Trial document




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  DRKS00004158

Trial Description

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Title

Periimplantitis and soft-tissue defects of dental implants – A pilot study on the fixing of the suprastructure as a possible factor affecting aetiology

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Trial Acronym

InKo-Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is a prospective clinical study to examine, which kind of abtument may reduce the number of complications of implant supported single crowns. Possible complications are undetected excess cement in the periimplant soft tissue and loss of retention of the crown. Abutments are titanium cylinders which are screwed into the implant and simulate the prepared tooth stump. On this abutment the crown can be fixed. Today different kinds of abutments are used. This clinical study compares standard and individual abutments. The primary outcome is to examine the undetected excess cement on both abutments after 2 weeks. Secondary outcomes are the examination of the periimplant soft tissue for volumetric changes or signs of inflammation. Cases of loss of retention will also be documented. To secure a high scientific informatic value the abutment will be randomized, what means that the choice which abutment is used will be at random.

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Brief Summary in Scientific Language

Inflammatory destruction of the periimplant bone (periimplantitis) is the most common reason for late implant loss. For implants supporting cemented suprastructures, a possible reason is the presence of undetected excess cement in the periimplant soft tissue, especially when standard abutments are used, when the cement gap is subgingival. Individual abutments might not face this problem, because the cement cap can be constructed so it is cleanable, but no data are yet available. This pilot study will be conducted on 20 patients, comparing standard and individual abutments. The primary endpoint of the pilot study is to quantify undetected excess cement on standard and individual abutments with implant-supported single crowns after two weeks. In addition, the periimplant soft tissue will be examined for volumetric changes or signs of inflammation, and cases of loss of retention will also be documented. All working steps in fabrication of the implant-supported single crowns will be performed by one dentist and one dental technician only. A randomization will be performed and all investigations in the study will be performed by two calibrated investigators who did not participate in the dental treatment at any time. The Institute of Medical Biometry and Informatics (IMBI) of the University of Heidelberg will be involved in the study.
The aetiology of periimplantitis is numerous and mostly unknown, and the incidence is increasing drastically. This pilot study will enable precise calculation of sample size for a main study. The purpose of the main study will be to formulate precise recommendations for treatment which enable undetected excess cement in the peri-implant soft tissue, a possible aetiological factor of periimplantitis, to be avoided.

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Organizational Data

  •   DRKS00004158
  •   2012/07/27
  •   [---]*
  •   yes
  •   Approved
  •   S-268/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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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
  •   Retention of implant-supported single crowns
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Interventions/Observational Groups

  •   standard abutment
  •   individual abutment
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is to examine the undetected excess cement on standard and individual abutments after 2 weeks (explorative examination).

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Secondary Outcome

Secondary outcomes are the examination of the periimplant soft tissue for volumetric changes or signs of inflammation, and cases of loss of retention will also be documented.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/11/11
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria consist of signing the informed consent, being in the age of 18-100 and legally competent. Only patients with a bonelevel-implant, that is osseointegrated and has no clinical signs of inflammation will be included. Patient must be informed in detail about the treatment procedure, the randomization and the costs.

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Exclusion Criteria

Exclusion criteria are: vulnerable patients, pregnancy or brestfed, patients with tissue level implants or bonelevel implants that have clinical signs of mucositis or periimplantitis, missing informed consent, refusing the randomization and patients with bisphosphonates or radiation therapy in the head or neck area.

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Addresses

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    • Universitätsklinikum Heidelberg Mund-Zahn-Kieferklinik, MZK II Poliklinik für Zahnärztliche Prothetik
    • Ms.  Dr. med. dent.  Stefanie  Kappel 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Mund-Zahn-Kieferklinik, MZK II Poliklinik für Zahnärztliche Prothetik
    • Ms.  Dr. med. dent.  Stefanie  Kappel 
    • INF 400
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Mund-Zahn-Kieferklinik, MZK II Poliklinik für Zahnärztliche Prothetik
    • Ms.  Dr. med. dent.  Stefanie  Kappel 
    • INF 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft e.V. (DFG)
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Universitätsklinikum HeidelbergPoliklinik für Zahnärztliche Prothetik
    • Mr.  Prof. Dr.  Peter  Rammelsberg 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/31
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Trial Publications, Results and other Documents

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