Inclined Atrophy of the Distal Mandible Clinical Trial
— GASTOfficial 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
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Dr. M. Loeck | Berlin | |
| Germany | Dr.Dr. U. Schwarzott | Berlin | |
| Germany | MSc. E. Trilck | Berlin | |
| Germany | Dr. G. Körner | Bielefeld | |
| Germany | PD.Dr.Dr. E. Keese | Braunschweig | |
| Germany | Klinik für MKG Chirurgie Dortmund | Dortmund | |
| Germany | Dr.Dr. V. Michalczik | Essen | |
| Germany | Dr. M.Sc. Gau | Euskirchen | |
| Germany | Dr. M. Schlee | Forchheim | |
| Germany | Dr. Borrmann | Freiberg | |
| Germany | Dr. H. Steveling | Gernsbach | |
| Germany | Dr. Dr. St. Kahnel | Hamburg | |
| Germany | Dr. U. Konter | Hamburg | |
| Germany | K. Bothe | Hannover | |
| Germany | Klinik für MKG Chirurgie MH Hannover | Hannover | |
| Germany | Dr. Ch. Mertens | Heidelberg | |
| Germany | Dr. W. Knöfler | Leipzig | |
| Germany | Dr. R. Noelken | Lindau | |
| Germany | Dr.Dr. R. Wörtche | Lorsch | |
| Germany | Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center | Mainz | Rheinland-Pfalz |
| Germany | Dr. Dr. Barth | Mannheim | |
| Germany | Dr. P. Rauch | Melsungen | |
| Germany | Dr. MMsc Dirlewanger | Nagold | |
| Germany | Prof. Dr. H. Visser | Oldenburg | |
| Germany | Dr.Dr. M. Kestel | Rückersdorf | |
| Germany | Dr. J. U. Wiegner | Saalfeld | |
| Germany | Dr. M. Riedl | Stein | |
| Germany | Tagesklinik für Kiefer- und Plastische Gesichtschirurgie | Wiesbaden |
| Lead Sponsor | Collaborator |
|---|---|
| Johannes Gutenberg University Mainz | Dentsply Implants |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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) | Yes |