Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007102

Trial Description

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Title

CAD/CAM hybrid-ceramic/composite vs. ceramic minimal invasive therapeutical intervention of severe non carious lesions: Clinical performance and quality of life improvement

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Trial Acronym

MINERVA Pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Dental erosion is recognized as a global public oral health problem leading to significant esthetic and functional impairments for anterior and posterior teeth. Novel techniques based on computer aided design-manufacturing (CAD/CAM) could introduce an innovative approach for minimal invasive and yet affordable restorations, making oral health available to a wide patient population. Therefore the present study proposes to investigate the mid-term performance of patients with severe erosive lesions after therapeutical intervention with minimal invasive CAD/CAM fabricated composite restorations will be compared to manually produced minimal invasive all-ceramic restorations. The impact on patient´s quality of life and patient-centered satisfaction with the esthetic and functional treatment outcome will be addressed.

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Brief Summary in Scientific Language

Dental erosion is recognized as a global public oral health problem leading to significant esthetic and functional impairments of affected patients. Anterior and posterior teeth in the upper and lower jaw reveal extensive tooth substance loss. Restoring such teeth with conventional metal ceramic full coverage crowns frequently involves elective endodontic therapy, surgical crown lengthening procedures and major additional loss of tooth structure. Minimal invasive manually fabricated restorations were hence developed, but are, due to their high costs, not available to the majority of patients. Novel techniques based on computer aided design-manufacturing CAD CAM could introduce an innovative approach for minimal invasive and yet affordable restorations, making oral health available to a wide patient population. To date, high-level evidence on their clinical behavior for erosion treatment is lacking. Therefore the present study proposes a randomized controlled non-inferiority multicenter prospective clinical trial. The mid-term performance of patients with severe erosive lesions after therapeutical intervention with minimal invasive CADCAM fabricated composite restorations will be compared to manually produced minimal invasive all-ceramic restorations. The impact on patient´s quality of life and patient-centered satisfaction with the esthetic and functional treatment outcome will be addressed. If the novel CAD-CAM approach shows comparable results to manually produced restorations, a low-cost highly effective treatment modality might be established for a large group of severe erosion patients.

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Organizational Data

  •   DRKS00007102
  •   2015/08/26
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  •   yes
  •   Approved
  •   539/14 (MPG §23b MPG), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   K03.2 -  Erosion of teeth
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Interventions/Observational Groups

  •   Computer aided design and computer aided manufacturing (CAD/CAM) technology will be used to fabricate minimal invasive restorations from machinable composite materials. Affected anterior teeth will be restored with minimal invasive full-coverage crowns (0.8 mm thickness) and posterior teeth with defect-oriented onlay and overlay restorations.
  •   Minimal invasive traditionally fabricated all-ceramic full-coverage crowns (0.8 mm thickness) will be applied for all affected anterior teeth and all-ceramic defect-oriented onlay and overlay restorations will be used for the posterior dentition.
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Characteristics

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

Feasibility (patient’s expectation and evaluation of the treatment outcome) messured at 1 year follow-up

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Secondary Outcome

Failure time, Saftey: Rate of (Serious) Adverse Events over 1 year

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/20
  •   6
  •   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

• Patients ≥ 18 years of age
• Patients that reveal extensive erosive lesions (Basic Erosive Wear Examination/BEWE Index 14-18) due to exogenous (former excessive consumption of acidic drinks) or endogenous factors (exposure to gastric juice due to gastro oesophageal reflux disease (GERD) or eating disorders such as bulimia and anorexia nervosa)
• Patients with severe loss (> 2 mm) of the vertical dimension of occlusion
• Patients with hypersensitivity of the teeth
• Patients with reduced chewing ability
• Patients with impaired aesthetics
• Patients compliant to fill out questionnaires on food behaviour forms
• Patients that will be in need of a full-mouth rehabilitation (n=14-28 teeth per patient); Cessation of erosion progression is mandatory
• Favourable and stable occlusal relationship
• Sufficient height of abutment teeth (4.5 mm)
• Vital and non-vital abutment teeth, which are free of any radiologic diagnosable pathological changes and which are clinically acceptable, or which exhibit a lege artis endodontic treatment
• Pocket depth at the abutment teeth < 4 mm
• Tooth mobility < II
• Multi-root teeth furcation < 2
• Sufficient treated dentition or planned treatment in the course of the therapy (in this case, the costs are supported by the patient)

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Exclusion Criteria

• Patients that reveal erosive lesions due to a history of alcohol or drug (methamphetamine/ecstasy) abuse, missing teeth, poor oral hygiene (pocket depths > 3mm, Papillary Bleeding Index > 35% or pronounced parafunctions)
• Patients with allergies to any of the materials applied during the study
• Patients with diseases whose general status falls into the category IV of the American Society of Anaesthesiologists/ASA classification (patients with live-threatening severe general diseases and obvious limitation of their activity)
• Patients with psychiatric problems
• Severe bruxism, malocclusion (deep bite, non-occlusion, cross bite) or other destructive habits
• Patients without opposing dentition
• Patients with acute symptoms of a functional disorder, which requires a functional pre-treatment prior to the prosthetic therapy

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Zahnärztliche Prothetik Department für Zahn-, Mund- und Kieferheilkunde
    • Ms.  Prof. Dr.  Petra  Gierthmühlen 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Zahnärztliche Prothetik Department für Zahn-, Mund- und Kieferheilkunde
    • Ms.  Prof. Dr.  Petra  Gierthmühlen 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Albert-Ludwigs-Universität Freiburg Medizinische Fakultät
    • Elsässer Str. 2
    • 79110  Freiburg
    • Germany
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    • Ivoclar Vivadent AG
    • Bendererstrasse 2
    • 9494  Schaan
    • Liechtenstein
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    • VITA Zahnfabrik H. Rauter GmbH & Co. KG
    • Postfach 1338
    • 79704  Bad Säckingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/28
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Trial Publications, Results and other Documents

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