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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 1

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Study flow diagram.
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Figure 2

Study flow diagram.

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Comparison 1 Professionally‐applied F varnish versus non‐F (placebo) varnish, Outcome 1 Number of participants with new DLs.
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Analysis 1.1

Comparison 1 Professionally‐applied F varnish versus non‐F (placebo) varnish, Outcome 1 Number of participants with new DLs.

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Comparison 1 Professionally‐applied F varnish versus non‐F (placebo) varnish, Outcome 2 Number of participants with more severe DLs (scores 3 or 4 versus scores 1 or 2).
Figuras y tablas -
Analysis 1.2

Comparison 1 Professionally‐applied F varnish versus non‐F (placebo) varnish, Outcome 2 Number of participants with more severe DLs (scores 3 or 4 versus scores 1 or 2).

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Comparison 2 12,500 ppm F (NaF/olaflur/dectaflur) gel versus 0 ppm F placebo gel, Outcome 1 Number of participants with new DLs.
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Analysis 2.1

Comparison 2 12,500 ppm F (NaF/olaflur/dectaflur) gel versus 0 ppm F placebo gel, Outcome 1 Number of participants with new DLs.

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Comparison 3 12,300 ppm F APF foam versus 0 ppm F placebo foam, Outcome 1 Number of participants with new DLs.
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Analysis 3.1

Comparison 3 12,300 ppm F APF foam versus 0 ppm F placebo foam, Outcome 1 Number of participants with new DLs.

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Comparison 4 5000 ppm F toothpaste versus 1450 ppm F toothpaste, Outcome 1 Number of participants with new DLs.
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Analysis 4.1

Comparison 4 5000 ppm F toothpaste versus 1450 ppm F toothpaste, Outcome 1 Number of participants with new DLs.

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Comparison 5 250 ppm F mouthrinse (100 ppm AmF/150 ppm NaF) versus 0 ppm F placebo mouthrinse, Outcome 1 Number of participants with new DLs.
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Analysis 5.1

Comparison 5 250 ppm F mouthrinse (100 ppm AmF/150 ppm NaF) versus 0 ppm F placebo mouthrinse, Outcome 1 Number of participants with new DLs.

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Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 1 White spot index.
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Analysis 6.1

Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 1 White spot index.

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Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 2 Visible plaque index.
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Analysis 6.2

Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 2 Visible plaque index.

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Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 3 Gingival bleeding index.
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Analysis 6.3

Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 3 Gingival bleeding index.

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Comparison 7 Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC), Outcome 1 Number of participants with new DLs.
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Analysis 7.1

Comparison 7 Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC), Outcome 1 Number of participants with new DLs.

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Comparison 7 Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC), Outcome 2 Number of participants with more severe DLs of aesthetic concern.
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Analysis 7.2

Comparison 7 Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC), Outcome 2 Number of participants with more severe DLs of aesthetic concern.

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Comparison 8 Intraoral F‐releasing glass bead device versus F mouthrinse only, Outcome 1 Number of participants with new DLs.
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Analysis 8.1

Comparison 8 Intraoral F‐releasing glass bead device versus F mouthrinse only, Outcome 1 Number of participants with new DLs.

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Summary of findings for the main comparison. Dentist/nurse‐applied fluoride: fluoride varnish compared to non‐fluoride (placebo) varnish for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Fluoride varnish compared to non‐fluoride (placebo) varnish for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: orthodontic clinics in Sweden
Intervention: fluoride varnish
Comparison: non‐fluoride (placebo) varnish

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

With non‐fluoride (placebo) varnish

With fluoride varnish

Difference

Number of participants with new DLs (new DLs)

Assessed with: pre‐treatment and day of debond clinical intraoral photographs

Follow‐up: 1.7 years

28.80%

15%
(4 to 55.60)

13.80% fewer
(24.80 fewer to 26.80 more)

RR 0.52
(0.14 to 1.93)

405
(2 RCTs)

⊕⊕⊝⊝
LOWa,b

The evidence that professional application of fluoride varnish (7700 or 10,000 ppm F) every 6 weeks to the teeth of patients wearing fixed orthodontic braces reduces the number of new DLs is equivocal

Number of participants with more severe DLs (severity of DLs) (score 3 or 4 versus score 1 or 2)

Follow‐up: 1.7 years

26%

12%
(5.70 to 24.70)

14.10% fewer
(20.30 fewer to 1.30 fewer)

RR 0.46
(0.22 to 0.95)

148
(1 RCT)

⊕⊕⊝⊝
LOWc,d

The evidence suggests that when a dentist or nurse applies 7700 ppm F (ammonium fluoride) varnish every 6 weeks to a patient wearing a fixed orthodontic brace there may a reduction in the number of orthodontic patients with more severe DLs (score 3 or 4 versus score 1 or 2)

Number of participants with adverse effects (adverse effects)

Follow‐up: 1.7 years

No evidence that the intervention had adverse effects

148
(1 RCT)

⊕⊕⊝⊝
LOWd,e

Only 1 participant with an adverse event and not clear if this was directly related to the intervention

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; DLs: demineralised lesions; F: fluoride; ppm: parts per million; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded 1 level for indirectness (evidence from only 2 studies) (Stecksén‐Blicks 2007; Sonesson 2019).
bDowngraded 1 level for imprecision (insufficient number of participants with new DLs (guideline 300 to 400 events)).
cDowngraded 1 level for imprecision (insufficient number of participants with the more severe DLs (guideline 300 to 400 events)).
dDowngraded 1 level for indirectness (evidence from only 1 study) (Sonesson 2019).
eDowngraded 1 level for imprecision (insufficient number with adverse events and not clear if directly related to the intervention).

Figuras y tablas -
Summary of findings for the main comparison. Dentist/nurse‐applied fluoride: fluoride varnish compared to non‐fluoride (placebo) varnish for preventing early tooth decay (demineralised lesions) during fixed brace treatment
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Summary of findings 2. Dentist/nurse‐applied fluoride: 12,300 ppm F APF foam compared to 0 ppm F placebo foam for preventing early tooth decay (demineralised lesions) during fixed brace treatment

12,300 ppm F APF foam compared to 0 ppm F placebo foam for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: orthodontic department at dental hospital in China
Intervention: 12,300 ppm F APF foam
Comparison: 0 ppm F placebo foam

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Certainty of the evidence
(GRADE)

Number of participants (studies)

Comments

With 0 ppm F placebo foam

With 12,300 ppm F APF foam

Difference

Number of participants with new DLs (new DLs)

Assessed with: clinical assessment

Follow‐up: mean 18 months

48.90%

12.70%
(5.40 to 27.90)

36.20% fewer
(43.60 fewer to 21 fewer)

RR 0.26
(0.11 to 0.57)

⊕⊕⊝⊝
LOWa,b

95
(1 RCT)

The evidence suggests that when foam, containing 12,300 ppm F, is applied by a dentist or a nurse, every 2 months, to the teeth of patients wearing fixed orthodontic appliances there might be a reduction in the number of patients who have at least 1 new DL

Number of participants with more severe DLs (severity of DLs)

None of the trials reported this outcome

Number of participants with adverse effects (adverse effects)

None of the trials reported this outcome

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

APF: acidulated phosphate fluoride; CI: confidence interval; DLs: demineralised lesions; F: fluoride; ppm: parts per million; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aAlthough effect size is large this was only for 1 study at unclear risk of bias and therefore downgraded 1 level (Jiang 2013).
bDowngraded 1 level for imprecision (insufficient number of participants with new DLs (guideline 300 to 400 events)).

Figuras y tablas -
Summary of findings 2. Dentist/nurse‐applied fluoride: 12,300 ppm F APF foam compared to 0 ppm F placebo foam for preventing early tooth decay (demineralised lesions) during fixed brace treatment
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Summary of findings 3. Patient‐applied/used fluoride: 5000 ppm F toothpaste compared to 1450 ppm F toothpaste for preventing early tooth decay (demineralised lesions) during fixed brace treatment

5000 ppm F toothpaste compared to 1450 ppm F toothpaste for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: home use
Intervention: 5000 ppm F toothpaste
Comparison: 1450 ppm F toothpaste

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

With 1450 ppm F toothpaste

With 5000 ppm F toothpaste

Difference

Number of participants with new DLs (new DLs)

Assessed with: pre‐treatment and post‐treatment clinical intraoral photographs

Follow‐up: 1.8 years

26.60%

18.10%
(12.20 to 26.60)

8.50% fewer
(14.30 fewer to 0 fewer)

RR 0.68
(0.46 to 1.00)

380
(1 RCT)

⊕⊕⊝⊝
LOWa,b

The evidence suggests that in patients wearing an orthodontic fixed brace use of a daily 5000 ppm F toothpaste compared with a daily 1450 ppm F toothpaste throughout treatment may lead to a reduction in the number of orthodontic patients with new DLs

Number of participants with more severe DLs (severity of DLs)

None of the trials reported this outcome

Number of participants with adverse effects (adverse effects)

None of the trials reported this outcome

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; DLs: demineralised lesions; F: fluoride; ppm: parts per million; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded 1 level due to single study at unclear risk of bias (Sonesson 2014).
bDowngraded 1 level for imprecision (insufficient number of participants with new DLs (guideline 300 to 400 events)).

Figuras y tablas -
Summary of findings 3. Patient‐applied/used fluoride: 5000 ppm F toothpaste compared to 1450 ppm F toothpaste for preventing early tooth decay (demineralised lesions) during fixed brace treatment
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Summary of findings 4. Patient‐applied/used fluoride: 250 ppm F mouthrinse (100 ppm F amine F/150 ppm NaF) compared to 0 ppm F placebo mouthrinse for preventing early tooth decay (demineralised lesions) during fixed brace treatment

250 ppm F mouthrinse (100 ppm amine F/150 ppm NaF) compared to 0 ppm F placebo mouthrinse for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: home use
Intervention: 250 ppm F mouthrinse (100 ppm amine F/150 ppm NaF)
Comparison: 0 ppm F placebo mouthrinse

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

With 0 ppm F placebo mouthrinse

With 250 ppm F mouthrinse (100 ppm amine F/150 ppm NaF)

Difference

Number of participants with new DLs (new DLs)

Assessed with: QLF

Follow‐up: 24.5 months

46.70%

30.30%
(17.30 to 54.60)

16.30% fewer
(29.40 fewer to 7.90 more)

RR 0.65
(0.37 to 1.17)

81
(1 RCT)

⊕⊝⊝⊝
VERY LOWa,b

The evidence is very uncertain about the effect of a daily 250 ppm F mouthrinse (100 ppm amine F/150 ppm NaF) compared with a daily 0 ppm F placebo mouthrinse on the number of patients wearing a fixed orthodontic brace with new DLs

Number of participants with more severe DLs (severity of DLs)

None of the trials reported this outcome

Number of participants with adverse effects (adverse effects)

None of the trials reported this outcome

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; DLs: demineralised lesions; F: fluoride; NaF: sodium fluoride; ppm: parts per million; QLF: quantitative light‐induced fluorescence; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded 2 levels: single study with a relatively small number of participants (81), at high risk of bias due to high attrition (33%) (van der Kaaij 2015).
bDowngraded 1 level for imprecision (insufficient number of participants with new DLs (guidance 300 to 400 events)).

Figuras y tablas -
Summary of findings 4. Patient‐applied/used fluoride: 250 ppm F mouthrinse (100 ppm F amine F/150 ppm NaF) compared to 0 ppm F placebo mouthrinse for preventing early tooth decay (demineralised lesions) during fixed brace treatment
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Summary of findings 5. Fluoride‐releasing materials: resin‐modified glass ionomer cement compared to light‐cured composite resin for bonding orthodontic brackets for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Resin‐modified glass ionomer cement compared to light‐cured composite resin for bonding orthodontic brackets for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: 2 dental teaching hospitals and 4 specialist orthodontic practices in UK and Republic of Ireland
Intervention: resin‐modified glass ionomer cement
Comparison: light‐cured composite resin

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

With light‐cured composite resin

With resin‐modified glass ionomer cement

Difference

Number of participants with new DLs (new DLs)

Assessed with: before and day of debond clinical intraoral photographs

Follow‐up: 17.6 months

22.40%

26.20%
(15.40 to 44.50)

3.80% more
(6.90 fewer to 22.10 more)

RR 1.17
(0.69 to 1.99)

173
(1 RCT)

⊕⊕⊝⊝
LOWa,b

The evidence suggests that resin‐modified glass ionomer cement for bonding orthodontic brackets compared with light‐cured composite resin results in little to no difference in the number of orthodontic patients with new DLs

Number of participants with more severe DLs of aesthetic concern (severity of DLs)

Assessed with: pre‐treatment and day of debond clinical intraoral photographs

Follow‐up: 17.6 months

8.00%

9.40%
(3.60 to 24.80)

1.40% more
(4.40 fewer to 16.90 more)

RR 1.18
(0.45 to 3.12)

173
(1 RCT)

⊕⊕⊝⊝
LOWa,b

The evidence suggests that using resin‐modified glass ionomer cement for bonding orthodontic brackets compared with light‐cured composite resin results in little to no difference in the number of orthodontic patients with more severe DLs of aesthetic concern

Number of participants with adverse effects (adverse effects)

Follow‐up: 17.6 months

No evidence that either intervention had adverse effects

173
(1 RCT)

⊕⊕⊝⊝
LOWa,b

‐

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; DLs: demineralised lesions; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded 1 level: single study at unclear risk of bias (Benson 2019).
bDowngraded 1 level for imprecision (insufficient number of participants with new DLs or more severe DLs (guidance 300 to 400 events)).

Figuras y tablas -
Summary of findings 5. Fluoride‐releasing materials: resin‐modified glass ionomer cement compared to light‐cured composite resin for bonding orthodontic brackets for preventing early tooth decay (demineralised lesions) during fixed brace treatment
Ir a la tabla de la revisión
Table 1. Summary of findings for 12,500 ppm F (NaF/olaflur/dectaflur) fluoride gel compared to 0 ppm F placebo gel for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: dental clinics in Germany and Israel and home use
Intervention: 12,500 ppm F (NaF/olaflur/dectaflur) fluoride gel
Comparison: 0 ppm F placebo gel

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

With 0 ppm F placebo gel

With 12,500 ppm F (NaF/olaflur/dectaflur) fluoride gel

Difference

Number of participants with new DLs (new DLs)

Assessed with: clinical examination

Follow‐up: mean 16.6 months

42.90%

42.50%
(32.60 to 54.50)

0.40% fewer
(10.30 fewer to 11.60 more)

RR 0.99
(0.76 to 1.27)

312
(1 RCT)

⊕⊝⊝⊝
VERY LOWa,b,c

The evidence is very uncertain about the effect of an amine fluoride gel compared with a placebo gel on the number of patients wearing fixed orthodontic braces with new DLs

Number of participants with more severe DLs (severity of DLs)

None of the trials reported this outcome

Number of participants with adverse effects (adverse effects)

Follow‐up: mean 16.6 months

0.60%

0.00%
(0 to 0)

0.60% fewer
(0.60 fewer to 0.60 fewer)

Not estimable

312
(1 RCT)

⊕⊝⊝⊝
VERY LOWa,c,d

Authors write "Most AEs (96.4%) were unrelated to the study treatment. Only a single AE (hay fever) was considered related to the study treatment (placebo)." They go on to state "The use... for a maximum of 32.5 months was not associated with any unexpected ARs or AEs. Thus, there are no safety issues to be considered for long‐term use of elmex® gel"

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AE: adverse effects; CI: confidence interval; DLs: demineralised lesions; F: fluoride; NaF: sodium fluoride; ppm: parts per million; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded 1 level due to single study at unclear risk of bias (Jost‐Brinkman 2017).
bDowngraded 1 level for imprecision (insufficient number of participants with new DLs (guidance 300 to 400 events)).
cDowngraded 1 level for publication bias (data collection for the trial was completed in 2011. The results were obtained from the study report that was published in 2016, but not yet submitted to a peer‐reviewed journal).
dDowngraded 1 level for imprecision (insufficient number with adverse events).

Figuras y tablas -
Table 1. Summary of findings for 12,500 ppm F (NaF/olaflur/dectaflur) fluoride gel compared to 0 ppm F placebo gel for preventing early tooth decay (demineralised lesions) during fixed brace treatment
Ir a la tabla de la revisión
Table 2. Summary of findings for 1400 ppm/250 ppm F (amine F/SnF) toothpaste/mouthrinse compared to 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: home use
Intervention: 1400 ppm/250 ppm F (amineF/SnF) toothpaste/mouthrinse
Comparison: 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse

Risk with 1400 ppm/250 ppm F (amineF/SnF) toothpaste/mouthrinse

Number of participants with new DLs (new DLs)

Follow‐up: 1.5 years

Outcome not reported. White spot lesion index, visible plaque index and gingival bleeding index reported instead: MD 0.05 lower (0.10 lower to 0) white spot index, MD 0.09 lower (0.18 lower to 0) visible plaque index, MD 0.07 lower (0.15 lower to 0.01 higher) gingival bleeding index for 1400 ppm/250 ppm F (amine F/SnF) toothpaste/mouthrinse

‐

97
(1 RCT)

⊕⊝⊝⊝
VERY LOWa,b,c

The evidence is very uncertain about the effect of daily 1400 ppm/250 ppm F (amine F/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations on the white spot index, visible plaque index and on the gingival bleeding index in patients wearing fixed orthodontic braces

Number of participants with more severe DLs (severity of DLs)

None of the trials reported this outcome

Number of participants with adverse effects (adverse effects)

None of the trials reported this outcome

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; DLs: demineralised lesions; F: fluoride; MD: mean difference; NaF: sodium fluoride; ppm: parts per million; RCT: randomised controlled trial; SnF: stannous fluoride.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded 1 level due to single study assessed at unclear risk of bias (Ogaard 2006).
bDowngraded 1 level for indirectness (outcomes assessed were not the most useful for answering this question).
cDowngraded 1 level for imprecision (insufficient number of participants with new DLs (guideline 300 to 400)).

Figuras y tablas -
Table 2. Summary of findings for 1400 ppm/250 ppm F (amine F/SnF) toothpaste/mouthrinse compared to 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse for preventing early tooth decay (demineralised lesions) during fixed brace treatment
Ir a la tabla de la revisión
Table 3. Summary of findings for intraoral fluoride‐releasing glass bead device compared to 250 ppm F mouthrinse for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Patient or population: orthodontic patients (any age)
Setting: teaching hospital in UK and home use
Intervention: intraoral fluoride‐releasing glass bead device
Comparison: 250 ppm F mouthrinse

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

With 250 ppm F mouthrinse

With intraoral fluoride‐releasing glass bead device

Difference

Number of participants with new DLs (new DLs)

Assessed with: clinical intraoral photographs

Follow‐up: 19 months

36.80%

55.60%
(26.90 to 100)

18.80% more
(9.90 fewer to 77.40 more)

RR 1.51
(0.73 to 3.10)

37
(1 RCT)

⊕⊝⊝⊝
VERY LOWa,b

The evidence is very uncertain about the effect of intraoral fluoride‐releasing glass bead devices compared with daily 250 ppm F mouthrinses on the number of patients wearing a fixed orthodontic brace with new DLs

Number of participants with more severe DLs (severity of DLs)

None of the trials reported this outcome

Number of participants with adverse effects (adverse effects)

Follow‐up: 19 months

‐

‐

‐

‐

37
(1 RCT)

⊕⊝⊝⊝
VERY LOWa,b,c

Current design of fluoride glass bead inadequate. The authors write "an improved method of attachment is needed before it can be established whether FGBs (fluoride glass beads) are more effective than FR (fluoride mouthrinse)."c

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; DLs: demineralised lesions; F: fluoride; ppm: parts per million; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded 2 levels due to single study at high risk of bias (high attrition (47%)) (Luther 2005).
bDowngraded 1 level for imprecision (insufficient number of participants with new DLs (guidance 300 to 400 events)).
cHigh attrition partly due to breaks of the glass beads. The authors write "Some patients in the FGB (fluoride glass bead) group experienced a large number of bead breakages, resulting in a number of patients requesting to leave the trial." Numbers not supplied.

Figuras y tablas -
Table 3. Summary of findings for intraoral fluoride‐releasing glass bead device compared to 250 ppm F mouthrinse for preventing early tooth decay (demineralised lesions) during fixed brace treatment
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Comparison 1. Professionally‐applied F varnish versus non‐F (placebo) varnish

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with new DLs Show forest plot

2

405

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.14, 1.93]

2 Number of participants with more severe DLs (scores 3 or 4 versus scores 1 or 2) Show forest plot

1

148

Risk Ratio (M‐H, Random, 95% CI)

0.46 [0.22, 0.95]
Figuras y tablas -
Comparison 1. Professionally‐applied F varnish versus non‐F (placebo) varnish
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Comparison 2. 12,500 ppm F (NaF/olaflur/dectaflur) gel versus 0 ppm F placebo gel

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with new DLs Show forest plot

1

312

Risk Ratio (M‐H, Random, 95% CI)

0.99 [0.76, 1.27]
Figuras y tablas -
Comparison 2. 12,500 ppm F (NaF/olaflur/dectaflur) gel versus 0 ppm F placebo gel
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Comparison 3. 12,300 ppm F APF foam versus 0 ppm F placebo foam

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with new DLs Show forest plot

1

95

Risk Ratio (M‐H, Random, 95% CI)

0.26 [0.11, 0.57]
Figuras y tablas -
Comparison 3. 12,300 ppm F APF foam versus 0 ppm F placebo foam
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Comparison 4. 5000 ppm F toothpaste versus 1450 ppm F toothpaste

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with new DLs Show forest plot

1

380

Risk Ratio (M‐H, Random, 95% CI)

0.68 [0.46, 1.00]
Figuras y tablas -
Comparison 4. 5000 ppm F toothpaste versus 1450 ppm F toothpaste
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Comparison 5. 250 ppm F mouthrinse (100 ppm AmF/150 ppm NaF) versus 0 ppm F placebo mouthrinse

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with new DLs Show forest plot

1

81

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.37, 1.17]
Figuras y tablas -
Comparison 5. 250 ppm F mouthrinse (100 ppm AmF/150 ppm NaF) versus 0 ppm F placebo mouthrinse
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Comparison 6. 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 White spot index Show forest plot

1

97

Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.10, 0.00]

2 Visible plaque index Show forest plot

1

97

Mean Difference (IV, Random, 95% CI)

‐0.09 [‐0.18, ‐0.00]

3 Gingival bleeding index Show forest plot

1

97

Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.15, 0.01]
Figuras y tablas -
Comparison 6. 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations
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Comparison 7. Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with new DLs Show forest plot

1

173

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.69, 1.99]

2 Number of participants with more severe DLs of aesthetic concern Show forest plot

1

173

Risk Ratio (M‐H, Random, 95% CI)

1.18 [0.45, 3.12]
Figuras y tablas -
Comparison 7. Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC)
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Comparison 8. Intraoral F‐releasing glass bead device versus F mouthrinse only

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with new DLs Show forest plot

1

37

Risk Ratio (M‐H, Random, 95% CI)

1.51 [0.73, 3.10]
Figuras y tablas -
Comparison 8. Intraoral F‐releasing glass bead device versus F mouthrinse only
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