RecruitingNAINTERVENTIONAL

Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions

This study is looking into a new gel called Epinamel, developed by Mintech-Bio Ltd, which aims to regrow tooth enamel. Losing enamel can cause many dental problems, and current treatments don't always fully restore teeth to their natural look and strength. Epinamel is designed to rebuild enamel and could become a new way to prevent tooth problems. Specifically, the study will test how effective Epinamel is at treating 'white spot lesions' – discoloured areas on teeth often seen after braces are removed. Participants will have Epinamel applied to one side of their mouth and a different product, Curodont Repair, to the other side to compare their effects. This research hopes to show Epinamel can help restore teeth closer to their natural state.

At a glance

Status

Recruiting

Phase

Sponsor

Mintech Bio Ltd

Enrolment target

Start

06 Jul 2026

Estimated completion

31 Jan 2027

White Spot Lesions [Initial Caries] on Smooth Surface of Tooth

What is this study about?

You've probably heard that healthy teeth are really important, not just for chewing but for your overall health too. Sometimes, things like decay or erosion can cause us to lose tooth enamel, which is the hard, protective outer layer of our teeth. This can lead to dental problems, and some research even suggests poor mouth health might be linked to other health conditions like diabetes or heart issues.

Currently, we have treatments like fluoride varnishes that can help, but they don't really 'regrow' enamel in a way that matches the look and feel of natural teeth. That's where Mintech-Bio Ltd comes in. They are a UK company that has developed a special gel called Epinamel. This gel is designed to help rebuild lost tooth enamel, aiming to bring back its natural strength and structure. They hope this new approach could eventually replace some existing fluoride treatments and make a big difference in preventing tooth problems worldwide.

This specific study focuses on 'white spot lesions.' These are often chalky, discoloured patches on teeth, sometimes seen after dental braces are removed. The main goal of this research is to see how well Epinamel works on these white spots. They'll be comparing it to another product called Curodont Repair to understand if Epinamel is a more effective way to make these areas look more natural and healthy.

Key takeaways

Tests a new gel (Epinamel) to regrow tooth enamel.
Aims to treat 'white spot lesions' after braces.
Compares Epinamel to another treatment (Curodont Repair).
Focuses on restoring natural tooth strength and appearance.
Could offer a new way to prevent global tooth problems.

Who may be eligible?

To be part of this study, you generally need to be between 12 and 60 years old and have recently had your dental braces removed (within 24 to 120 hours before potentially joining). You should have at least one active 'white spot lesion' (those chalky, rough spots) in the area where your braces were, on both sides of your mouth, and these spots need to be easily seen and reached.

You also need to be committed to looking after your dental hygiene throughout the study and be able to attend all the required appointments. It's important that you or your parent/guardian are willing to give written permission to take part, and you shouldn't have any major health problems or medications that could affect your saliva flow or any severe infections in your mouth.

Fewer people will be able to join if they have allergies to certain ingredients in the product, are currently in another trial, or have certain dental conditions like severe discolouration from other causes, or if their white spots have turned into cavities. The study also cannot include vulnerable people or those with reduced saliva flow.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 12 and 60 years old?
Have you had your braces removed within the last 5 days?
Do you have white spots on your teeth where your braces were, on both sides of your mouth?
Are you able and willing to attend all study appointments?
Do you have good overall dental and general health?

Answer every question to see your result.

What does participation involve?

If you meet all the criteria and are selected, the study will involve applying the special gel. This will happen shortly after your dental braces are removed. One side of your mouth will receive the new Epinamel gel, and the opposite side will receive the comparison product, Curodont Repair. You will need to take good care of your mouth throughout the study and attend all the planned follow-up appointments. The study will involve several visits to the clinic to check on the progress of the white spots and how well the gels are working. The total duration of your participation will depend on the study's follow-up schedule, which will be explained in detail before you agree to join.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially effective treatment for white spot lesions that aims to restore your enamel. This could improve the appearance and health of your teeth. However, as with any study, there could be risks. These are expected to be minimal, but might include short-term discomfort or sensitivity. All potential risks will be fully explained before you agree to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences, Kings College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are 'white spot lesions'?

These are chalky, discoloured patches on the surface of your teeth, often seen after braces are removed, which are an early sign of enamel weakness.

What is Epinamel?

Epinamel is a new gel designed to help regrow and rebuild lost tooth enamel, aiming to restore its natural strength and look.

Will I get both treatments?

Yes, you will have Epinamel applied to a tooth on one side of your mouth and a comparison product (Curodont Repair) on the other side.

Who is running this study?

The study by Mintech-Bio Ltd, a UK start-up, in collaboration with research from Queen Mary University, London.

Do I have to pay to join?

No, you will not have to pay to participate in a clinical trial. All treatments and study-related assessments will be provided free of charge.

How to find out more

Gabriella Research Portfolio Manager

gabriella.wojewodka@kcl.ac.uk +44 20 7848 5958 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.