Trial document




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  DRKS00006163

Trial Description

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Title

Influence of adhesive abutments on periimplant tissues

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

With the increasing demand of highly aesthetic implant restorations during last years, the more important became zirconia abutments. Functionally titanium abutments could be regarded as gold standart, but there are certain disadvantages when it comes to aesthetic considerations. The implant supported crowns will be less translucent, since the metall core is less tanslucent compared to a zirconia abutment, moreover it has to be covered by opaque ceramics. With respect to the emergence profile, a titanium abutment might lead to a greyish coloured soft tissue margin, since the abutment might shine through a thin buccal gingiva, thus jeopardising the whole aesthetic appearance of the crown.
The pure zirconnia abutments might be more prone to fracture. In order to overcome the dilemma, the technique of glueing a zirconia core to a titanium adhesive abutment has been invented and implemented in restorative therapy of implants. The resulting gap filled by the composite glue with its residual monomer has always been part of discussion among dental professionals. It is claimed that the residual monomer located in the depth of the connective tissue attachment provoques a inflammatory cell infiltrate (ICT) which in turn is leading to a more pronounced peri-implant bone loss and subsequently might even facilitate peri-implantitis. Interleukin-1 beta (IL-1 beta) and Tumor necrosis factor- alpha (TNF-alpha) are cytocines released mainly by macrophages, mediating the non specific host response. Elastase is an important enzyme of the non specific immune response as well, produced by neutrophils. Thus, levels of IL-1 beta and TNF alpha as well as Elastase are elevated in inflammed tissue.

Therefore it is the aim of this trial to investigate whether the composite glue of adhesive abutments has an influence on the peri-implant health status.

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Brief Summary in Scientific Language

This study is conducted as a prospective, randomized, blinded, split mouth, clinical trial. Subsequent to implantatation, the studyimplants will be connected in a randomized manner (allocation to the study group will be delivered in a sealed envelope) to ether the test abutment (adhesive titanium abutments) or control abutment (monolithic titanium abutment). At the time of prosthodontic restoration a patients unique dil holder will be fabricated a used throughout the study for standardized radiographs. Furthermore samples of the crevicular fluid will be collected and shipped to the Department of periodontology of the University Giessen for quantitative analysis of pro inflammatory cytocines (IL-1, TNF-alpha, Elastase) via DNA probes. Clinical parameters such as probing pocket depth and bleeding on probing will evaluated as well. These analysis will be performed at:
1. prosthodontic restoration
2. 1/2 year after prosthodontic restoration
3. 1 year after prosthodontic restoration
4. 2 years after prosthodontic restoration
5. 3 years after prosthodontic restoration
6. 4 years after prosthodontic restoration
7. 5 years after prosthodontic restoration

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006163
  •   2014/05/21
  •   [---]*
  •   yes
  •   Approved
  •   013/1630, Freiburger Ethik-Kommission International
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Secondary IDs

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Health Condition or Problem studied

  •   K05.3 -  Chronic periodontitis
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Interventions/Observational Groups

  •   adhesive titanium abutment
  •   monolythic titanium abutment
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Active control
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

periimplant bone loss will be meassured radiographicaly with individualized film holders. The radiographs will be taken at 6 months, 1 year and thereafter on a yearly basis until 5 years after abutment connection.

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Secondary Outcome

Parameters of Inflammation of the periimplant tissues:

Therefore quantitative differences of the pro-inflammatory zytocines (IL-1 TNF-Alpha, elastase) in the creficular fluid will be evaluated. Samples of the creficular fluid will be gathered with small paper Points and zytocines will be detected with DNA probes.

Again samples will be gatherd and evaluated after 6 months, 1 year, 2 years, 3 years, 4 years, 5 years after abutment Connection.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/05/01
  •   15
  •   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

- Non smokers
- 2 implants, which have to be restored at the same time
- ASA score 1
- > 18 years of age

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Exclusion Criteria

- smokers
- ASA score >1
- simultaneous agmentation procedure during implant surgery
- pragnancy
- nursing
- < 18 years of age

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Praxis Dr. Markus Schlee & Kollegen
    • Mr.  Dr  Markus  Schlee 
    • Bayreutherstrasse 39
    • 91301  Forchheim
    • Germany
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    • Praxis Dr. Markus Schlee und Kollegen
    • Mr.  Dr  Florian  Rathe 
    • Bayreutherstrasse 39
    • 91301  Forchheim
    • Germany
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    • Praxis Dr. Markus Schlee & Kollegen
    • Mr.  Dr  Florian  Rathe 
    • Bayreutherstrasse 39
    • 91301  Forchheim
    • Germany
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Sources of Monetary or Material Support

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    • Head of clinical research, Camlog foundation
    • Ms.  BSc, MPH  Francoise  Peters 
    • Margarethenstrasse 38
    • 4053  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.