CompletedNot Applicable

Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam

Italy40 participantsStarted 2024-05-01

Plain-language summary

To evaluate the efficacy of enamel remineralization by biomimetic hydroxyapatite contained in microRepair-based Biorepair Total Protection toothpaste compared to the use of Bio Enamel Caries and Erosion toothpaste based on Fluoro-Hydroxyapatite and BioActive Complex, evaluated with Diagnodent Pen and Diagnocam.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * First permanent molars erupted and completely healthy * Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen Exclusion Criteria: * Patients with Diagnodent-stimulated value \> 25 * Patients with groove sealings of sealed permanent first molars or composite restorations * First molars with extensive demineralizations (Molar Incisor Hypomineralization, fluorosis, white/brown spots)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Diagnodent Pen value

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Diagnocam value

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Schiff Air Index

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Bleeding on Probing

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Plaque Index

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Basic Erosive Wear Examination

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Trial details

NCT IDNCT06425536

SponsorUniversity of Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-25

View on ClinicalTrials.gov More Enamel Caries trials

Plain-language summary

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Diagnodent Pen value

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Diagnocam value

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Schiff Air Index

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Bleeding on Probing

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Plaque Index

Timeframe: Study begin, 1, 3 and 6 months after the baseline

Change in Basic Erosive Wear Examination

Timeframe: Study begin, 1, 3 and 6 months after the baseline