Efficacy Evaluation of Two Different Fluoride Applications

NCT06131294 | Completed Results

• 1 other identifier: LL4470462
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

White Spot Lesion

Keywords

white spot lesion

Outcome Measures

Primary Outcomes (20)

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  Baseline

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  Baseline

• Measurement of White Spot Lesions by QLF Parameters: WSA

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)

  Baseline

• Measurement of White Spot Lesions by QLF Parameters: Delta Q

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q \- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)

  Baseline

• Measurement of White Spot Lesions by QLF Parameters: Delta R

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)

  Baseline

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  1 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  1 Month

• Measurement of White Spot Lesions by QLF Parameters: WSA

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)

  1 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta Q

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q \- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)

  1 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta R

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)

  1 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  6 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  6 Month

• Measurement of White Spot Lesions by QLF Parameters: WSA

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)

  6 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta Q

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q \- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)

  6 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta R

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)

  6 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  12 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)

  12 Month

• Measurement of White Spot Lesions by QLF Parameters: WSA

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)

  12 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta Q

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q \- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)

  12 Month

• Measurement of White Spot Lesions by QLF Parameters: Delta R

  Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)

  12 Month

Secondary Outcomes (8)

• Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)

  Baseline

• Severity and Activity of White Spot Lesions by Nyvad Criteria

  Baseline

• Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)

  Baseline to 1 month

• Severity and Activity Transition of White Spot Lesions by Nyvad Criteria

  Baseline to 1 month

• Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)

  Baseline to 6 month

Study Arms (2)

Expermental Fluoride Application

EXPERIMENTAL

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.

Device: Fluoride Application (Experimental Fluoride Application)

Fluor Protector S

ACTIVE COMPARATOR

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

Device: Fluor Protector S

Interventions

Fluoride Application (Experimental Fluoride Application) 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.

Expermental Fluoride Application

Fluor Protector S DEVICE

Fluor Protector S is applied on white spot lesions.

Fluor Protector S

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

Istanbul Medipo University

Istanbul, Esenler, 34230, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Fluoride Treatment

Intervention Hierarchy (Ancestors)

Fluoridation; Preventive Dentistry; Dentistry

Results Point of Contact

• Title: Team Leader Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Study Officials

• Burcu Gözetici, Dr.

  Istanbul Medipo University

  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

Model Details: Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 14, 2023
• Study Start: February 24, 2023
• Primary Completion: May 31, 2023
• Study Completion: April 16, 2024
• Last Updated: October 23, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-03

Locations

TU (1)