High-fluoride toothpaste or high fluoride mouthrinse to prevent white spot lesions in adolescent orthodontic patients – trial

iStock_000002259334XSmall braces on teeth

Early enamel demineralised lesions or white spot lesions are adverse effects of fixed-appliance orthodontic treatment. A Cochrane review update in 2019 (Dental Elf – 27th Nov 2019) identified 10 studies suggesting beneficial effects for high fluoride products on white spot lesions although the evidence was of low certainty.

The aim of this study was to compare the effect of high-fluoride toothpaste and high- fluoride mouth rinse for preventing white spot lesions (WSL) during orthodontic treatment.


Ethical approval was obtained but no protocol was registered. Patients aged 12- 20 attending a specialist orthodontic clinic for fixed appliance treatment on both arches were invited to participate. Patients were randomised to one of three groups, twice daily toothbrushing with 1450ppm fluoride toothpaste (Control), Twice daily toothbrushing with 5000ppm fluoride toothpaste (HFT group) or twice daily 900ppm fluoride rinse (FMR). The sample size was calculated as 76 patients per group including a 15% anticipated attrition rate. The main outcome was incidence of white spot lesions assessed on digital photographs by two examiners not involved with clinical data collection. Compliance was assessed at 12 months using a questionnaire.


  • 270 patients (175 females, 95 males) were recruited between 2010 – 2012.
  • There were 22 dropouts and 15 patients excluded for incomplete data leaving 248 for analysis.
  • The mean duration of treatment was 25.9 (± 9.1) months.
  • 236 of the 248 analysed patients (95.2%) self-reported compliance at 12 months.
  • The number of patients with WSLs at baseline and increase is shown in the table below.
  Baseline WSL No of patients (%) Patients with increase ≥ 1 WSL Patients with increase ≥ 2 WSL Patients with increase ≥ 3 WSL
Mouth rinse (FMR) 17 (21%) 47 (58.0%) 39 (48.1%) 29 (35.8%)
High fluoride paste (HFT) 22 (25.9%) 51 (60.0%) 44 (51.8%) 34 (40.0%)
Control 15 (18.3%) 64 (78.0%) 48 (58.5%) 37 (45.1%)
  • The number of patients with an increase of ≥1 WSL in the ‘aesthetic zone’, during orthodontic treatment, was significantly lower in the
    • HFT group compared to the control, Risk ratio (RR) = 0.77 (95%CI: 0.62 to 0.95) and
    • The FMR group compared to control, RR = 74 (95%CI: 0.60 to 0.92).
  • No adverse effects or harms were reported by the patients.


The authors concluded: –

A positive effect of high fluoride toothpaste and fluoride mouth rinse in preventing WSL on central incisors, lateral incisors, and canines during orthodontic treatment. WSL are still a problem during orthodontic treatment. Therefore, future randomized controlled clinical trials are needed to assess evidence-based guidelines for preventing WSL during orthodontic treatment.


The fieldwork for this randomised controlled trial was conducted some years ago. However, as the 2019 Cochrane review shows this is still an area where more evidence is required to improve our understanding for managing WSLs. This trial was not registered but is well reported following key elements of the CONSORT statement. The randomisation and allocation procedures are described but do present opportunities for improvement as noted by the authors . However, the baseline characteristics are well matched, and the outcome assessment was blind to the group allocation. The findings demonstrate a beneficial effect for both the HFT and FMR over the standard fluoride control paste. For teeth in the aesthetic zone (3-3 in the maxillary and mandibular arches) a statistically significant reduction in the proportion of patients with increase of ≥1 WSL.


Primary Paper  

Enerbäck H, Lövgren ML, Strömberg N, Westerlund A. Effect of high-fluoride toothpaste and mouth rinse on the prevention of demineralized lesions during orthodontic treatment: a randomized controlled trial. Eur J Orthod. 2023 Sep 18;45(5):477-484. doi: 10.1093/ejo/cjad044. PMID: 37524332.

Other references

Enerbäck H, Lingström P, Möller M, Nylén C, Ödman Bresin C, Östman Ros I, Westerlund A. Effect of a mouth rinse and a high-fluoride toothpaste on caries incidence in orthodontic patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2022 Jul;162(1):6-15.e3. doi: 10.1016/j.ajodo.2022.03.011. Epub 2022 Apr 28. PMID: 35491328.

Dental Elf – 27th Nov 2019

White spot lesions: Topical fluoride for prevention during fixed orthodontic treatment

Dental Elf – 7th Jun 2023

White spot lesions – treatment options

Dental Elf – 1st May 2023

Fluoride varnish for prevention of white spot lesions during orthodontic treatment


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