Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01400321
Status:
UNKNOWN
Last Update Posted:
2012-11-16
First Post:
2011-06-07
Brief Title:
PEERS Multicenter Osseospeed TM TX Profile Implant German Astra Soft Tissue GAST Maintenance Study
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAST
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None