How effective are toothpastes in improving tooth discoloration marks after brace treatment?

ISRCTN ISRCTN14479873
DOI https://doi.org/10.1186/ISRCTN14479873
IRAS number 284589
Secondary identifying numbers IRAS 284589
Submission date
13/05/2020
Registration date
14/05/2020
Last edited
13/05/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Young people undergo orthodontic treatment to improve the appearance of their teeth, smile and bite. It is therefore very sad to see so many of these teeth become harmed during brace treatment, leaving a permanent and visible mark, which becomes very easy to see after brace removal. Toothpaste is recommended and used daily and therefore remains a relatively easy method of improving the appearance of the teeth by lessening the visibility of these marks. Whilst traditional Fluoride containing toothpastes have been shown to have some beneficial effects, newer toothpastes which contain lower levels of fluoride but a greater potential to release this in a more gradual way, offer the possibility of greater improvements in reducing these defects in the teeth. We aim to assess how brushing your teeth with one of two different types of toothpaste can affect the appearance of the white spots defects, known as white spot lesions (WSL), that have developed on the teeth and become visible following the removal of your fixed brace.

Who can participate?
Adolescents [12-18 years], who have undergone a minimum of 12-months of fixed appliance treatment in both arches, with clinically identifiable WSL present on at least 1 of the maxillary and/or mandibular anterior teeth [first premolar to first premolar] at the time of removal of fixed orthodontic appliances.

What does the study involve?
Participants will be randomly allocated to receive intervention care (Bio-Min toothpaste) or standardised care (Conventional toothpaste) and will be assessed for the level of remineralisation at 1, 3, 6 and 9 months.

What are the possible benefits and risks of participating?
The benefits are that it will help us to better understand which toothpaste is more effective in improving the appearance of the white spot defects on the teeth. There are no expected risks to taking part in this study.

Where is the study run from?
Institute of Dentistry, Queen Mary, University of London (UK)

When is the study starting and how long is it expected to run for?
December 2019 to March 2026

Who is funding the study?
BioMin Technologies Limited (UK)

Who is the main contact?
Prof Ama Johal, a.s.johal@qmul.ac.uk

Contact information

Prof Ama Johal
Scientific

Office 6
4th Floor
Institute of Dentistry
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom

ORCiD logoORCID ID 0000-0001-6841-227X
Phone +44 (0)20 7882 6616
Email a.s.johal@qmul.ac.uk

Study information

Study designInterventional single center randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe effectiveness of Bio-Min toothpaste in the management of white spot lesions: a randomized control trial
Study acronymBMELT
Study objectivesA fluoride containing bioactive glass toothpaste does not lead to a greater reduction in visible post-orthodontic WSL compared with a standard toothpaste.
Ethics approval(s)Approved 06/09/2021, Wales Research Ethics Committee 6 Swansea (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 2922 941090; Wales.REC6@wales.nhs.uk), ref: 21/WA/0256
Health condition(s) or problem(s) studiedEnamel White Spot Lesions [WSL]
InterventionParticipants will be randomly assigned, using computer generated numbers, blindly to intervention care (Bio-Min toothpaste) or standardised care (Conventional toothpaste), and assessed for the level of remineralisation at 1-, 3-, 6- and 9-months.
Intervention typeProcedure/Surgery
Primary outcome measureRemineralisation of WSL measured using the method described by Willmot et al., [2000] as % change from baseline at 1, 3, 6 and 9 months
Secondary outcome measuresTime interval for remineralisation measured using the method described by Willmot et al., [2000] at 1, 3, 6 and 9 months
Overall study start date20/12/2019
Completion date01/03/2026

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit12 Years
Upper age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Age 12-18 years
2. Undergone a minimum of 12-months of fixed appliance treatment in both arches
3. Clinically identifiable WSL present on at least 1 of the maxillary and/or mandibular anterior teeth [first premolar to first premolar] at the time of removal of fixed orthodontic appliances
Key exclusion criteria1. Undergone previous course of fixed appliance treatment
2. Pre-existing clinical evidence of either enamel structural defects, demineralised lesions or fluorosis prior to commencement of treatment
Date of first enrolment01/09/2021
Date of final enrolment01/11/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen Mary University of London
Institute of Dentistry
Turner Street
London
E1 2AD
United Kingdom

Sponsor information

Queen Mary University of London
University/education

Joint Research Management Office
5 Walden Street
London
E1 2EF
England
United Kingdom

Phone +44 (0)20 7882 7275
Email research.governance@qmul.ac.uk
Website http://www.qmul.ac.uk/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Industry

BioMin Technologies Limited

No information available

Results and Publications

Intention to publish date01/03/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planIt is intended that the results of the research would be presented at conferences or organising/attending workshops. In addition, the results can be published in peer-review journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No
Protocol article 10/09/2024 11/09/2024 Yes No

Editorial Notes

13/05/2025: The following changes were made:
1. The recruitment end date was changed from 01/05/2025 to 01/11/2025.
2. The overall study end date was changed from 01/11/2025 to 01/03/2026.
11/09/2024: Publication reference added.
14/05/2024: The following changes were made:
1. The recruitment end date was changed from 01/05/2024 to 01/05/2025.
2. The overall study end date was changed from 01/11/2024 to 01/11/2025.
3. The intention to publish date was changed from 01/03/2025 to 01/03/2026.
10/05/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/05/2023 to 01/05/2024.
2. The overall study end date was changed from 01/11/2023 to 01/11/2024.
3. The intention to publish date was changed from 01/12/2023 to 01/03/2025.
4. The plain English summary was updated to reflect these changes.
5. The ethics approval was added.
20/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2022 to 01/05/2023.
2. The overall trial end date was changed from 30/09/2022 to 01/11/2023.
3. The intention to publish date was changed from 01/11/2022 to 01/12/2023.
08/06/2021: The recruitment start date was changed from 01/06/2021 to 01/09/2021.
02/12/2020: The recruitment start date was changed from 01/12/2020 to 01/06/2021.
16/10/2020: The recruitment start date was changed from 01/10/2020 to 01/12/2020.
14/05/2020: Trial’s existence confirmed by Institute of Dentistry Queen Mary University of London.