Clinical Evaluation of an Experimental Remineralization Product

Ivoclar Vivadent

Status: Active, not recruiting

Conditions: White Spot Lesion

Treatments: Device: Experimental Fluoride Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06166849

LL4182693

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Experimental Fluoride Application

Experimental group

Description:

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

Treatment:

Device: Experimental Fluoride Application

No Treatment

No Intervention group