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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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dental implant soft tissue maintenance bone remodelling inclined atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Distal region

Patients with loss of tooth in the premolar and molar region of the atrophied mandible

No interventions assigned to this group

aesthetic zone

Patients with loss of tooth within the aesthetic zone (canine to canine)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Prof. Dr. Dr. Wilfried Wagner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wilfried Wagner, MD, DMD, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center

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Wilfried Wagner, MD, DMD, PHD

Role: CONTACT

Phone: 00496131177334

Reference Type DERIVED

PMID: 27172991 (View on PubMed)

Other Identifiers

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GAST

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Distal region

aesthetic zone

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Dentsply Sirona Implants and Consumables

Johannes Gutenberg University Mainz

Responsible Party

Prof. Dr. Dr. Wilfried Wagner

Principal Investigators

Wilfried Wagner, MD, DMD, PHD

Locations

Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center

MSc. E. Trilck

Dr.Dr. U. Schwarzott

Dr. M. Loeck

Dr. G. Körner

PD.Dr.Dr. E. Keese

Klinik für MKG Chirurgie Dortmund

Dr.Dr. V. Michalczik

Dr. M.Sc. Gau

Dr. M. Schlee

Dr. Borrmann

Dr. H. Steveling

Dr. Dr. St. Kahnel

Dr. U. Konter

K. Bothe

Klinik für MKG Chirurgie MH Hannover

Dr. Ch. Mertens

Dr. W. Knöfler

Dr. R. Noelken

Dr.Dr. R. Wörtche

Dr. Dr. Barth

Dr. P. Rauch

Dr. MMsc Dirlewanger

Prof. Dr. H. Visser

Dr.Dr. M. Kestel

Dr. J. U. Wiegner

Dr. M. Riedl

Tagesklinik für Kiefer- und Plastische Gesichtschirurgie

Countries

Central Contacts

Wilfried Wagner, MD, DMD, PHD

Maximilian Moergel, MD, DMD

Facility Contacts

Wilfried Wagner, MD, DMD, PHD

Maximilian Moergel, MD, DMD

Stefan Haßfeld, MD, DMD, PHD

Nils-Claudius Gellrich, MD, DMD, PHD

Jan-Thomas Krause

Robert Noelken, DMD

Bettina Anna Neffe

Tilo J Barth, MD, DMD

Rainer SR Buch, MD, DMD

Christian Küttner, MD, DMD

References

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.

Other Identifiers

GAST