PEERS Multicenter Osseospeed TM TX Profile Implant: German Astra Soft Tissue (GAST) Maintenance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Johannes Gutenberg University Mainz
Sponsor:
Collaborator:
Dentsply Implants
Information provided by (Responsible Party):
Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01400321
First received: June 7, 2011
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

The open, prospective, non-controlled observational study is designed to provide information on the short-, medium- and long-term clinical performance of the Astra Tech OsseospeedTM implant surface in combination with a special implant design. The study will provide information on implant survival and soft tissue and bone maintenance as clinical performance of the OsseoSpeedTM TX Profile Implant in the aesthetic zone or the posterior mandible with socket like atrophy.


Condition
Inclined Atrophy of the Distal Mandible
Socket Like Atrophy of the Aesthetic Zone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PEERS Multicenter OsseoSpeedTM TX Profile Implant: German Astra Soft Tissue (GAST) Maintenance Study An Open, Prospective Observational Study to Evaluate Implant Stability, Marginal Bone and Soft Tissue Maintenance of the Astra Tech Dental Implant System: OsseoSpeedTM TX Profile Implant in Patients With Tooth Loss in the Aesthetic Zone or the Posterior Atrophied Mandible

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Implant survival [ Time Frame: after 24 months ] [ Designated as safety issue: Yes ]
    How many implants are in situ after an observational period of 24 months (2 years). Data presentation will be a Kaplan Meier Estimate.


Secondary Outcome Measures:
  • Marginal bone adaption [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
    Marginal bone adaptation will be assessed clinically as probing depth on the lingual aspect of insertion. In addition marginal bone adaption will be followed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant on intraoral radiographs with paralleling technique. Periapical radiographs will be taken pre- and postoperatively at 24 months follow-up visit. A change in marginal bone will be recorded as positive or negative shift compared to the baseline (preoperatively measured bone height).

  • Pinc aesthetic parameter [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
    Pinc aesthetic score evaluation as previously described by Fürhauser and measurement of width of keratinized mucosa and clinical crone length. Data evaluation will be a negative or positive shift compared to the preoperatively evaluated data.

  • periodontal parameter [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
    Clinical evaluation of of probing depth in mm (mesial, distal, oral and vestibular), bleeding on probing and Plaque Index as described by Sillness and Löe. Data evaluation will be a negative or positive shift compared to the preoperatively evaluated data.

  • Detection and description of implant related complications and other adverse and serious adverse events [ Time Frame: over the study period (24 months) ] [ Designated as safety issue: Yes ]

    Complications are characterized by any failure (mechanical or other) of the implant and/or the prosthetic restoration, as well as the treatment of such failures and will be recorded. The following complications must be reported to the Principal Investigator within 4 working days:

    • Failed osseointegration
    • Lost osseointegration
    • Fixture fracture Adverse events and serious adverse events detection and reporting following GCP-ICH


Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Distal region
Patients with loss of tooth in the premolar and molar region of the atrophied mandible
aesthetic zone
Patients with loss of tooth within the aesthetic zone (canine to canine)

Detailed Description:

Within the new OsseoSpeedTM TX Profile Implant from Astra Tech a special surface modification treated with diluted hydrofluoric acid is combined with an inclined implant-abutment interface to support soft tissue and marginal bone maintenance in the aesthetic zone or the socket like atrophy in the mandible. Pre-clinical studies of the OsseospeedTM modification support improvement in osseointegration. Both aspects are of special clinical interest in critical situations e.g. reduced bone quantity and quality or in case of socket atrophy with loss of the papillae. The outcome variables of interest are implant survival and the marginal bone and soft tissue response for clinical evaluation of the OsseoSpeedTM TX Profile Implant from Astra Tech. In contrast to the original treatment protocol with a healing period of 3 and 6 months for maxilla and mandible, respectively, the healing period is reduced to 3 months following the recent literature with equal clinical results. Within the present study implants will heal in a transgingival mode and loaded after a healing period of 3 months. For special indications in the aesthetic zone the implants may optionally be loaded following an early loading protocol, which comprehend temporary loading within 48h after implant insertion. Overall implant survival rates are high. However, for implants placed immediately after tooth extraction in the esthetic zone or in the socket like atrophied mandible survival rates are lower. The special physiology of bone resorption in the aesthetic zone exhibit high requirements for soft tissue and bone maintenance for good clinical long term results. Differences in pattern of marginal bone response have been described for different implant systems. The extend of bone loss as also the pattern of remodeling as reaction to OsseospeedTM surface and the special shape of the OsseoSpeedTM TX Profile Implant will be investigated within the present study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with tooth loss in the aesthetic zone or in the distal mandible with socket like atrophy. The antagonists should be natural teeth or a fixed prosthesis.

Criteria

Inclusion Criteria:

  • loss of tooth aesthetic zone (a maximum of 4 implants)
  • loss of tooth at the distal mandible (distal canine) (a maximum of 4 implants)
  • presence of inclined alveolar ridge profile
  • antagonists are natural teeth or fixed prosthesis

Exclusion Criteria:

  • < 18 years
  • Tumour or irradiation
  • bisphosphonate or cortisone intake
  • Diabetes mellitus
  • Mental illness or disorder with affection of compliance
  • Consumption of > 20 cigarettes/day
  • Bruxism
  • Acute Mucosal infection or illness (e.g. acute Parodontitis, Pemphigus, Lichen)
  • Relation of Crown to Implant ratio of > 1
  • No clinical primary stability of the implant after insertion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400321

Contacts
Contact: Wilfried Wagner, MD, DMD, PHD 00496131177334 wilfried.wagner@unimedizin-mainz.de
Contact: Maximilian Moergel, MD, DMD 00496131175459 maximilian.moergel@unimedizin-mainz.de

Locations
Germany
Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center Not yet recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Wilfried Wagner, MD, DMD, PHD    00496131177334 ext q    wilfried.wagner@unimedizin-mainz.de   
Contact: Maximilian Moergel, MD, DMD    00496131175459    maximilian.moergel@unimedizin-mainz.de   
Principal Investigator: Wilfried Wagner, MD, DMD, PHD         
Sub-Investigator: Maximilian Moergel, MD, DMD         
Dr. M. Loeck Recruiting
Berlin, Germany, D-14199
MSc. E. Trilck Recruiting
Berlin, Germany, D-10117
Dr.Dr. U. Schwarzott Recruiting
Berlin, Germany, D-10969
Dr. G. Körner Recruiting
Bielefeld, Germany, D-33602
PD.Dr.Dr. E. Keese Recruiting
Braunschweig, Germany, D-38126
Klinik für MKG Chirurgie Dortmund Recruiting
Dortmund, Germany, D-44145
Contact: Stefan Haßfeld, MD, DMD, PHD         
Dr.Dr. V. Michalczik Recruiting
Essen, Germany, D-45259
Dr. M.Sc. Gau Recruiting
Euskirchen, Germany, D-53879
Dr. M. Schlee Recruiting
Forchheim, Germany, D-91301
Dr. Borrmann Recruiting
Freiberg, Germany, D-09599
Dr. H. Steveling Recruiting
Gernsbach, Germany, D-76593
Dr. Dr. St. Kahnel Recruiting
Hamburg, Germany, D-20095
Dr. U. Konter Recruiting
Hamburg, Germany, Hamburg
Klinik für MKG Chirurgie MH Hannover Recruiting
Hannover, Germany, D-30625
Contact: Nils-Claudius Gellrich, MD, DMD, PHD         
Contact: Jan-Thomas Krause         
K. Bothe Recruiting
Hannover, Germany, D-30169
Dr. Ch. Mertens Recruiting
Heidelberg, Germany, 69120
Dr. W. Knöfler Recruiting
Leipzig, Germany, D-04177
Dr. R. Noelken Recruiting
Lindau, Germany, 88131
Contact: Robert Noelken, DMD         
Contact: Bettina Anna Neffe         
Dr.Dr. R. Wörtche Recruiting
Lorsch, Germany, D-64653
Dr. Dr. Barth Recruiting
Mannheim, Germany, D-68183
Contact: Tilo J Barth, MD, DMD         
Dr. P. Rauch Recruiting
Melsungen, Germany, D-34212
Dr. MMsc Dirlewanger Recruiting
Nagold, Germany, 72202
Prof. Dr. H. Visser Recruiting
Oldenburg, Germany, 26122
Dr.Dr. M. Kestel Recruiting
Rückersdorf, Germany, D-90607
Dr. J. U. Wiegner Recruiting
Saalfeld, Germany, D-07318
Dr. M. Riedl Recruiting
Stein, Germany, D-90547
Tagesklinik für Kiefer- und Plastische Gesichtschirurgie Recruiting
Wiesbaden, Germany, 65183
Contact: Rainer SR Buch, MD, DMD         
Contact: Christian Küttner, MD, DMD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Dentsply Implants
Investigators
Principal Investigator: Wilfried Wagner, MD, DMD, PHD Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
  More Information

No publications provided

Responsible Party: Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01400321     History of Changes
Other Study ID Numbers: GAST
Study First Received: June 7, 2011
Last Updated: November 15, 2012
Health Authority: Germany: Institutional Ethics Committee

Keywords provided by Johannes Gutenberg University Mainz:
dental implant
soft tissue maintenance
bone remodelling
inclined atrophy

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014