Infiltration of White-spot lesions during multibracket appliance treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027344

Enrollment

Registered

2022-08-05

Start date

2022-09-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K02.0

Interventions

Group 1: Intervention 1: Instructions regarding home oral hygiene and nutrition Intervention2: Infiltration of the WSL Icon verst.® Group 2: Intervention 1: Instructions regarding home oral hygiene a

Eligibility

Sex/Gender

All

Age

12 Years to 17 Years

Inclusion criteria

Inclusion criteria: The inclusion requirements are at least one tooth with WSL (ICDAS value 1 to 2) in the labial region of the right canine to the left canine of the maxilla and the mandible. If more than one tooth is affected in a study participant, all affected teeth are included in the treatment. And metal braces

Exclusion criteria

Exclusion criteria: Participants with cavitated lesions, proximal caries, filled and restored teeth, enamel abnormalities (e.g., fluorosis, MIH), gingivitis, or allergies to any of the materials used will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: - Color difference (?E) between adjacent healthy enamel and WSL after 6 months. Using standardized digital photographs (Canon SLR camera) and Photoshop Adobe CS6 image processing software, Adobe (San Jose, USA), the color differences ?E (color and brightness) between adjacent healthy enamel and WSL are quantitatively determined according to the Commission Internationale de l'Eclairage (CIE) system.	—

Measure

Time frame

Primary endpoint: - Color difference (?E) between adjacent healthy enamel and WSL after 6 months. Using standardized digital photographs (Canon SLR camera) and Photoshop Adobe CS6 image processing software, Adobe (San Jose, USA), the color differences ?E (color and brightness) between adjacent healthy enamel and WSL are quantitatively determined according to the Commission Internationale de l'Eclairage (CIE) system.

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Secondary

Measure	Time frame
-Color difference (?E) before infiltration/fluoridation, after 1 week and after 1, 3, 12, 24 and 36 months. - Caries determination: determination by ICDAS (International Caries Detection Assessment System) on all surfaces of the teeth at each examination, as this is a prevention program. It is very important to continuously monitor both the affected teeth and the rest of the teeth. - Oral hygiene: determination with the help of the caries risk evaluation, gingivitis: BOP (Bleeding On Probing), PSI (Periodontal Screening Index). - Concentration of bisphenol A in saliva: Very small amounts of bisphenol A appear in saliva after treatment with Icon vestibular. This phenomenon occurs shortly after application of the material.	—

Measure

Time frame

-Color difference (?E) before infiltration/fluoridation, after 1 week and after 1, 3, 12, 24 and 36 months. - Caries determination: determination by ICDAS (International Caries Detection Assessment System) on all surfaces of the teeth at each examination, as this is a prevention program. It is very important to continuously monitor both the affected teeth and the rest of the teeth. - Oral hygiene: determination with the help of the caries risk evaluation, gingivitis: BOP (Bleeding On Probing), PSI (Periodontal Screening Index). - Concentration of bisphenol A in saliva: Very small amounts of bisphenol A appear in saliva after treatment with Icon vestibular. This phenomenon occurs shortly after application of the material.

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Countries

Germany

Contacts

Public ContactYamen Kashash

Charité - Universitätsmedizin Berlin Abteilung für Kieferorthopädie und Orthodontie

yamen.kashash@charite.de030/ 450 562 587

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026