Condition category
Oral Health
Date applied
13/05/2020
Date assigned
14/05/2020
Last edited
14/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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 September 2022

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

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ama Johal

ORCID ID

http://orcid.org/0000-0001-6841-227X

Contact details

Office 6
4th Floor
Institute of Dentistry
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom
+44 (0)20 7882 6616
a.s.johal@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 284589

Study information

Scientific title

The effectiveness of Bio-Min toothpaste in the management of white spot lesions: a randomized control trial

Acronym

BMELT

Study hypothesis

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

Not provided at time of registration

Study design

Interventional single center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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-month

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 trial start date

20/12/2019

Overall trial end date

30/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Undergone previous course of fixed appliance treatment
2. Pre-existing clinical evidence of either enamel structural defects, demineralised lesions or flourosis prior to commencement of treatment

Recruitment start date

01/10/2020

Recruitment end date

01/06/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7275
research.governance@qmul.ac.uk

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Industry

Funder name

BioMin Technologies Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/11/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/05/2020: Trial’s existence confirmed by Institute of Dentistry Queen Mary University of London.