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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06131294
Other study ID # LL4470462
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2023
Est. completion date April 16, 2024

Study information

Verified date November 2023
Source Ivoclar Vivadent AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. The main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via QLF technology. Each patient will receive both treatments in a split-mouth design. It is comparison between an experimental fluoride application and Fluoride Protector S.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date April 16, 2024
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 13 Years to 50 Years
Eligibility Inclusion Criteria: - At least two active non-cavitated white spot lesions on buccal surfaces of anterior teeth or premolars (ICDAS code 1 and 2; Nyvad score 1) in two different quadrants. - Age between 13 and 50 years - No untreated caries lesions or periodontal disease - No systematic disease or medication (such as antidepressants, antibiotics etc.) that affects salivary flow rate - Subjects claimed regular brushing at least twice a day - Subjects had to agree to keep the scheduled recall appointments for at least 1 year. Exclusion Criteria: - Inactive non-cavitated lesions (Nyvad Score 4) - Lesions with microcavity, cavitation, chipping or discoloration - Lesions at buccal side of the molars - Lesions adjacent to restoration - Developmental white spot lesions such as enamel hypoplasia - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fluoride Application (Experimental Fluoride Application)
Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.
Fluor Protector S
Fluor Protector S is applied on white spot lesions.

Locations

Country Name City State
Turkey Istanbul Medipo University Istanbul Esenler

Sponsors (2)

Lead Sponsor Collaborator
Ivoclar Vivadent AG Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety Parameters Occurence of adverse device effects:
allergic reactions or irritations on mucosa
Baseline to 1 year
Primary White Spot Measurement Analysis of incipient caries or demineralized enamel by quantified results of delta F and delta R values (QLF technology). These values indicate the degree of demineralization. Baseline to 1 year
Secondary 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
Secondary Nyvad criteria Evaluation of the clinical status of the lesions:
0: Sound
Active caries (intact surface)
Active caries (surface discontinuity)
Active caries (cavity)
Inactive caries (intact surface)
Inactive caries (surface discontinuity)
Inactive caries (cavity)
Filling (sound surface)
Filling+active caries
Filling+inactive caries X: Extracted because of caries Lost because of caries
Baseline to 1 year
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