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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06166849
Other study ID # LL4182693
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 28, 2023
Est. completion date April 30, 2025

Study information

Verified date April 2024
Source Ivoclar Vivadent AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date April 30, 2025
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Romania Iuliu Hatieganu, University of Medicine and Pharmacy Cluj-Napoca

Sponsors (2)

Lead Sponsor Collaborator
Ivoclar Vivadent AG Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary White Spot Measurement Analysis of incipient caries or demineralized enamel by using laser fluorescence technology. Baseline to 1 Year
Primary ICDAS II visual scoring system (Codes) Evaluation of the clinical status of the lesions:
0: Sound tooth surface: No evidence of caries after 5 sec air drying
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
Distinct visual change in enamel visible when wet, lesion must be visible when dry
Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying
Underlying dark shadow from dentin
Distinct cavity with visible dentin
Extensive (more than half the surface) distinct cavity with visible dentin
Baseline to 1 Year
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