Process evaluation of the infiltration technique for masking post-orthodontic caries lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005067

Enrollment

Registered

2013-07-02

Start date

2013-11-04

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: Infiltration of post-orthodontic caries lesions with Icon is an established treatment option. Patients included in this study will be treated with Icon and will be additionally subjected to t

Eligibility

Sex/Gender

All

Age

12 Years to 50 Years

Inclusion criteria

Inclusion criteria: WSL following orthodontic treatment with fixed appliances of teeth 14 to 24 and 34 to 44, lesions with ICADS code 2, written consent of the patient or legal guardian.

Exclusion criteria

Exclusion criteria: Allergies to any of the used materials, lesions with cavitation of the enamel, debonding performed more than 12 months, pregnancy or lactation, or assumption that the patient will not comply with the protocol.

Design outcomes

Primary

Measure	Time frame
Analysis of a correlation between time to achieve a ?E of 4 by “rewetting” (t?E4, analysis with Adobe Photoshop©) and the results of masking the lesion with infiltration (?Enach). Analysis of a correlation between numbers of required etching procedures (nEtch) and time since debonding (tdeb) in terms of achieving similar masking results.	—

Secondary

Measure	Time frame
Proof that the infiltration procedure is able to mask the WSL. This includes the reduction of the colour difference ?E below the visible threshold of ?E = 3.7 in a distance of 50 cm and a change from ICDAS 2 to ICDAS 1 or 0. Evaluation of parameters (?F, ?Q) measured with the Quantitative Light-induced Fluorescence (QLF) before and after infiltration. Evaluation of long term results (3 years) and proof that the cosmetic improvement following infiltration remains consistent throughout the observation period (variables: ICDAS+Act., ?E, ?F, ?Q; Follow up after 1 week, 6 months, 1year, 2 years and 3 years). Measurement of the enamel volume (Venamel) lost due to etching prior to infiltration. Evaluation of patient satisfaction (Z) before treatment and during follow up (1 week, 6 months, 1 year, 2 years, 3 years) concerning overall cosmetic results, treatment comfort and oral health related quality of life with questionnaires (modified COHQOL, OHIP14 and OIPD).	—

Measure

Time frame

Proof that the infiltration procedure is able to mask the WSL. This includes the reduction of the colour difference ?E below the visible threshold of ?E = 3.7 in a distance of 50 cm and a change from ICDAS 2 to ICDAS 1 or 0. Evaluation of parameters (?F, ?Q) measured with the Quantitative Light-induced Fluorescence (QLF) before and after infiltration. Evaluation of long term results (3 years) and proof that the cosmetic improvement following infiltration remains consistent throughout the observation period (variables: ICDAS+Act., ?E, ?F, ?Q; Follow up after 1 week, 6 months, 1year, 2 years and 3 years). Measurement of the enamel volume (Venamel) lost due to etching prior to infiltration. Evaluation of patient satisfaction (Z) before treatment and during follow up (1 week, 6 months, 1 year, 2 years, 3 years) concerning overall cosmetic results, treatment comfort and oral health related quality of life with questionnaires (modified COHQOL, OHIP14 and OIPD).

—

Countries

Germany

Contacts

Public ContactHendrik Meyer-Lückel

Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde Universitätsklinikum Aachen

hmeyer-lueckel@ukaachen.de0241/8088110

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026