pendakap apabila gigi tidak dibersihkan dengan teliti
Kita telah maklum bahawa fluorida dalam ubat gigi membantu mencegah kerosakan gigi; lebihan bekalan fluorida bagi mereka yang memakai pendakap sepatutnya dapat melindungi kejadian tompok-tompok tersebut. Tinjauan yang dihasilkan oleh Kumpulan Kesihatan Oral Cochrane memeriksa bukti ini dalam penyelidikan sedia ada. Tinjauan ini bertujuan menilai keberkesanan fluorida dalam pencegahan awal kerosakan gigi semasa rawatan ortodontik (pendakap) dan menentukan cara pencegahan terbaik.
Kerosakan awal di sekitar braket yang melekatkan pendakap kepada gigi boleh menyebabkan tompok putih atau perang (lesi putih ternyahmineral (LPT)) terbentuk pada gigi semasa rawatan pendakap tetap. Pengumpulan plak gigi di sekitar braket dikaitkan dengan peningkatan risiko enamel gigi ternyahmineral yang pesat. Demineralisasi adalah peringkat awal dalam kejadian kerosakan gigi yang boleh dipulihkan. Pemakaian pendakap tetap boleh dikaitkan dengan rasa sakit, dan kedua-dua pendakap dan rasa sakit menyukarkan memberus gigi dan seterusnya lebih sukar untuk menghalang pengumpulan plak. Kebanyakan orang memakai pendakap untuk tempoh 18 bulan atau lebih, dan risiko kerosakan gigi akan memusnahkan gigi dan memerlukan restorasi dan tampalan.
Fluorida berkesan mengurangkan kerosakan gigi dalam kalangan orang yang berisiko. Individu yang menerima rawatan ortodontik boleh diberi pelbagai bentuk rawatan fluorida. Adalah penting untuk membuat pertimbangan bagaimana fluorida perlu diaplikasi dan sama ada kanak-kanak dan remaja (yang menerima rawatan pendakap) sanggup dan mampu untuk mengaplikasi sendiri amaun yang perlu untuk pencegahan awal kerosakan gigi.
Sorotan ini berdasarkan bukti sehingga 31 Januari 2013. Tiga kajian yang melibatkan 458 peserta dimasukkan dalam sorotan ini yang telah dikemaskini. Gigi peserta-peserta yang menerima rawatan ortodontik dengan pendakap tetap dan DWLs dikaji di akhir rawatan ortodontik.
Pelbagai cara aplikasi fluorida yang dinilai termasuk:
1. Fluorida topikal seperti varnis berfluorida, ubat kumur mulut, gel atau ubat gigi;
2. Peranti mengeluarkan fluorida yang terlekat kepada pendakap;
3. Pendekatan kumpulan kontrol – individu menerima plasebo atau lain-lain bentuk fluorida, atau tidak menerima fluorida tambahan seperti yang tersebut.
Satu kajian menunjukkan apabila doktor gigi mengaplikasi varnis berfluorida pada gigi dan pendakap setiap kali rawatan, risiko pembentukan LPT berkurang hampir 70%; namun rekabentuk kajian yang baik diperlukan untuk mengesahkan keputusan ini.
Bukti selebihnya adalah lemah, dan lebih banyak kajian diperlukan untuk mengenalpasti cara terbaik membekalkan fluorida tambahan kepada orang yang memakai pendakap gigi. Kesan sampingan atau bahaya intervensi tidak dilaporkan dalam mana-mana kajian yang disertakan.
Kualiti bukti yang didapati adalah sederhana dalam satu rekabentuk kajian yang baik dan lemah dalam kajian selebihnya. Dicadangkan lebih banyak penyelidikan yang baik patut dibuat dalam aspek ini.
Diterjemahkan oleh Noorliza Mastura Ismail (Melaka-Manipal Medical College). Disunting oleh Lai Nai Ming ( School of Medicine, Taylor's University Malaysia) Untuk sebarang pertanyaan berkaitan terjemahan ini sila hubungi email@example.com
Fluoridi za sprječavanje ranog karijesa (demineralizirane bijele lezije) za vrijeme liječenja fiksnim zubnim aparatićem
Tijekom ortodontske terapije ponekad se na zubima javljaju neugledne bijele mrlje. One su uzrokovane ranim propadanjem zubi i uobičajeno se pojavljuju na nepravilno čišćenim zubima u pacijenata s fiksnim aparatićem.
Znamo da fluoridi u zubnim pastama pomažu u sprječavanju nastanka karijesa; stoga bi dodatne količine fluorida trebale zaštiti ljude s fiksnim aparatićima od pojavljivanja bijelih mrlja. Ovaj pregled, pripremljen u okviru Cochrane uredničke skupine za oralno zdravlje (engl. Cochrane Oral Health Group), analizira postoje li dokazi koji bi potvrdili te tvrdnje u postojećim istraživanjima. Cilj ovog sustavnog pregleda je bio procijeniti učinkovitost fluorida u sprječavanju ranog zubnog karijesa za vrijeme ortodontskog liječenja i odrediti najbolji način za postizanje zaštite.
Rani zubni karijes u blizini nosača koji pričvršćuju aparatić za zube može uzrokovati pojavljivanje bijelih ili smeđih mrlja na zubima za vrijeme tretmana fiksnim aparatićem. Rast dentalnoga plaka oko tih nosača povezan je s povećanim rizikom od brze demineralizacije zubne cakline. Demineralizacija je rani, ali reverzibilan (povratni) stadij u razvoju zubnog karijesa. Nošenje fiksnih aparatića može biti izazivati bol, pa i aparatić i bol otežavaju pranje zubi, što zapravo znači da je teže spriječiti rast i razvoj zubnoga plaka. Ljudi uobičajeno nose aparatiće 18 mjeseci ili dulje, i postoji rizik da će karijes oštetiti zub, što zahtijeva restauraciju zuba i stavljanje ispuna.
Fluor je učinkovit u smanjenju zubnoga karijesa u ljudi s povećanim rizikom za njegov razvoj. Pacijentima se tijekom ortodontskog liječenja mogu propisati različite forme fluorne terapije. Važno je razmotriti kako će fluor biti primijenjen i hoće li djeca i adolescenti biti voljni i u mogućnosti redovno uzimati količine potrebne da bi se spriječila rana pojava zubnoga karijesa.
Ovaj sustavni pregled temelji se na dokazima objavljenim do 31. siječnja 2013. Uključio je tri istraživanja s 458 sudionika (ovo je obnovljeni sustavni pregled). Sudionici su bili podvrgnuti ortodontskom liječenju s fiksnim aparatom te su demineralizirane bijele lezije bile vidljive na zubima nakon ortodontskog liječenja.
Metode nanošenja fluorida koje su bile testirane:
1. Lokalni fluoridi, na primjer lakovi koji sadrže fluorid, vodica za ispiranje, gel ili pasta za zube;
2. Uređaji koji otpuštaju fluorid, pričvršćeni za fiksni aparatić; te
3. Kontrolna skupina – pojedinci nisu dobivali dodatni fluorid kao što je opisano, ili su dobivali placebo ili drugi oblik fluorida.
Jedno istraživanje je pokazalo da svaki puta kada stomatolog nanese lak koji sadrži fluorid oko zuba i fiksnog aparatića odnosno svaki puta kada se zategne, rizik od razvitka bijelih tragova se smanji za približno 70%. No, potrebna su daljnja pažljivo osmišljena istraživanja koja bi potvrdila taj zaključak.
Ostatak dokaza je slab te je potrebno više istraživanja koja bi pokazala najbolje načine za primjenu fluorida ljudima koje nose fiksne aparatiće. Ni jedan štetan učinak nije zabilježen niti u jednom od navedenih istraživanja.
Kvaliteta pronađenih dokaza je osrednja u slučaju jednog dobro provedenog istraživanja te slaba u preostalim istraživanjima. Preporučuju se daljnja bolje provedena u tom području.
Preveo: Luka Lerotić
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: firstname.lastname@example.org
Description of the condition
During orthodontic treatment with fixed appliances, brackets are attached to the teeth to hold the wires that provide the forces required to straighten the teeth. One of the adverse effects of fixed braces is that dental plaque collects around the attachments, leading to accumulation of the types of bacteria that cause dental disease (Naranjo 2006). Build-up of dental plaque around orthodontic brackets is associated with increased risk of demineralised white lesions (DWLs), which can be visible within six months (Tufekci 2011). Demineralisation is an early, but reversible, stage in the development of dental decay (caries). Cariogenic bacteria present in the dental plaque transform sugar in the diet into organic acids, which start to damage the tooth enamel. Effective removal of plaque will prevent DWLs from occurring; however, the presence of orthodontic appliances in the mouth and associated dental pain may make it more difficult for individuals to adequately clean their teeth and braces. DWLs developing on the buccal surfaces of teeth during orthodontic treatment can become a significant problem over the course of treatment, which may last for 18 months or longer, resulting in a poor appearance of the teeth following straightening (Maxfield 2012). In severe cases, caries can develop, requiring restoration (filling); this may be both painful and costly.
A recent study by Enaia and colleagues (Enaia 2011) using clinical photographs of the teeth taken before and after fixed brace treatment found that the prevalence of DWLs was 32% in participants before treatment; however, this proportion rose to 74% after treatment. Most of the DWLs were minor, but a significant minority of participants (10%) had cavities in their teeth, which may have required a filling. Although DWLs tend to fade with time as they heal, Ogaard 1989 found that, even five years after treatment, orthodontic participants had a significantly higher incidence of DWLs than a control group of participants who did not undergo orthodontic treatment.
Description of the intervention
Orthodontists are keen to prevent the development of DWLs so their patients may have the best possible outcome following orthodontic treatment - well-aligned caries-free teeth. Fluoride is important in the prevention of dental decay (ten Cate 2013). Marinho and colleagues (Marinho 2003) found a definite reduction in caries in children and adolescents who performed regular supervised rinsing with a fluoride mouthwash. It has also been shown that fluoride may reduce the number of DWLs that develop during brace treatment. When orthodontic participants used a mouthrinse, Geiger et al (Geiger 1992) found a 30% reduction in the number of participants and a 25% reduction in the incidence of teeth affected by DWLs. Many orthodontists recommend the use of a daily fluoride mouthrinse throughout brace treatment to prevent DWLs (Kerbusch 2012).
Several methods (in addition to fluoridated toothpaste) are used to deliver fluoride to teeth in patients during orthodontic treatment. These include the following.
Topical fluorides (e.g. mouthrinse, gel, varnish).
Fluoride-releasing materials (e.g. glues used to bond the brackets onto the teeth and orthodontic elastics that are impregnated with fluoride).
Dietary fluoride supplementation (e.g. fluoridated milk).
How the intervention might work
Fluoride present in the mouth reduces caries development via three mechanisms: inhibition of the demineralisation of dental enamel, enhancement of the remineralisation of dental enamel producing a remineralised layer that is resistant to acid attack and inhibition of the bacterial enzymes that produce the acid (Lynch 2006; ten Cate 2013).
Most children undergoing orthodontic treatment will be exposed to some fluoride - low concentrations in the water supply, higher concentrations from fluoridated dentifrices (toothpaste), or both. Use of additional topical fluorides and/or fluoride sources designed to deliver additional fluoride to the at-risk area near orthodontic brackets are likely to reduce the risk of DWL development. Topical fluorides include fluoride mouthrinses, varnishes, gels, dentifrices and dietary sources (e.g. fluoridated milk). Specific orthodontic sources of fluoride include bracket adhesives and orthodontic elastic bands (elastomeric ligatures), which slowly release fluoride into the mouth. All of these fluoride sources release fluoride into saliva that is distributed throughout the mouth.
Why it is important to do this review
Several systematic reviews have investigated the effects of delivering fluoride in various modes on dental caries in children and adolescents (Marinho 2003; Marinho 2003a; Marinho 2003b; Marinho 2004); however, these systematic reviews did not examine the effects of fluoride on participants wearing fixed orthodontic braces.
Some orthodontists routinely recommend to their patients the use of fluoride mouthrinses. However, clear evidence is lacking regarding the optimum concentration of fluoride in mouthrinses, the optimum frequency of mouthrinse use and the effects of mouthrinses and other topical fluorides over the duration of orthodontic treatment.
This is an update of a Cochrane review first published in 2004 to summarise evidence of the effects of the use of any topical fluoride on the prevention of demineralised white lesions in patients undergoing orthodontic treatment.
The primary objective of this review was to evaluate the effects of fluoride in reducing the incidence of demineralised white lesions (DWLs) on the teeth during orthodontic treatment.
The secondary objectives were to examine the effectiveness of different modes of fluoride delivery in reducing the incidence of DWLs, as well as the size of lesions. Participant-assessed outcomes, such as perception of DWLs, and oral health–related quality of life data were to be included, as would reports of adverse effects.
Summary of main results
Moderate-quality evidence from one trial at low risk of bias indicates that fluoride varnish applied every six weeks is associated with a reduction in new demineralised white lesions (DWLs) (Summary of findings for the main comparison).
Evidence is insufficient to show whether amine fluoride and stannous fluoride toothpaste/mouthrinse combination is more or less effective than sodium fluoride toothpaste/mouthrinse combination in preventing DWLs, visible plaque or gingivitis.
Evidence is also insufficient to show whether a reduction in the development of DWLs occurs with the use of an intraoral fluoride-releasing glass bead device.
Overall completeness and applicability of evidence
The latest update of the review has included only parallel-group trials, in which the individual participant is the unit of randomisation. This was decided upon because of the possibility of cross-contamination between experimental and control teeth in the same mouth, either between upper and lower arches or between sides of the mouth, which might lead to under-estimation of the effectiveness of any fluoride products.
Interventions that rely on the patient for delivery, including fluoride mouthrinse and toothpaste, will work only if they are used regularly. They rely greatly on patient compliance to succeed; however, evidence suggests that compliance with mouthrinsing is poor among orthodontic patients. One study (Geiger 1992) found that only 42% of participants rinsed with a sodium fluoride mouthrinse at least every other day. Results also showed that those who complied least with fluoride rinsing regimens tended to have more DWLs. It is important to consider the acceptability of interventions to both adolescents and adults with a view toward increasing compliance with recommended dental hygiene practices.
Interventions that are professionally applied and deliver fluoride 'passively', such as fluoride varnish, fluoride-releasing bracket cements and fluoride-releasing elastics, avoid the need for patient compliance. In addition, these materials deliver fluoride close to the bracket, where it is most needed; however, many fluoridated materials release large amounts of fluoride initially, but the level drops rapidly and might not be sufficient to prevent decay over the whole course of orthodontic treatment. Reapplication of fluoride varnish and frequent replacement of fluoride-releasing elastics are likely to be required. In the parallel-group trial of a fluoride varnish intervention included in this review, varnish was reapplied every six weeks at each orthodontic check-up appointment. We found no parallel-group trials of fluoride-releasing cements or elastics that met the inclusion criteria for this review.
An interesting addition, since the initial review was carried out, is the further development of materials that produce a slow and sustained release of fluoride (Luther 2005). This trial was small and at high risk of bias, and evidence was insufficient to reveal whether these devices are more or less effective than a mouthrinse in reducing the development of DWLs. It is possible, that with further refinement, this technique could potentially be effective. Intraoral fluoride-releasing devices should be evaluated by double-blind parallel-group randomised controlled trials.
When examining the effectiveness of a fluoride product in preventing dental decay, one should consider two aspects: first, whether the fluoride product reduces the number of DWLs appearing during treatment, and second, whether it reduces the severity of DWLs in terms of the size or area of the tooth surface affected, the amount of mineral lost or the depth of decay. Banks et al (Banks 2000) developed the Enamel Decalcification Index, which is an ordinal index that includes an assessment of the area covered. Assessment of the size of the lesion is a useful outcome measure, but none of the studies included in this review reported this outcome.
Ideally the appearance of the tooth should be recorded before and after orthodontic treatment, so that the change in appearance of the tooth is measured (incidence), not just its appearance at the end (prevalence). There are many different causes of white lesions on the teeth, many of which occur during the development of the teeth. It is important that these development lesions, as well as decay that has occurred before the brace is fitted, are excluded from the analysis, hence the need for the images (photographs or fluorescent) taken before treatment. Measurement of both incidence and severity will depend on the method used to record DWLs. Two main methods may be used: visual inspection and clinical images. Both methods are associated with problems. One problem with visual inspection is that the examiner or examiners will require calibration at the start and regular recalibration throughout the experimental period to ensure consistency of measurement. The duration of the experiment might be quite long because, as discussed later, the product should ideally be tested over the entire length of orthodontic treatment. This can take between 18 and 30 months - sometimes longer. Another problem with visual recording involves masking of the assessor to the allocated intervention. To reduce bias, the examiner should not know whether the participant has received a fluoride product and this will complicate the way the experiment is run.
Images have the advantage of providing a permanent record of the appearance of the tooth. Assessments can be carried out by several people independently or in groups, whereby a consensus is achieved. The images can be placed in a random order and the judges masked to group allocation. In addition, because the assessment can be performed over a short period of time the problem of examiner drift, whereby an assessor might subtly change his or her assessment over time, is reduced. The challenge of using clinical photographs consists of achieving consistency in lighting and reducing reflections that can mask or mimic DWLs; however, when a careful photographic technique is applied, the advantages of photographs outweigh their potential disadvantages. Several optical and fluorescent methods are available for measuring lesions on the teeth (Angmar-Mansson 1996). These methods require specialised equipment, which would add considerably to the cost of a clinical study, but they provide an objective measurement of the amount of decay in terms of mineral loss or lesion depth or both.
Quality of the evidence
It is important to note that only one study included in this review was judged to be at low risk of bias, and this assessment was made only after contact with the author resulted in clarification of two issues. Both the design and the reporting of trials of fluorides for preventing DWLs were generally poor, even in the most recent trials published in journals for which the use of CONSORT guidelines has been adopted. In particular, the methods of random allocation, sequence generation and concealment were rarely explained. Few studies provided a flow diagram to show withdrawals and drop-outs.
Potential biases in the review process
We undertook a sensitive search of several electronic sources, supplemented by searches of references lists. We placed no restriction on language or publication status. The review authors have tried, as far as possible, to identify all possible studies that might meet the inclusion criteria for this review. Study authors have been contacted, and many have replied; however, some were not able to supply the requested information, as their records have been destroyed or lost.
When a product, such as a bonding material, can be applied to single teeth, it is tempting to use an experimental design whereby the material being tested is used in two quadrants of the mouth and the control material is used in the other two quadrants. This is called a split-mouth design. The main advantage of the split-mouth design over a conventional parallel-group study design, in which the two materials are tested in two separate groups of individuals, is that the experimental material is tested in the same mouth, under the same conditions as the control material. In theory, any differences in outcome between the two materials are due only to their properties - not to other factors, such as differences in oral hygiene and diet between participants (with a parallel design) or even differences in oral hygiene and diet over time within the same participants (with a cross-over design).
Unfortunately, when one is examining the ability of fluoride products to reduce decay, it is highly unlikely that the fluoride released will be confined to only the quadrants/teeth in which the experimental material has been placed, and some contamination of the 'untreated' teeth is inevitable. This contamination will reduce the difference in outcomes between treated and untreated teeth. The previous version of this review included split-mouth studies, which failed to show any difference between treated and untreated teeth; this may be due to cross-over contamination between control and experimental sides and may reflect our contention of contamination. For this reason, we have decided to exclude split-mouth studies from this update of our review, and we recognise that changes to the protocol introduce a risk of bias to the review process.
Agreements and disagreements with other studies or reviews
Three other systematic reviews gathering evidence for the most effective means of preventing caries/demineralisation during fixed orthodontic appliance treatment have been reported in the literature. Derks et al (Derks 2004) examined all preventive measures for preventing demineralisation - not just fluoride products. These review authors had to exclude many published studies as well because of inappropriate research design or poor reporting and were unable to provide firm, evidence-based recommendations as to the prevention of DWLs during fixed orthodontic treatment.
A second systematic review (Chadwick 2005) investigated the effectiveness of topical fluorides used alone in preventing demineralisation during orthodontic treatment. These review authors included seven studies in their review; however, these studies were excluded from our review because the outcomes were not appropriate (DMFT/DMFS), or the participants were not examined immediately after removal of the fixed appliance(s). Although they suggest that according to their outcome measure (preventive fraction), some evidence shows that the addition of a topical fluoride preparation helps in the prevention of demineralisation during fixed orthodontic treatment, this conclusion must be viewed with caution, because these review authors were not able to calculate confidence intervals. We support their request that researchers design and report their studies using standard outcomes, so that in the future, data may be pooled and overall recommendations on preventive measures may be provided.
Rogers et al (Rogers 2010) included 10 studies in their systematic review investigating the effectiveness of fluoride-containing bonding adhesives used in orthodontics to prevent demineralisation. Five of these studies were excluded from our review because they were not randomised, and a further three studies were excluded because data in the report were insufficient, and the study authors, when contacted, were unable to provide requested data. Rogers' conclusions are consistent with ours with regard to the design of trials and the quality of reporting and statistical analyses.
Thanks are due to Helen Worthington (Cochrane Oral Health Group) for invaluable help with the statistics and to Sylvia Bickley and Anne Littlewood, Trials Search Co-ordinators for the Cochrane Oral Health Group, for carrying out the searches for the review.
Our thanks to Helen Worthington for her assistance with the 2013 update of this review.
For help with the translations of foreign papers, our thanks go to Regina Mitezki (German), Luisa Fernandez Mauleffinch (Spanish) and Dr Mikako Hayashi (Japanese).
We would also like to thank the following investigators who replied to our requests for additional information about their trials: PA Banks (Fairfield General Hospital, Burnley), AJ Borislow (Albert Einstein Medical Center), JP Fricker (Westmead Centre Dental Clinical School), G Pauw (University of Ghent), JDB Featherstone (University of California at San Fransisco), CR Mattick (University of Newcastle upon Tyne), L Mitchell (St Luke's Hospital, Bradford), B Øgaard (University of Oslo), RC Pascotto (State University of Maringa), M Persson (Umeå University), AL Sonis (Harvard School of Dental Medicine), C Stecksen-Blicks, PJ Turner (University of Birmingham) and S Twetman (Umeå University).
We acknowledge the contribution of Suzy Vine, who assessed the eligibility of trials, extracted data and assessed the quality of the trials in the original version of this review.
For their help as referees of the original review, we express our thanks to Jayne Harrison, Sylvia Bickley, Helen Worthington, Anne-Marie Glenny, Lee Hooper, Richard Ellwood, Sue Higham and Aubrey Sheiham. Our thanks to the referees for the 2013 update: Scott Deacon, Ruth Floate, Anne Littlewood, Phil Riley and Helen Worthington.
Appendix 1. Cochrane Oral Health Group's Trials Register search strategy
(orthodontic* AND (cariostatic* OR fluoride* OR naf OR "glass ionomer*" OR "cermet cement*" OR compomer* OR "composite resin*") AND ("dental enamel solubility" OR caries OR "dental fissures" OR demineriali* OR reminerali* OR decalcifi* OR "white spot*" or lesion*))
Appendix 2. Cochrane Central Register of Controlled Trials (CENTRAL) search strategy
#1 MeSH descriptor Orthodontics explode all trees
#3 (#1 OR #2)
#4 MeSH descriptor Sodium Fluoride explode all trees
#5 MeSH descriptor Fluorides, Topical explode all trees
#7 topical next fluoride*
#9 MeSH descriptor Glass Ionomer Cements, this term only
#10 glass next ionomer*
#11 (#4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10)
#12 MeSH descriptor Dental Enamel Solubility explode all trees
#13 MeSH descriptor Tooth Demineralization explode all trees
#14 reminerali* or deminerali* or decalcif*
#15 white next spot*
#16 (#12 OR #13 OR #14 OR #15)
#17 (#3 AND #11 AND #16)
Appendix 3. MEDLINE (OVID) search strategy
exp SODIUM FLUORIDE/
exp FLUORIDES TOPICAL/
Glass Ionomer Cements/
(glass adj ionomer$).mp.
exp DENTAL ENAMEL SOLUBILITY/
(reminerali$ or deminerali$ or decalcif$).mp.
((white adj spot$) or lesion$).mp.
11 or 12 or 13 or 14
3 and 10 and 15
The above subject search was linked to the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomised trials in MEDLINE: sensitivity maximising version (2008 revision), as referenced in Chapter 188.8.131.52 and detailed in Box 6.4.c of theCochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 [updated March 2011].
1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
5. drug therapy.fs.
10. exp animals/ not humans.sh.
11. 9 not 10
Appendix 4. EMBASE (OVID) search strategy
1 or 2
exp SODIUM FLUORIDE/
exp FLUORIDES TOPICAL/
Glass Ionomer Cements/
(glass adj ionomer$).mp.
exp DENTAL ENAMEL SOLUBILITY/
(reminerali$ or deminerali$ or decalcif$).mp.
((white adj spot$) or lesion$).mp.
3 and 10 and 15
The above subject search was linked to the Cochrane Oral Health Group filter for identifying RCTs in EMBASE via OVID.
3. (crossover$ or cross over$ or cross-over$).ti,ab.
5. (doubl$ adj blind$).ti,ab.
6. (singl$ adj blind$).ti,ab.
10. CROSSOVER PROCEDURE.sh.
11. DOUBLE-BLIND PROCEDURE.sh.
12. RANDOMIZED CONTROLLED TRIAL.sh.
13. SINGLE BLIND PROCEDURE.sh.
15. ANIMAL/ or NONHUMAN/ or ANIMAL EXPERIMENT/
17. 16 and 15
18. 15 not 17
19. 14 not 18
Appendix 5. US National Institutes of Health Trials Register search strategy
We used the search terms "orthodontic* and fluoride" to search this database on 25 June 2013 (http://clinicaltrials.gov).
Contributions of authors
Philip Benson wrote the protocol and co-ordinated the review. Philip Benson, Fiona Dyer, Peter Germain, Declan Millett and Nicola Parkin independently and in duplicate assessed the eligibility of trials, extracted data and assessed the quality of the trials. Philip Benson contacted authors, entered the data, carried out the statistical analysis (with help from Helen Worthington) and wrote the review. Declan Millett proofread the review.
For the 2013 update of this review, Philip Benson and Susan Furness contacted authors, assessed risk of bias, extracted and entered data, carried out the statistical analysis (with help from Helen Worthington) and wrote the text of the review.
Differences between protocol and review
In the 2013 update of this review, controlled clinical trials (quasi-randomised) were excluded.
A point of clarification was added to the inclusion criteria for this review. For a randomised controlled trial to be included, demineralised white lesions (DWLs) must be assessed on teeth remaining in the mouth. Studies that evaluated demineralisation of extracted teeth were excluded from the 2013 update of this review because they measured the effects of short-term exposure to fluoride (four to six weeks between application and extraction of the teeth). Furthermore, it was decided that evaluation of demineralisation must take place at the end of treatment with fixed orthodontic appliances (debonding).
As stated in the Discussion of the previous version of this review, the use of a split-mouth study design to evaluate these interventions is potentially inappropriate. It is unlikely that the fluoride released will be confined to only the quadrants or the specific teeth in which the experimental material has been placed, and some 'contamination' of teeth in the control quadrants is inevitable. This will reduce the difference in outcome between experimental and control teeth and will reduce the power of the trial to find a difference. Indeed split-mouth studies included in the previous version of this review found no difference between teeth with fluoridated bracket adhesives and those without, supporting the view that this design is inappropriate for evaluating topical fluorides. Split-mouth studies were excluded from the 2013 update of this review, and the Methods sections of this review was amended to remove methods that were used to deal with split-mouth studies.