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

Not Applicable

Conditions: K02.0
Caries limited to enamel

Registration Number: DRKS00005067

Lead Sponsor: Klinik für Zahnerhaltung, Parodontologie und Präventive ZahnheilkundeUniklinikum Aachen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 28

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>Analysis of a correlation between numbers of required etching procedures (nEtch) and time since debonding (tdeb) in terms of achieving similar masking results.<br>

Secondary Outcome Measures

Name	Time	Method
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.<br>Evaluation of parameters (?F, ?Q) measured with the Quantitative Light-induced Fluorescence (QLF) before and after infiltration.<br>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).<br>Measurement of the enamel volume (Venamel) lost due to etching prior to infiltration.<br>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).<br>