MedTrace Logo

Clinical Evaluation of an Experimental Remineralization Product

NCT06166849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-03-27

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • White Spot Lesion

Interventions

DEVICE

Experimental Fluoride Application

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

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    collaborator OTHER

  • Ivoclar Vivadent AG

    lead INDUSTRY

Principal Investigators

  • Ada Delean, Prof. Dr. · Iuliu Hatieganu University of Medicine and Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2024-05-31
Completion
2025-03-11

Countries

  • Romania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06166849 on ClinicalTrials.gov