Trial document





This trial has been registered retrospectively.
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  DRKS00005978

Trial Description

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Title

Survival of 3D-planned and template-based implants inserted depending on the pre-implant hard and soft tissue management - a randomized controlled clinical trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to investigate the benefits of 3D design and template-assisted implant placement in conjunction with measures of socket preservation (hard and soft tissue management) for preserving the bone. It is expected to be reduced by the 3D planning in the context of template-assisted implant placement in a group of patients with / without socket preservation, the necessary measures augmentation during implant insertion. Concomitantly, the surgical procedure for the patient should be less invasive. It is believed that the cost of the socket preservation is lower than the cost of additional required augmentation. In addition, it is expected that in combination with a navigated surgical procedures, the benefits of the hard and Weichgewebsmanagementes can be optimally utilized

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Brief Summary in Scientific Language



The null hypothesis is that there are no differences in the Survival of 3D-planned and template-based implants inserted depending on the pre-implant hard and soft tissue are demonstrated. The alternative hypothesis is that orienting and exploratory a difference in the loss rate between the two groups can be found.
It is a single-center randomized controlled clinical trial. The evaluation is performed in a blinded. 60 patients where the removal of a tooth in the upper jaw is necessary and where a supply of the implant prosthetic tooth is planned to be removed after taking part in the study. From an upstream clinical trial is a clearly defined, well-documented and highly motivated group of patients available to be built on for the scheduled trial. The upstream study ends with the digital volume tomogram to determine the existing 11 weeks after tooth extraction bone. The study sought starts with the digital volume tomogram and the 3D planning of the implant position.
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 with / without pre-implant hard and soft tissue management. In addition to target size, the accuracy of 3D implant position compared to 3D planning.
Other side targets biological and technical complications are subdivided into the two groups with / without pre-implant hard and soft tissue studied. In addition, patient satisfaction (VAS), the Pink Aesthetic score after Fürhauser et al are. 2005, the primary stability of the implant (Osstell ISQ) and the subsequent stability of the implant-served (periotest) and the efficiency of the method comparatively evaluated.










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Organizational Data

  •   DRKS00005978
  •   2014/07/08
  •   [---]*
  •   yes
  •   Approved
  •   41/14, 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

  •   It is a single-center randomized controlled clinical trial. The evaluation is performed in a blinded. 60 patients where the removal of a tooth in the upper jaw is necessary and where a supply of the implant prosthetic tooth is planned are taking part in the study. From an upstream clinical trial is a clearly defined, well-documented and highly motivated group of patients available to be built on for the scheduled trial. The upstream study ends with the digital volume tomogram to determine the existing 11 weeks after tooth extraction bone. The study sought starts with the digital volume tomogram and the 3D planning of the implant position.
    Test group: 30 patients. 3D planning and template-guided implant placement after tooth extraction where socket preservation (sombrero) was performed.
  •   Randomization is done in test group with socket preservation and control group without socket preservation.
    Control group: 30 patients. 3D planning and template-guided implant placement were performed in which before no further action for Socket Preservation after tooth extraction were performed.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Control group receives no treatment
  •   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 with / without pre-implant hard and soft tissue management. In addition to target size, the accuracy of 3D implant position compared to 3D planning.

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Secondary Outcome

Other side targets biological and technical complications are subdivided into the two groups with / without pre-implant hard and soft tissue studied. In addition, patient satisfaction (VAS), the Pink Aesthetic score after Fürhauser et al are. 2005, the primary stability of the implant (Osstell ISQ) and the subsequent stability of the implant-served (periotest) and the efficiency of the method comparatively evaluated.
Acquisition of data: baseline at the completion of prosthetic services, 1/2 year later, 1, 2, 3 and 5 years later

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/05/06
  •   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

Patients where the removal of a tooth in the upper jaw is necessary and where a supply of a implant is planned.
All patients come from the study before.

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Exclusion Criteria

• Persons under 18 or not legally competent persons
• Detectable primary additional for augmentation need
• insertion of the implant with a Drilling template not possible (no sufficient mouth opening).
• Heavy smokers (more than 10 cig. / Day)
• 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.

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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 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.