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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inclined Atrophy of the Distal Mandible; Socket Like Atrophy of the Aesthetic Zone

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	How many implants are in situ after an observational period of 24 months (2 years). Data presentation will be a Kaplan Meier Estimate.	after 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone adaption	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).	after 24 months
Pinc aesthetic parameter	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.	after 24 months
periodontal parameter	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.	after 24 months
Detection and description of implant related complications and other adverse and serious adverse events	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	over the study period (24 months)

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: Dentsply Sirona Implants
• Investigators: Principal Investigator: Wilfried Wagner, MD, DMD, PHD, Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center

Publications and helpful links

General Publications

• Schiegnitz E, Noelken R, Moergel M, Berres M, Wagner W. Survival and tissue maintenance of an implant with a sloped configurated shoulder in the posterior mandible-a prospective multicenter study. Clin Oral Implants Res. 2017 Jun;28(6):721-726. doi: 10.1111/clr.12869. Epub 2016 May 13.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 15, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: dental implant; bone remodelling; soft tissue maintenance; inclined atrophy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: GAST