Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01400321
Recruitment Status : Unknown
Verified November 2012 by Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
First Posted : July 22, 2011
Last Update Posted : November 16, 2012
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date June 7, 2011
First Posted Date July 22, 2011
Last Update Posted Date November 16, 2012
Study Start Date July 2011
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2012)
Implant survival [ Time Frame: after 24 months ]
How many implants are in situ after an observational period of 24 months (2 years). Data presentation will be a Kaplan Meier Estimate.
Original Primary Outcome Measures
 (submitted: July 21, 2011)
Implant survival [ Time Frame: after 24 months ]
How many implants are in situ after an observational period of 24 months (2 years). Datapresentation will be a Kaplan Meier Estimate.
Change History Complete list of historical versions of study NCT01400321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 21, 2011)
  • Marginal bone adaption [ Time Frame: after 24 months ]
    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).
  • Pinc aesthetic parameter [ Time Frame: after 24 months ]
    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.
  • periodontal parameter [ Time Frame: after 24 months ]
    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.
  • Detection and description of implant related complications and other adverse and serious adverse events [ Time Frame: over the study period (24 months) ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Inclined Atrophy of the Distal Mandible
  • Socket Like Atrophy of the Aesthetic Zone
Intervention Not Provided
Study Groups/Cohorts
  • 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)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 21, 2011)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01400321
Other Study ID Numbers GAST
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz
Study 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
PRS Account Johannes Gutenberg University Mainz
Verification Date November 2012