Trial document




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  DRKS00010465

Trial Description

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Title

Clinical trial for masking of dental fluorosis by infiltration

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Trial Acronym

FIT-Research Study 2016 (Fluorose-Infilrtation-Technique)

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URL of the Trial

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Brief Summary in Lay Language

The study aims to demonstrate the masking effect (reduction in color difference) by resin infiltration of mild to moderately severe tooth fluorosis. The ultimate objective of this fluorosis therapy is an appearance improvement of the teeth in the aesthetic region. Fluorosis is the most common cause of internal tooth discoloration and provides an insufficient mineralization of the enamel due to excessive fluoride intake (> 0.05 mg / kg / bw / d).
These changes are evenly distributed among the teeth, but their intensity differs between the different groups of teeth.
Especially the aesthetically important maxillar-anterior teeth area, a discoloration attracts considerable attention. The disease leads to a personal dissatisfaction of the own appearance for many sufferers.
A great number of different therapeutic options have been utilized for the treatment of the disease so far. This includes a professional bleaching, a micro abrasion, a dental restoration and the provision of veneers and / or crowns and combinations thereof for fluorotic teeth.
Within the scope of this study, the masking effect should be examined by means of infiltration therapy, depending on the severity of fluorosis.
The utilized test products are previously certified therapeutic medical devices with clinical trials. Promising studies committed in a controlled artificial environment and a number of case reports have been published so far, showing the new therapy's positive therapeutic potential.

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Brief Summary in Scientific Language

Within the scope of this randomized, controlled, monocentric, simply blinded In-vivo clinical trial, the masking effect should be evaluated with the micro-invasive infiltration therapy according to the dependence of the dental fluorosis' severity. Furthermore, the masking effect of a bleaching treatment and the infiltration therapy should be compared. The treatment results are evaluated photo-optically with standardized photographs and subsequent digital photo analysis (ImageJ) and with a color determination meter (V Easyshade, VITA, Germany).
Dental fluorosis (ICD-10-GM-2016 K00.3) is the most common cause of intrinsic tooth discoloration and appears during the mineralization phase of unerupted teeth. The dental fluorosis' prevalence measures 7,1 % to 11,3 % [Pieper et al., 2008; Momeni et al., 2007] in Germany.
The clinical picture of dental fluorosis is characterized by white opacities, which vary from small spots and lines ("mottling") to extended areas. More distinctive cases result in brown discoloration and superficial enamel fractures ("pittling").
The primary goal of the dental fluorosis therapy should be an appearance improvement of the tooth in the aesthetic region if desired by the patient.
The infiltration technique provides a new therapeutic option of hypomineralized enamel areas with a low viscous resin (ICON®, DMG, Hamburg). The basic principle is based on the removal of the superficially stronger mineralized enamel layer by etching with 10 percent of hydrochloric acid (about 30-40 µm enamel are etched away in 2 minutes). Subsequently, the exposed lesion body will be infiltrated and sealed with a low viscous resin (infiltrant). This infiltrant has similar optical properties of healthy tooth enamel. The masking of a lesion is based on a change in the refractive index.
Therefore, the primary objective of this study is to prove that dental fluorosis can be masked successfully. Patients of legal age with fluorosis on the teeth 15-25 and 35-45 will be treated at the center for Tooth, Oral and Orthodontics, a polyclinic for tooth preservation and periodontology in Cologne, Germany.

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Organizational Data

  •   DRKS00010465
  •   2016/08/26
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  •   yes
  •   Approved
  •   16-188, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   K00.3 -  Mottled teeth
  •   K03.6 -  Deposits [accretions] on teeth
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Interventions/Observational Groups

  •   Group 1 (Placebo Bleaching therapy + Infiltration therapy)

    Masking of the dental fluorosis with ICON infiltration (DMG, Hamburg) after previous placebo bleaching therapy of the teeth 15-25 and 35-45 with Relief ACP Oral Care Gel (Discus Dental Europe; Rotterdam, Netherlands).
  •   Group 2 (Bleaching therapy + Infiltration therapy)

    Masking of the dental fluorosis with ICON infiltration (DMG, Hamburg) after previous In-Office-Bleaching of the teeth 15-25 and 35-45 with a Philips Zoom standard material! Chairside Light – Activated Whitening Gel 25 % H2O2 (Discus Dental Europe; Rotterdam, Netherlands).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

• 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).
For photo-optical analysis an index tooth is determined. The index tooth shows the most servere dental fluorosis. By using the formula ΔE = ((ΔL*)2+(Δa*)2+(Δb*)2)1/2 , the color difference can be calculated.

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Secondary Outcome

•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)
•Patient satisfaction (PZ) + OHIP 14 according to the overall aesthetic result and the treatment comfort (1 hour after completion of infiltration)
•Long-term results; Improvements after treatment during the observation period (1, 3, 6 months) (variables: ΔE and optical assessment by non-specialist judge; PZ)
•Accordance of the colorimeter VITA Easyshade V's ∆E value and the standardized, digital photographs evaluated by ImageJ

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/07
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltung und Parodontologie
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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    • Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltung und Parodontologie
    • Mr.  ZA  Christoph  Schoppmeier 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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    • Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltung und Parodontologie
    • Mr.  ZA  Christoph  Schoppmeier 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Köln Fortune - Das Forschungsförderungsprogramm
    • Dekanat (Haus 42, Forum) Erdgeschoss Zimmer 007-009 Joseph - Stelzmann - Str. 20
    • 50931  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/11/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.