Efficacy Evaluation of Two Different Fluoride Applications

NCT ID: NCT06131294

Last Updated: 2025-10-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-24

Study Completion Date

2024-04-16

Brief Summary

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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.

Detailed Description

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Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Expermental Fluoride Application

The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.

Group Type EXPERIMENTAL

Fluoride Application (Experimental Fluoride Application)

Intervention Type DEVICE

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

The ammonium fluoride gel will be applied once on the white spot lesions.

Group Type ACTIVE_COMPARATOR

Fluor Protector S

Intervention Type DEVICE

Fluor Protector S is applied on white spot lesions.

Interventions

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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.

Intervention Type DEVICE

Fluor Protector S

Fluor Protector S is applied on white spot lesions.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role collaborator

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Burcu Gözetici, Dr.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medipo University

Locations

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Istanbul Medipo University

Istanbul, Esenler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LL4470462

Identifier Type: -

Identifier Source: org_study_id

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