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Fluorides for the prevention of early tooth decay (demineralised white lesions) during fixed brace treatment

  1. Philip E Benson1,*,
  2. Nicola Parkin1,
  3. Fiona Dyer1,
  4. Declan T Millett2,
  5. Susan Furness3,
  6. Peter Germain4

Editorial Group: Cochrane Oral Health Group

Published Online: 12 DEC 2013

Assessed as up-to-date: 31 JAN 2013

DOI: 10.1002/14651858.CD003809.pub3


How to Cite

Benson PE, Parkin N, Dyer F, Millett DT, Furness S, Germain P. Fluorides for the prevention of early tooth decay (demineralised white lesions) during fixed brace treatment. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD003809. DOI: 10.1002/14651858.CD003809.pub3.

Author Information

  1. 1

    School of Clinical Dentistry, University of Sheffield, Academic Unit of Oral Health and Development, Sheffield, UK

  2. 2

    Cork University Dental School and Hospital, Oral Health and Development, Cork, Ireland

  3. 3

    School of Dentistry, The University of Manchester, Cochrane Oral Health Group, Manchester, UK

  4. 4

    Newcastle Dental Hospital, Department of Orthodontics, Newcastle upon Tyne, Tyne and Wear, UK

*Philip E Benson, Academic Unit of Oral Health and Development, School of Clinical Dentistry, University of Sheffield, Claremont Crescent, Sheffield, S10 2TA, UK. p.benson@sheffield.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 12 DEC 2013

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Characteristics of included studies [ordered by study ID]
Luther 2005

MethodsTrial design: 2-arm parallel-group RCT

Unit of randomisation: Participants

Location: Leeds, UK

Number of centres: 1

Recruitment period: December 1998 to December 1999

Funding source: BDA Research Foundation Shirley Glasstone Hughes Memorial Prize Fund and the Listerine Preventive Care Award


ParticipantsInclusion criteria: Participants with upper incisors and canines developing and at least 3 upper permanent incisors and 1 upper permanent canine erupted, prior to commencement of orthodontic treatment with fixed upper appliances

40 F/28 M (sic)

Exclusion criteria: Participants with grossly damaged, restored or defective upper permanent canines or incisors, participants living in areas with fluoridated water supply, physically or mentally handicapped individuals, those with comorbidities or requiring antibiotic cover and pregnant or nursing females

Mean age at baseline, years: 15.7 (range 11 to 45)

Number randomised: 70 (34 F-releasing glass bead and 36 F rinse)

Number evaluated: 37 (18 F-releasing glass bead and 19 F rinse)


InterventionsComparison: Fluoride-releasing glass beads versus fluoride rinse

Group A (n = 18): Fluoride-releasing glass bead (containing 13.3% F) attached to appliance 

Group B (n = 19):  Fluoride rinse (Endekay 0.05% NaF). Participants instructed to use 5 drops in 10 ml of water and to rinse once daily

Duration of treatment: Approximately 19 months (recruitment ended December 1999; final data collection September 2002)


OutcomesBefore and after cross-polarised images of 6 upper anterior teeth, assessed by a masked individual using image analysis, salivary fluoride levels


NotesBackground exposure to fluoride not reported: Unclear whether participants used fluoride toothpaste

Power calculation reported that 28 participants/group would be needed to show the expected 75% difference; it was planned to recruit 35 per group to allow for drop-outs

Large numbers of participants both withdrawing or dropping out (total 14: 6 control, 8 experimental), as well as insufficient data for analysis (total 19: 11 control, 8 experimental). Null findings should be interpreted with caution, as investigators lost so many in their sample, which means that it is likely that this study lacks statistical power


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "A random number table was generated on an Excel spreadsheet by the trial’s statistical advisor"

Allocation concealment (selection bias)Low riskQuote: "Each time a patient agreed to take part in the study, a dental nurse who was not involved in the running of the study accessed the concealed table and crossed off the next number, informing the operator of the treatment to be used i.e. whether the patient had been allocated to the fluoride rinse or FGB group"

Blinding - Patients & OperatorsHigh riskNot possible to blind participants or operators to allocated intervention

Blinding - Outcome assessorsLow riskQuote: "Analysis was undertaken blind by one operator, who was unaware of which group the teeth being analysed came from"

Incomplete outcome data addressedHigh risk14 participants (8 F-releasing glass bead and 6 rinse) dropped out - reasons not given. Further 19 (8 F-releasing glass bead and 11 rinse) excluded from analysis because of insufficient data, and reasons not explained. 47% of randomised participants not included in the analysis. High rate of breakage of F-releasing glass beads. Substantial risk of bias due to attrition

Free of selective reportingUnclear riskNumbers of participants and teeth with DWLs reported at the beginning and at the end of the trial, but denominators were unclear. No indication of mean size of lesions in each group. Salivary fluoride levels not reported

Free of other biasUnclear riskNumber of breakages of F-releasing glass beads reported, but no indication of level of compliance in fluoride rinse group. No information on duration of trial and therefore duration of exposure to fluoride in each group

Stecksén-Blicks 2007

MethodsTrial design: Parallel RCT

Unit of randomisation: Individuals

Location: Skelleftea & Lycksele, Sweden

Number of centres: 2

Recruitment period: Not stated

Funding source: Grants from the County Council of Vasterbotten & Swedish Dental Society, with varnishes supplied by Ivoclar Vivadent and brackets by 3M Unitek


ParticipantsInclusion criteria: Children 12 to 15 years of age scheduled for maxillary treatment with fixed orthodontic appliances for an expected duration of at least 6 months

Exclusion criteria: None stated

Mean age at baseline, years: 14.3 ± 1.6

Number randomised: 273 (137 and 136)

Number evaluated: 257 (132 and 125)


InterventionsComparison: Fluoride varnish (Fluor Protector) versus placebo

Group A (n = 137): Fluor Protector (0.1% F difluorosilane in polyurethane base) varnish applied after bonding and at each checkup (approximately every 6 weeks) until debonding

Group B (n = 136):  Placebo varnish, identical in appearance to active, applied after bonding and at the end of each check-up (every 6 weeks) until debonding

In both groups, after removal of visible plaque with an explorer, 0.2 to 0.3 ml varnish was applied around the bracket bases in a thin layer with a minibrush and was allowed to dry for 2 minutes. Participants were instructed to avoid all eating and drinking for 2 hours and to not brush teeth until the following day

Duration of treatment: Not given, but mean number of applications of varnish was 10, and assuming they were seen every 6 weeks, the mean duration was 60 weeks or just over 1 year (which is quite short)

All children strongly advised to brush teeth with 1000 to 1500 ppm fluoride toothpaste at least twice daily

Fluoride in piped drinking water in these communities was < 0.2 ppm


OutcomesBefore and after clinical photographs assessed for presence and severity of DWLs by 2 experienced and calibrated judges


NotesSample size calculation reported. Estimated requirement for 132 participants per group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote (author): "The patients were assigned to one of the two groups on the basis of odd and even numbers from a dice"

Comment: The corresponding author was asked how investigators obtained equal numbers in all groups but does not seem to have answered this

Allocation concealment (selection bias)Low riskQuote (author): "The study was coordinated from the Department of Paediatric Dentistry and the randomization was performed there by an independent technician not involved in the clinical work and collection of data"

Blinding - Patients & OperatorsLow riskQuote (author): "The placebo varnish applied had an identical composition but without fluoride. Both varnishes were uncoloured and obtained from the producer in identical bottles coded by colour. Neither clinicians nor patients knew whether they were treated with fluoride or placebo varnish"

Comment: The study was double-blind

Blinding - Outcome assessorsLow riskQuote: The two "experienced and calibrated" judges who scored the photographs for presence/absence and severity of DWLs "were not involved in the treatment of the patients and blinded for group assignment"

Incomplete outcome data addressedLow riskComment: Flow diagram provided and withdrawals and drop-outs reported (5/137 or 4% experimental; 11/136 or 8% controls). Reasons given and similar in each group. Unlikely to have introduced a bias

Free of selective reportingLow riskPlanned outcome was white spot lesions at debonding in each group. Reported as % prevalence with P value for difference between groups. No apparent evidence of selective reporting

Free of other biasLow riskNo other sources of bias identified

Øgaard 2006

MethodsTrial design: 2-arm double-blind parallel-group RCT

Unit of randomisation: Individual

Location: Sweden

Number of centres: 2

Recruitment period: Starting orthodontic treatment in1999

Funding source: The study was supported by GABA International, Basel, Switzerland


ParticipantsInclusion criteria: Participants were those starting orthodontic treatment in 1999 with fixed appliances in both arches

Exclusion criteria: None stated

Age at baseline: Not stated

Number randomised: 115

Number evaluated: 97


InterventionsComparison: 2 different fluoride toothpastes and mouthrinses

Group A (n = 50): Participants were instructed to brush twice daily with toothpaste containing amine fluoride and stannous fluoride combination (AmF/SnF2 140 ppm, pH 4.5) and to rinse every evening after toothbrushing with a solution containing amine fluoride and stannous fluoride

Group B (n = 47): Participants were instructed to brush twice daily with toothpaste containing neutral sodium fluoride (NaF 1400 ppm, pH 6.7) and to rinse every evening after toothbrushing with a solution containing NaF (250 ppm, pH 6.3)

Duration of treatment: Fluoride treatments were continued for the whole duration of orthodontic treatment with fixed appliances


OutcomesWhite spot lesion index, visible plaque index, gingival bleeding index, measured at baseline and at debonding


NotesBackground exposure to fluoride: Not reported

Power calculation: Not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "allocated to two groups at bonding according to a randomized table"

Comment: Assumed this refers to random number table

Allocation concealment (selection bias)Unclear riskNot described

Comment: Assumed not done

Blinding - Patients & OperatorsLow riskDouble-blind. Quote: "Neither the subjects nor the research team were informed about which group each participant belonged to"

Blinding - Outcome assessorsLow riskDouble-blind. Quote: "Neither the subjects nor the research team were informed about which group each participant belonged to"

Incomplete outcome data addressedLow risk18 of the patients invited to participate were not included in the evaluation. Not stated which groups they were from, but it seems likely that number was similar in each group. Reason given was moving house

Free of selective reportingLow riskPlanned outcomes reported in full

Free of other biasLow riskNo other sources of bias identified

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Alexander 2000Clinical assessment carried out 1 month after debonding not immediately after

Alwi 1994Abstract only. Insufficient information to include in review. Contacted author. Unable to provide sufficient data for analysis. No subsequent publication identified

Banks 1997Split-mouth study

Banks 2000CCT with alternate allocation to fluoride or non-fluoride elastomeric ligatures

Blanco 1988"Patients chosen at random" and divided into 2 groups. Report is unclear about the details of allocation to each group, groups are unequal in size, no baseline characteristics, and no outcome data presented per participant. Unable to contact authors and unable to include this study based on available information

Boyd 1992Demineralisation assessed 3 months after debonding rather than immediately

Boyd 1993Demineralisation assessed 3 months after debonding rather than immediately

Boyles 2007Not RCT

Buyukyilmaz 1994Split-mouth study

Chung 1998Split-mouth study

Czochrowska 1998Split-mouth study

D'Agostino 1988Outcomes were DMFT and DMFS not demineralised white lesions

Demito 2011Split-mouth study

Dyer 1982Not RCT

Dénes 1988Assessed DMFS not white spot lesions

Dénes 1989Assessed DMFS not white spot lesions

Dénes 1991Assessed DMFS not white spot lesions

Farhadian 2008Not RCT

Fricker 1985Not RCT

Fricker 1987Not RCT

Gaworski 1999Not RCT

Geiger 1988Not RCT

Geiger 1992Not RCT

Gillgrass 2001Split-mouth study

Gorton 2003Ex vivo study - outcomes measured on extracted teeth

Hirschfield 1978Not RCT

Leizer 2010Appears to be allocation based on study number (odd or even) and teeth allocated alternately. CCT. No reply to emails sent to contact author

Maijer 1988Not RCT

Marcusson 1997Split-mouth study

Marini 1999Duration of intervention 12 months but outcomes assessed at end of treatment period not at the end of treatment with fixed orthodontic appliances

Mattick 2001Split-mouth RCT

Millett 1999Split-mouth study, allocation of each side to treatment by alternation. Not RCT

Millett 2000Split-mouth study, allocation of each side to treatment by alternation.Not RCT

Mitchell 1992Split-mouth study, no random allocation. Author contacted

Neumann 1976Abstract only. Insufficient data, no subsequent publication identified

O'Reilly 1987Ex vivo study - outcomes measured on extracted teeth

Pascotto 2004Ex vivo study - outcomes measured on extracted teeth

Robertson 2011Duration of intervention 12 months but outcomes assessed at end of treatment period not at the end of treatment with fixed orthodontic appliances

Salzmann 1976Abstract only. No subsequent publication identified

Shan 2008Split-mouth study

Shannon 1978Allocation method not stated. Unable to contact the authors

Shannon 1979Allocation method not stated. Unable to contact the authors

Sköld-Larsson 2013Intervention period was short (12 weeks) and assessments were not undertaken at the start and end of orthodontic treatment

Sonis 1989Not RCT

Trimpeneers 1996Split-mouth study. All participants had the same product used in the same quadrants. Not RCT.Contacted author (LR Dermaut). Unable to provide further data for statistical analysis

Turner 1993Split-mouth study

Twetman 1997Split-mouth study

Ullsfoss 1994Both groups had fluoride mouthrinse. The experimental group had in addition an antimicrobial mouthrinse, therefore the study looks at the efficacy of the antimicrobial mouthrinse rather than the fluoride mouthrinse

Underwood 1989Random allocation not mentioned. Brackets on alternate teeth bonded with each adhesive. Not RCT

van der Linden 1998Split-mouth study

Vivaldi-Rodrigues 2006Split-mouth study

Wenderoth 1999 Not RCT

Øgaard 1986Ex vivo study - outcomes measured on extracted teeth

Øgaard 1992Random allocation to treatment not mentioned. Author contacted

Øgaard 1996Not RCT. Author contacted

Øgaard 1997Effect of fluoride confounded by co-intervention. Both groups had fluoride varnish. The experimental group had in addition an antimicrobial varnish therefore the study looks at the efficacy of the antimicrobial varnish rather than the fluoride varnish

Øgaard 2001Effect of fluoride confounded by co-intervention. 2 randomised groups and 1 non-randomised control group. Both randomised groups received fluoride varnish every 12 weeks, fluoride exposure was not different between the 2 randomised groups

 
Characteristics of ongoing studies [ordered by study ID]
NCT00268138

Trial name or titlePhase 4 study on prevention of incipient carious lesions (white spot lesions) in patients with fixed orthodontic appliances following the application of Elmex gel

MethodsParallel-group, double-blind RCT

Participants314 healthy participants between 10 and 60 years of age, undergoing orthodontic treatment

InterventionsToothbrushing with Elmex gel or placebo product once weekly during the entire study (12 to 30 months) plus tray application of test or control product 4 times per year

OutcomesVisually detected white spot lesions

Starting dateApril 2006

Contact informationPrincipal Investigators Dr Meir Radlich (mredlich@zahav.net.il) and Prof Paul George Jost-Brinkman (paul-g.jost-brinkmann@charite.de)

NotesEmail sent to Jost-Brinkmann to request results 19/7/2012. Email reply 19/7/2012 stating that last participant now finished and data analysis about to start

NCT01768390

Trial name or titleCaries-preventive effectiveness of a dentifrice containing 5000 ppm fluoride - a randomised controlled trial in adolescents with fixed orthodontic appliances

MethodsParallel-group single-blind RCT

Participants420 healthy participants 11 to 16 years old, undergoing orthodontic treatment

InterventionsHigh-dose (5000 ppm) fluoride toothpaste versus usual-dose (1450 ppm) fluoride toothpaste

OutcomesIncidence and severity of white spot lesions over the duration of orthodontic treatment (18 to 24 months)

Starting dateJanuary 2008. Data collection expected to be complete July 2012

Contact informationProfessor SHA Twetman, University of Copenhagen (stw@odont.ku.dk )

NotesEmail sent to Prof Twetman 24 June 2013. Reply 25 June 2013: "The study is completed and the manuscript was submitted for publication about one month ago. We have not yet received any response from the journal but if we are lucky, it will appear "on line" later this year." Abstract presented at European Orthodontic Society meeting, Reykjvik, Iceland, June 2013

NCT01925924

Trial name or titleResin-modified glass ionomer or composite for orthodontic bonding? A multicentre, randomised, single-blinded clinical trial

MethodsA multicentre randomised single-blinded controlled clinical trial with 2 parallel groups

Participants206 orthodontic patients requiring upper and/or lower preadjusted edgewise fixed appliance therapy, 11 years of age or older

InterventionsBrackets will be bonded to all teeth in front of the first permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a light cured composite control (Transbond)

OutcomesPrimary: Incidence and severity of demineralisation at the end of treatment. Secondary: Incidence of first time bond failures

Starting dateFebruary 2009

Contact informationDr Philip Benson, University of Sheffield (p.benson@sheffield.ac.uk)

Notes

 
Comparison 1. Fluoride varnish versus placebo varnish

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of participants with new DWLs1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

 
Comparison 2. Amine fluoride/stannous fluoride toothpaste/mouthrinse combination versus sodium fluoride toothpaste/mouthrinse combination

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 White spot index1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Visible plaque index1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 3 Gingival bleeding index1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 3. Intraoral fluoride-releasing glass bead device versus mouthrinse-only control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of participants with new DWLs1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Fluoride-releasing intraoral device versus fluoride mouthrinse
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Summary of findings for the main comparison. Fluoride varnish versus placebo varnish

Fluoride varnish versus placebo varnish for the prevention of demineralised white lesions on teeth during fixed brace treatment

Patient or population: Participants undergoing orthodontic treatment with fixed appliances
Settings: Orthodontic practice
Intervention: Fluoride varnish

Comparison: Placebo varnish

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Placebo varnishFluoride varnish

Number of patients with new demineralised white lesionsStudy populationRR 0.31
(0.21 to 0.44)
253
(1 study)
⊕⊕⊕⊝
moderate1

640 per 1000198 per 1000
(134 to 282)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 A single study with 253 participants evaluated this outcome. Risk of bias was assessed as low. However, this finding should be interpreted with caution until the study has been replicated.