Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial.
Journal
European journal of orthodontics
ISSN: 1460-2210
Titre abrégé: Eur J Orthod
Pays: England
ID NLM: 7909010
Informations de publication
Date de publication:
23 06 2020
23 06 2020
Historique:
pubmed:
15
6
2019
medline:
30
9
2020
entrez:
15
6
2019
Statut:
ppublish
Résumé
Self-applied and professional fluorides are key elements to limit caries-related side-effects during orthodontic treatment with fixed appliances. To evaluate the effectiveness of a new fluoride varnish formula containing 1.5% ammonium fluoride in preventing white spot lesions (WSLs) in adolescents undergoing multi-bracket orthodontic treatment. The study employed a randomized controlled triple-blinded design with two parallel arms. One hundred eighty-two healthy adolescents (12-18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled. Informed consent was obtained from 166 patients and they were randomly allocated to a test or a placebo group (with aid of a computer program, generating sequence numbers in blocks of 15). In the test group, fluoride varnish was applied in a thin layer around the bracket base every sixth week during the orthodontic treatment, while patients in the placebo group received a varnish without fluoride. The intervention started at onset of the fixed appliances and continued until debonding. The endpoint was prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score. One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the placebo group (dropout rate 10.8%). The total prevalence of WSL's on subject level after debonding was 41.8% in the test group and 43.8% in the placebo group. The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1. The multicentre design with somewhat diverging routines at the different clinics may have increased risk for performance bias. No health-economic evaluation was carried out. Regular applications of an ammonium fluoride varnish reduced the prevalence of advanced WSL during treatment with fixed orthodontic appliances. ClinicalTrials.gov (NCT03725020). The protocol was not published before trial commencement.
Sections du résumé
BACKGROUND
Self-applied and professional fluorides are key elements to limit caries-related side-effects during orthodontic treatment with fixed appliances.
OBJECTIVE
To evaluate the effectiveness of a new fluoride varnish formula containing 1.5% ammonium fluoride in preventing white spot lesions (WSLs) in adolescents undergoing multi-bracket orthodontic treatment.
SUBJECTS AND METHODS
The study employed a randomized controlled triple-blinded design with two parallel arms. One hundred eighty-two healthy adolescents (12-18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled. Informed consent was obtained from 166 patients and they were randomly allocated to a test or a placebo group (with aid of a computer program, generating sequence numbers in blocks of 15). In the test group, fluoride varnish was applied in a thin layer around the bracket base every sixth week during the orthodontic treatment, while patients in the placebo group received a varnish without fluoride. The intervention started at onset of the fixed appliances and continued until debonding. The endpoint was prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score.
RESULTS
One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the placebo group (dropout rate 10.8%). The total prevalence of WSL's on subject level after debonding was 41.8% in the test group and 43.8% in the placebo group. The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1.
LIMITATIONS
The multicentre design with somewhat diverging routines at the different clinics may have increased risk for performance bias. No health-economic evaluation was carried out.
CONCLUSIONS
Regular applications of an ammonium fluoride varnish reduced the prevalence of advanced WSL during treatment with fixed orthodontic appliances.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov (NCT03725020).
PROTOCOL
The protocol was not published before trial commencement.
Identifiants
pubmed: 31197364
pii: 5518386
doi: 10.1093/ejo/cjz045
doi:
Substances chimiques
Cariostatic Agents
0
Fluorides, Topical
0
Fluorides
Q80VPU408O
Banques de données
ClinicalTrials.gov
['NCT03725020']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
326-330Informations de copyright
© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.