Clinical Evaluation of an Experimental Remineralization Product

March 6, 2026 updated by: Ivoclar Vivadent AG

Clinical Study of Tooth Enamel Remineralization Using DoReMin 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Cluj-Napoca, Romania, 400012
        • Iuliu Hatieganu, University of Medicine and Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Fluoride Application
Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application)
Device: Experimental Fluoride Application
The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
No Intervention: Control Group
No Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White Spot Measurement
Time Frame: Baseline to 1 Year
Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.
Baseline to 1 Year
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

  1. 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
  2. Distinct visual change in enamel visible when wet, lesion must be visible when dry
  3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying
  4. Underlying dark shadow from dentin
  5. Distinct cavity with visible dentin
  6. Extensive (more than half the surface) distinct cavity with visible dentin
Baseline to 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivoclar Vivadent AG

Collaborators

Iuliu Hatieganu University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Ada Delean, Prof. Dr., Iuliu Hatieganu University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

March 11, 2025

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LL4182693

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on White Spot Lesion

Clinical Trials on Experimental Fluoride Application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe