Trial document




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  DRKS00009628

Trial Description

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Title

Randomized controlled clinical study on the Long-term success of implants and the prosthetic supply for rehabilkitation of single-tooth gaps in postertior tooth regions depending on the material selection for hybridabutment crowns.

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Trial Acronym

iSy-Hybridabutment

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In a randomized clinical study, the Long-term success of iSy-implants (Camlog, D) for rehablitation of single-tooth gaps in posterior tooth regions and depending on the material selection for the implant retsorations will be examined. The success and cost-efficiency of the Treatment with the screwed-in hybrid abutment crowns with different modulus elasticity, which are produced by a CAD/CAM-process, shall be evaluated.

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Brief Summary in Scientific Language

Target of the study is to investigate the long-term success of monolytic hybridbautment crowns.The implant system used, and the insertion of hybrid abutment crowns represent a cost-effective alternative to established titanium implants and implant restorations. The system is based on a reduced surgical approach and the consistent CAD / CAM integration for the prosthetic restoration. Concomitantly the surgery for the patient by avoiding a second intervention should be less invasive.
The null hypothesis is that there are no differences in long-term success of the implant- crown complex can be detected in dependence on the material used by the hybrid abutment crown. The alternative hypothesis is that orienting and exploratory a difference in the rate of loss between the two groups can be found.
It is a single-center randomized controlled clinical trial. The evaluation is performed blinded. 60 patients in which the implant prosthetic care a single tooth gap in the upper or lower jaw is necessary, take part in the study.
Primary target of the evaluation is the loss of the implant differentiated in an observation period of 5 years after insertion by the two groups of materials.
As a secondary objective variables biological and technical complications are subdivided into the two groups of materials will be examined. In addition, patient satisfaction (VAS), the Pink Aesthetic score after Fürhauser et al (2005), the abrasion of the materials and the long-term stability of the implant supplied (Periotest) and economic aspects will be comparatively evaluated.

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Organizational Data

  •   DRKS00009628
  •   2015/11/09
  •   [---]*
  •   yes
  •   Approved
  •   327/15, Ethik-Kommission der Universität Ulm
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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

  •   Totally 60 patients in which the replacement of a missing tooth (single-tooth gap) in the posterior region in the upper or lower jaw is planned by an implant-supported supply, participate in the study. In 30 patients, the supply is made with a monolithic hybrid abutment crown of lithium disilicate (e.max).
  •   In 30 patients, the supply is made with a monolithic hybrid abutment crown
    of a hybrid ceramic (enamic).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary target of the Analysis is the loss of the implant differentiated in an Observation period of 5 years after Insertion by the two Groups of different material selection for the prosthetic supply.

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Secondary Outcome

Biological and technical complications at the implant-crown complex
Clinical parameters: probing depth (PD), Ginigival Index (GI), plaque index (PI), bleeding on probing (BOP), implant stability (Periotest) and bone resorption (standardized radiographs).
echnical complications: Chipping, screw loosening or
Screws fractures.

Microbiological effects of different crown materials.

Accuracy of implant position after 3-D planning and implementation without a template.

abrasion of different crown materials at the crown and the antagonistic teeth.

Aesthetic result (Pink Aesthetic score after Fürhauser et al.2005

Patient satisfaction (VAS)

Efficiency of procedures. This aspect of the study uses the data of the randomized clinical trial of a semi-mounted cost-benefit analysis in the test and control group with the described method (Piggy-Back). The economy is faced based on the documented cost of treatment (dental, dental services and material costs) of patient satisfaction.
The parameters are collected at the following time points: baseline (1 week after onset of the crown), 6 Monte, 1, 2, 3, 4 and 5 years. Deviating from this the microbiological survey findings is done after 6 months and 2 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/11/15
  •   60
  •   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

Single tooth gap in the maxillary posterior region
Single tooth gap in the lower jaw posterior region
he extraction is back at least 3 months. It made exclusively early implantation (3 - 6 Months post-extraction) and late implantations (> 6 months post-extraction).
The space boundaries may be natural teeth or implants.
There must be a contralateral natural tooth may be present as a reference tooth, as well as an antagonistic dentition.
The patient has good oral hygiene and compliance.
Informed consent is present.

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Exclusion Criteria

Persons under 18 or legally incompetent persons
Untreated acute periodontitis
Heavy smokers (more than 10 Zig / d.)
Use of bisphosphonates
Pregnant
Alcohol or drug addicts
Patients with an infectious disease such as hepatitis or HIV or AIDS
Patients with severe diabetes m.
Immediate implantation

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Addresses

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    • Universitätsklinikum Ulm/Studienleiter: Prof. Dr. Ralph G. Luthardt, Klinik für Zahnärztliche Prothetik
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche Prothetik
    • Mr.  Dr. MSc  Sigmar  Schnutenhaus 
    • Breiter Wasmen 10
    • 78247  Hilzingen
    • Germany
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    • Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche Prothetik
    • Mr.  Dr. MSc  Sigmar  Schnutenhaus 
    • Breiter Wasmen 10
    • 78247  Hilzingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Ulm/Studienleiter: Prof. Dr. Ralph G. Luthardt, Klinik für Zahnärztliche Prothetik
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Camlog Foundation
    • Margarethenstrassew 38
    • 4053  Basel
    • Switzerland
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Status

  •   Recruiting ongoing
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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.