Clinical Evaluation of an Experimental Remineralization Product

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2025-04-30

Brief Summary

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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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Detailed Description

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Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental Fluoride Application

Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application)

Group Type EXPERIMENTAL

Experimental Fluoride Application

Intervention Type DEVICE

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

No Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental Fluoride Application

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

Intervention Type DEVICE

Eligibility Criteria

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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