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OpenTrials
Completed

NCT Number: NCT06166849

Clinical Evaluation of an Experimental Remineralization Product

The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.

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Key information

Conditions

White Spot Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iuliu Hatieganu, University of Medicine and Pharmacy

Cluj-Napoca, 400012, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least two incipient carious lesions on the buccal or oral surface of a permanent tooth. Neighbouring teeth should not be in two different groups. There is no maximum amount of lesions.
  • Active caries lesion
  • Patient at risk of caries
  • Vital teeth

Exclusion criteria

  • Pregnancy
  • Enamel detachment at the site of investigation
  • Allergies (DoReMin)
  • Chronic diseases

Treatment and study plan

Experimental Fluoride Application

Device

The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions

Primary outcomes

  1. White Spot Measurement

    Time frame: Baseline to 1 Year

    Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.

  2. ICDAS II Visual Scoring System (Codes)

    Time frame: Baseline to 1 Year

    Evaluation of the clinical status of the lesions:

    0: Sound tooth surface: No evidence of caries after 5 sec air drying

    • First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying
    • Distinct visual change in enamel visible when wet, lesion must be visible when dry
    • Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying
    • Underlying dark shadow from dentin
    • Distinct cavity with visible dentin
    • Extensive (more than half the surface) distinct cavity with visible dentin

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

Registry information

Official study title

Clinical Study of Tooth Enamel Remineralization Using DoReMin Product

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 12, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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