Clinical Evaluation of an Experimental Remineralization Product

White Spot Lesion Clinical Trial

Official title:

Clinical Study of Tooth Enamel Remineralization Using DoReMin Product

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06166849
• Other study ID #: LL4182693
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• White Spot Lesion

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