Randomized clinical study on the infiltration of enamel mineralization disorders

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009760

Enrollment

Registered

2016-03-22

Start date

2016-04-01

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

Interventions

Group 1: Evidence that the mineralisation defects (Fluorosis and/or Hypomineralisation)will be masked after infiltration. The Icon-Etch will be applied only one time. Group 2: Evidence that the miner

Eligibility

Sex/Gender

All

Age

6 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Fluorosis or Hypomineralisation(teeth: 15-25, 35-45) - Patient between 6 and 70 years - Written concern of the patients or patients and their legal guardians

Exclusion criteria

Exclusion criteria: - Allergies to ICON’s compounds - Teeth with enamel cavitations - Pregnancy or breastfeeding - Signals that the patient cannot follow the schedule of the study (e.g. uncooperative patients)

Design outcomes

Primary

Measure	Time frame
Success of defects ‘masking seven days after Infiltration. - standardized questionnaire before and after treatment - digital analysis of photographs before and after treatment.	—

Secondary

Measure	Time frame
Success of defects ‘masking seven days after Infiltration. Reevaluations will be performed every 6 months. - digital analysis of photographs	—

Countries

Germany

Contacts

Public ContactMarina Petrou

Klinik für Zahnerhaltung, Parodontologie und Präventive ZahnheilkundeUniversitätsklinikum der RWTH Aachen

mpetrou@ukaachen.de00492418088111

Outcome results

None listed

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