Trial document




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  DRKS00009496

Trial Description

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Title

Effectiveness of ridge preservation for early implant placement compared to spontaneous healing

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

After the extraction of a tooth some of the surrounding bone will be lost and leads to a reduction of the ridge.
The aim of the so-called ridge prevention is to counteract this loss. Therefore, the socket is filled with a substitute material. Additionally, the wound can be closed with a thin membrane ("skin").
Depending on the clinical situation, the best time point for implantation will be chosen. Implants are often placed 8 weeks after tooth extraction, a so called „early implantation. At this time-point, the soft tissues are healed and a proper wound closure can be obtained.
For these relatively short period it is not known yet if the ridge preservation leads to a beeter result or whether spontaneous healing of the wound is already sufficient.
The aim of the study is therefore to find out whether a ridge prevention leads to better results compared to spontaneous healing in situation with early implant placement.

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Brief Summary in Scientific Language

After tooth extraction a variety of soft and hard tissue alterations are initiated and lead to a reduced alveolar ridge contour. Clinically, a mean resorption of the buccal bone contour of approximately 50% taking place mainly within the first 3 months after tooth extraction was observed. The possible consequences of these resorption processes may significantly hamper implant placement without additional bone regeneration techniques and may yield an inadequate esthetic outcome due to the ridge deficiencies.
The aim of the present study is to evaluate the radiographic, clinical and histologic changes of different techniques for ridge preservation compared to spontaneous healing within the first 6 (radiographic) to 8 (clinical and histologic) weeks after tooth extraction.
Furthermore the longterm stability of the soft and hard tissues will be evaluated. Therefore the patients will participate in a longterm follow up, up to 5 years after insertion of the crown. This amendment has been approved by the Ethical Committee of Zurich (28.11.2016).

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Organizational Data

  •   DRKS00009496
  •   2015/10/08
  •   [---]*
  •   yes
  •   Approved
  •   2015-0420 (PB_2016-02507), Kantonale Ethikkommission 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

  •   Ridge preservation with Bio-Oss® Collagen at the bone level and application of a collagen matrix
  •   Ridge preservation with Bio-Oss® Collagen at the bone level without application of a collagen matrix
  •   Spontaneous healing without ridge preservation
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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), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Loss of volume between pre-extraction and 8 weeks based on volumetric measurements (by superimposition of the scanned models).

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Secondary Outcome

• clinical condition of soft tissues at 8 weeks
• The height of the oral and buccal aspect of the alveole will be measured clinically (at Visit 5).
• Thickness of the buccal bone crest, bony horizontal ridge width and dimensional changes are evaluated by CBCT scans (Between extraction and 6 weeks).
• A histologic assessment at the implant site will be performed at implant placement (at Visit 5).
• Ridge width will be analysed (at Visit 5).
• Volumetric changes of soft
and hard tissues, peri-implant health as well as implant survival up to five years after crown insertion

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/12
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Informed Consent as documented by signature
• Requiring extraction of at least one upper or lower asymptomatic front tooth or premolar
• Bleeding on probing ≤ 20%
• Plaque index ≤ 20%
• Systemically healthy

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Exclusion Criteria

• Women who are pregnant or breast feeding at the date of inclusion
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Smoking more than 20 cigarettes/day

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Addresses

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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  PD Dr. med. dent.  Daniel  Thoma 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  PD Dr. med. dent.  Daniel  Thoma 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  PD Dr. med. dent.  Daniel  Thoma 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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Sources of Monetary or Material Support

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    • Geistlich Pharma AG
    • 6110  Wolhusen
    • Switzerland
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • 8032  Zürich
    • 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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