Clinical trial NCT01400321: PEERS Multicenter Osseospeed TM TX Profile Implant: German Astra Soft Tissue (GAST) Maintenance Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inclined Atrophy of the Distal Mandible
Socket Like Atrophy of the Aesthetic Zone
Keywords: dental implant
soft tissue maintenance
bone remodelling
inclined atrophy
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2011-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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 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

Primary outcomes:
measure: Implant survival
timeFrame: after 24 months
Secondary outcomes:
measure: Marginal bone adaption
timeFrame: after 24 months
measure: Pinc aesthetic parameter
timeFrame: after 24 months
measure: periodontal parameter
timeFrame: after 24 months
measure: Detection and description of implant related complications and other adverse and serious adverse events
timeFrame: over the study period (24 months)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: MSc. E. Trilck
city: Berlin
country: Germany
facility: Dr.Dr. U. Schwarzott
city: Berlin
country: Germany
facility: Dr. M. Loeck
city: Bielefeld
country: Germany
facility: Dr. G. Körner
city: Braunschweig
country: Germany
facility: PD.Dr.Dr. E. Keese
city: Dortmund
country: Germany
facility: Klinik für MKG Chirurgie Dortmund
city: Essen
country: Germany
facility: Dr.Dr. V. Michalczik
city: Euskirchen
country: Germany
facility: Dr. M.Sc. Gau
city: Forchheim
country: Germany
facility: Dr. M. Schlee
city: Freiberg
country: Germany
facility: Dr. Borrmann
city: Gernsbach
country: Germany
facility: Dr. H. Steveling
city: Hamburg
country: Germany
facility: Dr. Dr. St. Kahnel
city: Hamburg
country: Germany
facility: Dr. U. Konter
city: Hannover
country: Germany
facility: K. Bothe
city: Hannover
country: Germany
facility: Klinik für MKG Chirurgie MH Hannover
city: Heidelberg
country: Germany
facility: Dr. Ch. Mertens
city: Leipzig
country: Germany
facility: Dr. W. Knöfler
city: Lindau
country: Germany
facility: Dr. R. Noelken
city: Lorsch
country: Germany
facility: Dr.Dr. R. Wörtche
city: Mannheim
country: Germany
facility: Dr. Dr. Barth
city: Melsungen
country: Germany
facility: Dr. P. Rauch
city: Nagold
country: Germany
facility: Dr. MMsc Dirlewanger
city: Oldenburg
country: Germany
facility: Prof. Dr. H. Visser
city: Rückersdorf
country: Germany
facility: Dr.Dr. M. Kestel
city: Saalfeld
country: Germany
facility: Dr. J. U. Wiegner
city: Stein
country: Germany
facility: Dr. M. Riedl
city: Wiesbaden
country: Germany
facility: Tagesklinik für Kiefer- und Plastische Gesichtschirurgie
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
name: Wilfried Wagner, MD, DMD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.