Clinical trial for masking of dental fluorosis by infiltratio

Phase 4

• Conditions: K00.3; K03.6; Mottled teeth; Deposits [accretions] on teeth

• Registration Number: DRKS00010465
• Lead Sponsor: Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltung und Parodontologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-26
• Study Completion: 2017-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Light to moderate fluorotic lesions during mineralisation of the teeth 15 to 25 and 35 to 45 (TF Index = 1-5)
• Male and female patients of 18+ years at the time of recruitment
• Legal competence
• A written informed consent of the subject/patient to apply to the study voluntarily is mandatory

Exclusion Criteria

• Attendance to other interventional examinations
• Contraindications in accordance with prescribing information or package information
• Allergies towards one of the contents or contact allergies
• Severe general diseases (ASA > 1)
• Previous restorative treatment of the fluorotic enamel areas of the teeth 15-25 and 35-45
• Bleaching of the teeth 15-25 and 35-45 within the last 18 months [Auschill TM, Schneider-Del Savio T, Hellwig E, Arweiler NB 2012]
• Evidence of the participating person presumably not following the study protocol (e.g. lack of cooperativeness)
• Accommodation in an institution due to court injunction or official arrangement

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Reduction of the color difference ?E between fluorotic lesions and healthy enamel immediately after treatment (1 hour after completion of infiltration) in comparison to the initial situation (difference). The treatment results are evaluated photo-optically with standardized photographs and subsequent digital photo analysis (ImageJ). <br>For photo-optical analysis an index tooth is determined. The index tooth shows the most servere dental fluorosis. By using the formula ?E = ((?L*)2+(?a*)2+(?b*)2)1/2 , the color difference can be calculated.

Secondary Outcome Measures

Name	Time	Method
•Reduction of the color difference ?E below the limit of a normal conversation distance visible to the human eye according to ?E = 3.7 [Johnston and Kao 1989] (1 hour after completion of infiltration)<br>•Patient satisfaction (PZ) + OHIP 14 according to the overall aesthetic result and the treatment comfort (1 hour after completion of infiltration)<br>•Long-term results; Improvements after treatment during the observation period (1, 3, 6 months) (variables: ?E and optical assessment by non-specialist judge; PZ)<br>•Accordance of the colorimeter VITA Easyshade V's ?E value and the standardized, digital photographs evaluated by ImageJ