Clinical Evaluation of an Experimental Remineralization Product

NCT06166849 | Completed Results

• 1 other identifier: LL4182693
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion

Keywords

white spot lesion

Outcome Measures

Primary Outcomes (2)

• White Spot Measurement

  Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.

  Baseline to 1 Year

• 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 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

  Baseline to 1 Year

Study Arms (2)

Experimental Fluoride Application

EXPERIMENTAL

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

Device: Experimental Fluoride Application

Control Group

NO INTERVENTION

No Treatment

Interventions

Experimental Fluoride Application DEVICE

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

Experimental Fluoride Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Enamel detachment at the site of investigation
• Allergies (DoReMin)
• Chronic diseases

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator

Study Sites (1)

Iuliu Hatieganu, University of Medicine and Pharmacy

Cluj-Napoca, 400012, Romania

Location

Results Point of Contact

• Title: Head of Department Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Study Officials

• Ada Delean, Prof. Dr.

  Iuliu Hatieganu University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: March 28, 2023
• Primary Completion: May 31, 2024
• Study Completion: March 11, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Locations

RO (1)