Clinical Evaluation of an Experimental Remineralization Product

Not Applicable

Active, not recruiting

• Conditions: White Spot Lesion
• Interventions: Device: Experimental Fluoride Application

• Registration Number: NCT06166849
• Lead Sponsor: Ivoclar Vivadent AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2024-05-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Fluoride Application	Experimental Fluoride Application	Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application)

Primary Outcome Measures

Name	Time	Method
ICDAS II visual scoring system (Codes)	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
White Spot Measurement	Baseline to 1 Year	Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.

Trial Locations

Locations (1)

Iuliu Hatieganu, University of Medicine and Pharmacy; 🇷🇴 Cluj-Napoca, Romania