Abstract
BACKGROUND: White spot lesions (WSL) are common side effects of orthodontic treatment with fixed appliances, in which the surface layer of enamel is demineralised. Thus, remineralisation, that is a partial or complete reversal, of these lesions can occur as they affect the surface enamel. Remineralisation with low-dose fluoride, in addition to optimal oral hygiene and diet, has been recommended to manage WSL. The aim of the planned trial is to assess the effectiveness of a fluoride-containing bioactive glass toothpaste (BioMin™) in its ability to remineralise post-orthodontic demineralised WSL. METHODS: A single-centre, double-blind randomised clinical trial to assess intervention with Bio-Min toothpaste on WSL forming on the teeth of young people completing orthodontic treatment. DISCUSSION: Remineralisation of WSL can vary depending on the individual and the site of the lesion. There is a range of oral fluoride delivery methods which include toothpastes, oral rinses, and gel preparations, which can aid remineralisation of these lesions. Identifying effective methods of remineralisation to manage this common and unsightly complication of fixed appliance therapy can improve the health and aesthetics of dentition. TRIAL REGISTRATION: ISRCTN.com International Standard Randomised Controlled Trials Number (ISRCTN) 14479893 . Registered on 14 May 2020.