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
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
Scientific
Office 6
4th Floor
Institute of Dentistry
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom
 ORCID ID |
0000-0001-6841-227X |
|---|---|
| Phone | +44 (0)20 7882 6616 |
| a.s.johal@qmul.ac.uk |
Study information
| Study design | Interventional single center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The effectiveness of Bio-Min toothpaste in the management of white spot lesions: a randomized control trial |
| Study acronym | BMELT |
| Study objectives | A 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) studied | Enamel White Spot Lesions [WSL] |
| Intervention | Participants 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 type | Procedure/Surgery |
| Primary outcome measure | Remineralisation 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 measures | Time interval for remineralisation measured using the method described by Willmot et al., [2000] at 1, 3, 6 and 9 months |
| Overall study start date | 20/12/2019 |
| Completion date | 01/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/09/2021 |
| Date of final enrolment | 01/11/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Turner Street
London
E1 2AD
United Kingdom
Sponsor information
University/education
Joint Research Management Office
5 Walden Street
London
E1 2EF
England
United Kingdom
| Phone | +44 (0)20 7882 7275 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | It 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 plan | All 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.
