Trial document




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  DRKS00008591

Trial Description

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Title

Randomized controlled clinical trial evaluating the soft tissue attachment and morphology under different microbiological conditions comparing Zirconia and Titanium dental implants.

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Trial Acronym

ZrO2 vs Ti

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URL of the Trial

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Brief Summary in Lay Language

For this study, we are looking for patients with a tooth gap, that is to be closed by two implants. Today, most implants are made of Titanium (metal). After implantation, these implants grow together with the surrounding bone and are thus firmly integrated in the jaw.
However, implants made of metal may lead to a visible gray discoloration of the overlying mucosa. Furthermore, many patient prefer metal-free solutions. Therefore white implants made of zirconia (ceramic) have been developed. With respect to stability in the bone there are no differences between these two types of implants. However, it is no yet known, if there are any differences referring to the surrounding soft tissue (gums).
The first objective of the study is to find out whether there are differences in the amount and quality of the soft tissue around these two implant types.
The second objective is to examine the influence of a temporary reduction of oral hygiene on the health of the soft tissue around both implant types.


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Brief Summary in Scientific Language

Dental implants have become a predictable treatment
modality for the replacement of single or multiple missing teeth. Titanium and titanium alloys are considered as gold standard and the materials of choice due to favorable physico-chemical properties and their biological attributes (osseointegration).
Some limitations apply, since it has been shown that during clinical function soft tissue shrinkage, recessions, and periimplant lesions can leave the implant head visible. In such cases and in situations with an inadequate width and/or thickness of the peri-implant mucosa, the grayish color of titanium may offer clinical disadvantages when it comes to
esthetics. Furthermore, there is an increasing demand for metal-free restorations from the patient's side. In order to overcome these issues with metal alloys and to meet current demands, ceramic materials have been introduced in dentistry.
Nevertheless, only limited information is available in the literature with respect to soft and hard tissue alterations of loaded zirconia dental implants in comparison to titanium dental implants in a clinical environment.

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Organizational Data

  •   DRKS00008591
  •   2015/06/18
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  •   yes
  •   Approved
  •   KEK-ZH-Nr. 2015-0215 (PB_2016-01767), Kantonale Ethikkommission Zürich Stampfenbachstrasse 121 CH-8090 Zürich
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Secondary IDs

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Health Condition or Problem studied

  •   K08.1 -  Loss of teeth due to accident, extraction or local periodontal disease
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Interventions/Observational Groups

  •   - Mesial implant position: placement of the titanium implant
    - Distal implant position: placement of the zirconia implant
    - additionally: 12 weeks after implant placement: experimental mucositis for 3 weeks
  •   - Mesial implant position: placement of the titanium implant
    - Distal implant position: placement of the zirconia implant
  •   - Mesial implant position: placement of the zirconia implant
    - Distal implant position: placement of the titanium implant
    - additionally: 12 weeks after implant placement: experimental mucositis for 3 weeks
  •   - Mesial implant position: placement of the zirconia implant
    - Distal implant position: placement of the titanium implant
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint (at visit 4: 15 weeks after implant placement) is to histologically
evaluate the height of the biologic width (including sulcus depth, junctional epithelium, connective tissue) around Zirconia and titanium implants.

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Secondary Outcome

The following secondary endpoints will be assessed after 1, 3 and 5 years after insertion of the final reconstruction:
• Implant survival
• Radiographic bone level
• Esthetic analysis
• Technical complications
• Biological complications
• Clinical measurements: plaque index, bleeding on probing, probing pocket depth, width of keratinized tissue

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/14
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
• At least one tooth present adjacent to the edentulous space
• At least 10 mm of vertical bone height in the mandible
• At least 6 mm of vertical bone height in the maxilla

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Exclusion Criteria

• Smoking of more than 15 cigarettes a day
• Poor oral hygiene after hygienic phase (Plaque Index over 30 %)
• Active periodontal disease
• Women who are pregnant or breast feeding at the date of inclusion

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Addresses

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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  Prof.  Ronald  Jung 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  Prof.  Ronald  Jung 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  Prof.  Ronald  Jung 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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Sources of Monetary or Material Support

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    • ITI International Team for Implantology
    • Peter Merian-Strasse 88
    • 4052  Basel
    • Switzerland
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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.