Trial document




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  DRKS00005611

Trial Description

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Title

Randomized prospective study for the evaluation of the clinical long-term behavior of all-ceramic partial crowns and onlays made of VITA Suprinity®

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Trial Acronym

Suprinity®

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URL of the Trial

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Brief Summary in Lay Language

Background: If large parts of the natural tooth structure are lost, e.g. due to caries, these teeth must be restored with indirect restorations like partial or even full crowns in order to achieve a long-term preservation, stabilization, and support of the remaining tooth structure. For a restoration with partial crowns, various materials are available. Conventional partial crowns are made of metal alloys (high noble alloys such as gold, or non-precious alloys). This type of partial crowns has led to reliable results in daily routine. However, due to the missing ceramic veneering, the restorations were not tooth-colored and thus esthetically not satisfactory. Over the last years, all-ceramic partial crown restorations have gained importance in the dental practice. These all-ceramic (metal-free) partial crown restorations allow a nearly natural appearance of the dental reconstruction.

All-ceramic partial crowns are generally luted adhesively, i.e. bonded (“total etch technique”). Various procedures are available: self-adhesive cements or special luting techniques with self-/light-curing cements. Up to now, referring to the long-term stability of ceramic partial crowns, no sufficient scientific data indicating the superiority of one of these techniques are available. Therefore, both methods are compared in this clinical study.

Aim of the study: This prospective clinical study aims at the evaluation of the clinical long-term success of all-ceramic partial crowns (ceramics: “VITA Suprinity”, VITA Zahnfabrik, Bad Säckingen, Germany). Different cementation procedures are compared: self-adhesive cement vs. total-etch technique with dual-curing composite cement over an observational period of 5 years (10 years if applicable).

Hypothesis: Partial crowns/onlays made of VITA Suprinity® and cemented with a self-adhesive cement show comparable survival and success rates as VITA Suprinity® partial crowns/onlays which were fixed with the total-etch technique in combination with a dual-curing composite cement.

Dental treatment: Patients with teeth which met the indication criteria for an all-ceramic partial crown were included in the study. The findings had to be diagnosed during regular dental treatment. In case of a clinical necessity for a restoration with one or maximum two partial crowns, the decision for one of the cementation procedures was made by lot after the patient had given written consent to participate in the study.

Dental (follow-up) examinations: In regular intervals, the partial crowns are re-evaluated with regard to their long-term stability. This procedure is independent from the individual maintenance and control appointments in the dental office. Annual follow-up examinations of the partial crowns (after 1, 2, 3, and 5 years) will be performed by the Department of Preventive Dentistry, Periodontology and Cariology of the University Medical Center Göttingen (Göttingen, Germany) (Study leader: PD Dr. Ziebolz). In the dental examinations, data such as caries findings, sensitivity to cold, BoP (bleeding on probing) will be collected as well as information on the situation of the periodontium (periodontal status: measurement of pocket depth, degree of tooth loosening).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005611
  •   2014/01/09
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  •   no
  •   Approved
  •   27/7/13, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   partial dental hart tissue losing
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Interventions/Observational Groups

  •   All-ceramic partial crown/inlay, cemented with the total-etch technique and a dual-curing composite system (Syntac classic und Variolink II (IvoclarVivadent, Schaan, Lichtenstein)
  •   All-ceramic partial crown/inlay cemented with self-adhesive cement (RelyX Unicem, 3M Espe, Seefeld, Germany)
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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
  •   N/A
  •   N/A
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Primary Outcome

Survival rate: Long-term success defined as survival of all-ceramic partial crowns/onlayss made of VITA Suprinity® ceramics after 1,2 3, 5 years, based on the criteria of Pjetursson et al. (2007).

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Secondary Outcome

Success rate: Acquisition of technical and biological complications (success) after 1,2 3, 5 years, based on the criteria of Pjetursson et al. (2007).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/01/13
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Men or women age 18+
• written consent for the participation/capacity to consent
• Posterior single crowns (premolars, molars) with natural antagonistic teeth
• vital and symptom-free abutment teeth with unobtrusive initial x-ray findings*
• periodontally rehabilitated (sufficient) partially edentulous arch or no periodontal treatment required

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Exclusion Criteria

missing antagonistic teeth
• antagonists on implants
• endodontic treatment
• bruxism
• patients younger than 18 years
• abutment teeth with pain symptoms
• implants as abutments
• dental treatment and/or examination cannot be performed due to poor general state of health
• existing systemic disease: diabetes mellitus, kidney insufficiency
• immunosuppressed patients: organ transplants, autoimmune disorders (rheumatic arthritis, chronic gastro-intestinal disease)
• infektious patients (hepatitis A, B, C, TBC, HIV; on inquiry)
• addicts (alcohol addiction)
• patients with seizure or nervous disorders
• existing pregnancy (on inquiry)
• allergies to ingredients of the cements (A as well as B)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • VITA Zahnfabrik H. Rauter GmbH & Co. KG
    • Mr.  Dr.  Benjamin  Just 
    • Ballyweg 6
    • 79713  Bad Säckingen
    • Germany
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    • Universitätsmedizin GöttingenPoliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie
    • Mr.  PD Dr.  Dirk  Ziebolz 
    • Robert.-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin GöttingenPoliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie
    • Mr.  PD Dr.  Dirk  Ziebolz 
    • Robert.-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • VITA Zahnfabrik H. Rauter GmbH & Co. KG
    • Mr.  Dr.  Benjamin  Just 
    • Ballyweg 6
    • 79713  Bad Säckingen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.