Trial document




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  DRKS00000226

Trial Description

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Title

Evaluation of a one-piece ceramic implant used for single tooth replacement and three-unit bridge restoration. A cohort 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 the present investigation is to clinically apply a one-piece zirconia implant system with a defined structured surface and to evaluate it over a period of 5 years. Thirty patients will participate in this clinical investigation (additional 30 patients will be enrolled at the University of Zurich receiving the sqame type of implants).
At the beginning of the investigation for all patients the medical and dental history will be collected. Subsequently, a dental inspection is perforemd where the teeth, the gums as well as the temporomandibular joints are evaluated. Furthermore, radiographs of the teeth and jaws are perforemd. To reduce the possibility of infections after the surgical intervention all patients will receive an antibiotic coverage. The surgical intervention for oral ceramic implants resembles the one for convetional oral implants. The area of the jaw in which implants will be placed will be anesthetized with local anesthesia. After anesthesia is obtained the soft tissues in the area where the implants will be placed is reflected from the underlying bone. The position of the implants will be marked in the alveolar bone using a round bur. With spiral drills with increasing widths the implant bed is created under coolung using sterile saline. Subsequently, the implants are placed applying the respective tools. The soft tissue will then be sutured around the implant abutment (so-called one-stage procedure). After a healing period for the implants of 16 weeks in the upper jaw and 8 weeks in the lower an impression is taken using dental impression materials. If necessary the heads of the implant heads will be prepared using diamonds. Retractions cords are placed in order to open a space between the implants and the soft tissue and the impressions are taken. Afterwards, the implant borne restorations are fabricated in the dental laboratory. After try-in and finalizing of the restorations, they will be cemented onto the implants using dental cement. The implants as well as the periimplant soft tissues will be evaluated after insertion of the restorations , after 6, 12, 24, 36, 48 and 60 months using conventional methods (mobility testing, probing depth measurements, plaque accumulation observation, recession control). a radiographic evaluation will be carried out after implant insertion, cemtentation of the restorations, and then after12, 36 and 60 months. These are normally the intervals when radiographic controls are carried out in oral implantology.

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Brief Summary in Scientific Language

This will be a prospective, multicenter, uncontrolled cohort clinical trial in which
subjects will be consecutively included according to the inclusion and exclusion
criteria. One-piece ceramic implants and the respective fixed partial denture will
be tested. A total of 60 subjects will be treated by two clinics (Department of
Prosthodontics, University Medical Center Freiburg, Germany & Klinik für Kronen- und
Brückenprothetik, Teilprothetik und Zahnärztliche Materialkunde, Universität
Zürich; Switzerland). For the placement of the zirconia implants a 1-stage surgery and immediate temporization will be applied. Implants placed in the maxilla will be definitively restored four months after implant surgery and implants placed in the mandible two months post-surgery. The subjects will be followed for five years after receiving their prosthetic restorations and possible drop-outs and withdrawals, as well as possible adverse events, will be carefully monitored during the entire investigation period. Follow-up visits should be scheduled at 6, 12 months, 2, 3, 4, and 5 years following placement of fixed partial prosthesis or single tooth restorations. The data evaluation of the investigation will be performed after 1, 3 and 5 years after placement of the final prosthetic restoration.

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Organizational Data

  •   DRKS00000226
  •   2009/10/01
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  •   no
  •   Approved
  •   241/08, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   U1111-1111-0518 
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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

  •   Insertion of oral ceramic implants in areas of a single missing tooth or with partial edentulism with the need of a 3-unit prosthodontic reconstruction on two implants
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
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Primary Outcome

The primary objective is to evaluate the mean marginal bone resorption after 1, 3, and 5 years. The mean marginal bone resorption will be evaluated by central blind review of standardized digital/analogue periapical radiographs. The distance from the implant shoulder to the first radiographic observable bone-to-implant
contact at implant insertion (mean of mesial and distal measurements) will be subtracted from the distance from the implant shoulder to the first radiographic observable bone-to-implant contact after 1, 3, and 5 years, respectively.

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Secondary Outcome

The secondary objectives are
1. the evaluation of the safety, success, and failure of the implantation and implant
over 5 years;
2. safety of the implantation and implant by means of the assessment of adverse
events and serious adverse events within five years after implantation.

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/10/01
  •   60
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

1. Ability to understand the nature of the study and the study related procedures.
2. Written informed consent obtained according to international guidelines and local law.
3. The subjects must be in the age of 18 to 70 years old.
4. The subject must be systemically healthy and have good compliance.
5. The subject must be in need of an implant supported partial denture or implant supported single tooth restorations.
6. The subjects must have sufficient bone volume and density i.e. an osseous architecture in the implant placement region enough to receive implants of 4.0 mm in diameter and a sufficient amount of bone for placing implants with a length of at least 8 mm.
7. The osseous architecture must be such that it is possible to obtain primary implant stability, i.e. final tightening torque of 35-45 Ncm.
8. The subject must have a stable occlusal relationship with no pronounced bruxism.
9. The implant sites must be free from infection and/or extraction remnants

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Exclusion Criteria

1. Alcohol or drug abuse as noted in patient records or in patient history.
2. Smoking
3. Health conditions, which do not permit the surgical procedure (see section D5).
4. Reason to believe that the treatment might have a negative effect on the subject?s total situation (psychiatric problems), as noted in patient records or in patient history.
5. The patient has infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoetic system, hematological disorders, wound healing disturbances, disorders of the endocrine system (i.e., uncontrolled diabetes), local (i.e., tumors, ulcers etc) or other contraindications for dental surgery as noted in patient records or in patient history. A female participant is pregnant.
6. The subject is not able to give her/his informed consent to participate.
7. The need of bone augmentation (e.g. sinus augmentation procedure) before implant installation to obtain a prosthetically correct implantation transversally. However, a minor augmentation procedure to cover exposed threads or interproximal/buccal grafting due to deficient sites is not an exclusion criteria.
8. Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
9. Severe bruxism or other destructive habits.
10. Immediate insertion (e.g. placement of the implant immediately after extraction)
11. Intake of medication that is known to interfere with the objectives of the study and/or are contraindications of the surgical procedure within 2 weeks prior to entry into the study.
12. Intake of investigational drugs less than 30 days prior to entry into the study
13. Female patients who are pregnant or breast feeding, or female adults of reproductive potential not employing an effective method of birth control (postmenopausal state at least since 2 years, surgically sterile, hysterectomy, or effective contraceptive method until placement of the final prosthetic restoration [condoms for women, diaphragm or contraceptive sponges, intrauterine device, hormonal contraception]).
In female adults of reproductive potential, implantation will only be performed if a negative urine pregnancy test result dated 3 to 14 days prior to implantation is documented. Women have to be advised that they must not become pregnant until placement of the final prosthetic restoration.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • VITA Zahnfabrik H. Rauter GmbH & Co. KG
    • Mr.  Dr. med.  Jens  Fischer 
    • Ballyweg 6
    • 79713  Bad Säckingen
    • Germany
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    • Universitätsklinikum Freiburg Zahn-, Mund-, und Kieferheilkunde - Abteilung für Zahnärztliche Prothetik
    • Mr.  Prof. Dr.  Ralf Joachim  Kohal 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Zahn-, Mund-, und Kieferheilkunde - Abteilung für Zahnärztliche Prothetik
    • Ms.  Angelika  Pawik Stöhr 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • VITA Zahnfabrik H. Rauter GmbH & Co. KG
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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