White Spot Lesions [Initial Caries] on Smooth Surface of ToothNCT07730359
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
A study testing Varnish in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Mintech Bio Ltd at 1 site in United Kingdom.
Trial summary
Mintech-Bio Ltd is a UK-based start-up company which was created to turn 14 years of research from our co-founder Dr Alvaro Mata at Queen Mary University into a real-world product. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
- What is being tested?
- Varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • Will have dental braces or brackets removed immediately prior to or up to 48 hours prior to potential study participation
- Have at least one active non-cavitated carious lesions around the bracket area with a rough, chalky and matte surface (white spot lesions - WSLs) at each side of the mouth;
- Have carious lesion which are fully visible, assessable and accessible;
- Are able and willing to observe good oral hygiene throughout the study;
- Have ≥20 teeth and a BPE score of <3;
- Have completed fixed orthodontic treatment within the past 24-120 hours.
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- Are aged 12-60 years
- Are willing and able to attend the on-study visits;
- Are willing and able to understand all study-related procedures;
- Provide written informed consent (by parent/guardian if minor) before participation in the study.
- No systemic diseases or concomitant medication affects salivary flow in order not to negatively affect the remineralising process.
Who cannot join
- • Patients with known hypersensitivity to glutaraldehyde or any of the product's ingredients.
- Patients with severe pulpitis or oral infections
- Patients who are still be undergoing treatment using dental braces or brackets at time of study initiation
- Patients who are vulnerable
- Patients who are participating in another trial
- Patients with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia
- Participants who had evidence of reduced salivary flow, systemic, or medical complications
- Participants with cavitated lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences, Kings College London
London, SE1 9RT
Avijiit Professor of Cariology & Operative Dentistry, +44 207 1881577, avijit.banerjee@kcl.ac.uk
About this study
Official title: A Pilot Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
Mintech-Bio Ltd is a UK-based start-up company which was created to turn 14 years of research from our co-founder Dr Alvaro Mata at Queen Mary University into a real-world product.
Loss of tooth enamel from issues such as decay or erosion is a great cause of dental problems, affecting over half of people around the world. There is also evidence to suggest that having poor oral health may be connected to other health issues such as diabetes, heart problems, and lung infections like pneumonia.
Read more
While treatments like fluoride varnishes and remineralization solutions can help with the effects of enamel loss, there's currently no easy-to-use option that actually regrows enamel in a way that closely matches the natural look and strength of real enamel.
Mintech-Bio has created a special gel that helps rebuild tooth enamel back to its natural strength and structure. This new invention could take the place of fluoride treatments and make a big difference in preventing tooth problems around the world. The purpose of this research study is to demonstrate the efficacy of the Epinamel device in the treatment of dental white-spot lesions.
If you meet all the screening criteria you will be entered into the study and shall have the device applied after the removal of dental braces. Each trial participant will have the treatment product applied to a tooth on one side of the mouth, and a comparative 'control' product named Curodont Repair (vVardis Professional, Switzerland will be applied on the opposite side of the mouth.
- Being tested
- Varnish
- Keywords
- intial caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VarnishDevice
Epinamel is a professional dental product that is indicated for the treatment of white spot lesions. It utilizes a patented technology that promotes enamel repair by entrapping calcium and phosphate from the saliva to grow hydroxyapatite mineral within the white spot lesion and on the tooth surface.
Epinamel is a 2-part product. Applying and drying Part A on the surface of the tooth followed by Part B initiates the hardening and setting of the product.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Epinamel one side of mouth Curadont opposite side of mouth Receives: Device: Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry.
Classified as the proportion of lesions that:
Regress (decrease in size by >20% at 6 weeks with respect to baseline), Progress (increase in size by >20% at 6 weeks with respect to baseline), or Remain approximately stable in size (decrease or increase in size by ≤20% at 6 weeks with respect to baseline).
Assessment method: Morphometric measurement (micrometers) of standardized, calibrated clinical photographs.
Measured: 6 weeks
Secondary outcomes (1)
Laser Fluorescence Readings (DIAGNOdent Pen, KaVo, Biberach, Germany) Objective fluorescence-based assessment of lesion status.
Repeat measurements will be used to monitor lesion progression or regression over time.
Numerical values range from 0 to 99, with clinical interpretation as follows:
0-12: Healthy tooth structure / sound enamel 13-24: Initial enamel caries / demineralization 25-29: Deep enamel caries, possible dentin involvement
≥30: Likely dentin caries / advanced lesion
A two-sided paired samples t-test will be used to compare laser fluorescence measurements at baseline and 6 weeks following treatment. A p-value of <0.05 will be considered statistically significant
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start6 Jul 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesions [Initial Caries] on Smooth Surface of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mintech Bio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730359
- Sponsor's protocol ID
- CIP01_Rev01
- Other IDs
- 10072636
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
- ClinicalTrials.gov ID
- NCT07730359
- Acronym / sponsor ID
- CIP01_Rev01
- Keywords
- intial caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mintech Bio LtdIndustry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mintech-Bio Ltd is a UK-based start-up company which was created to turn 14 years of research from our co-founder Dr Alvaro Mata at Queen Mary University into a real-world product.
Loss of tooth enamel from issues such as decay or erosion is a great cause of dental problems, affecting over half of people around the world. There is also evidence to suggest that having poor oral health may be connected to other health issues such as diabetes, heart problems, and lung infections like pneumonia.
While treatments like fluoride varnishes and remineralization solutions can help with the effects of enamel loss, there's currently no easy-to-use option that actually regrows enamel in a way that closely matches the natural look and strength of real enamel.
Mintech-Bio has created a special gel that helps rebuild tooth enamel back to its natural strength and structure. This new invention could take the place of fluoride treatments and make a big difference in preventing tooth problems around the world. The purpose of this research study is to demonstrate the efficacy of the Epinamel device in the treatment of dental white-spot lesions.
If you meet all the screening criteria you will be entered into the study and shall have the device applied after the removal of dental braces. Each trial participant will have the treatment product applied to a tooth on one side of the mouth, and a comparative 'control' product named Curodont Repair (vVardis Professional, Switzerland will be applied on the opposite side of the mouth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: VarnishEpinamel one side of mouth Curadont opposite side of mouth |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- • Will have dental braces or brackets removed immediately prior to or up to 48 hours prior to potential study participation
Key exclusion criteria (8 listed)
- • Patients with known hypersensitivity to glutaraldehyde or any of the product's ingredients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VarnishEpinamel is a professional dental product that is indicated for the treatment of white spot lesions. It utilizes a patented technology that promotes enamel repair by entrapping calcium and phosphate from the saliva to grow hydroxyapatite mineral within the white spot lesion and on the tooth surface. Epinamel is a 2-part product. Applying and drying Part A on the surface of the tooth followed by Part B initiates the hardening and setting of the product. | Device | Treatment group |
Primary outcome
Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry.
Time frame: 6 weeks
Classified as the proportion of lesions that: Regress (decrease in size by >20% at 6 weeks with respect to baseline), Progress (increase in size by >20% at 6 weeks with respect to baseline), or Remain approximately stable in size (decrease or increase in size by ≤20% at 6 weeks with respect to baseline). Assessment method: Morphometric measurement (micrometers) of standardized, calibrated clinical photographs.
1 secondary outcome
Laser Fluorescence Readings (DIAGNOdent Pen, KaVo, Biberach, Germany) Objective fluorescence-based assessment of lesion status.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varnish in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Mintech Bio Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Clinical Consultant (+44 7541619940, christina@cslifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.