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

November 15, 2012 updated by: Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, D-10117
        • Recruiting
        • MSc. E. Trilck
      • Berlin, Germany, D-10969
        • Recruiting
        • Dr.Dr. U. Schwarzott
      • Berlin, Germany, D-14199
        • Recruiting
        • Dr. M. Loeck
      • Bielefeld, Germany, D-33602
        • Recruiting
        • Dr. G. Körner
      • Braunschweig, Germany, D-38126
        • Recruiting
        • PD.Dr.Dr. E. Keese
      • Dortmund, Germany, D-44145
        • Recruiting
        • Klinik für MKG Chirurgie Dortmund
        • Contact:
          • Stefan Haßfeld, MD, DMD, PHD
      • Essen, Germany, D-45259
        • Recruiting
        • Dr.Dr. V. Michalczik
      • Euskirchen, Germany, D-53879
        • Recruiting
        • Dr. M.Sc. Gau
      • Forchheim, Germany, D-91301
        • Recruiting
        • Dr. M. Schlee
      • Freiberg, Germany, D-09599
        • Recruiting
        • Dr. Borrmann
      • Gernsbach, Germany, D-76593
        • Recruiting
        • Dr. H. Steveling
      • Hamburg, Germany, D-20095
        • Recruiting
        • Dr. Dr. St. Kahnel
      • Hamburg, Germany, Hamburg
        • Recruiting
        • Dr. U. Konter
      • Hannover, Germany, D-30169
        • Recruiting
        • K. Bothe
      • Hannover, Germany, D-30625
        • Recruiting
        • Klinik für MKG Chirurgie MH Hannover
        • Contact:
          • Nils-Claudius Gellrich, MD, DMD, PHD
        • Contact:
          • Jan-Thomas Krause
      • Heidelberg, Germany, 69120
        • Recruiting
        • Dr. Ch. Mertens
      • Leipzig, Germany, D-04177
        • Recruiting
        • Dr. W. Knöfler
      • Lindau, Germany, 88131
        • Recruiting
        • Dr. R. Noelken
        • Contact:
          • Robert Noelken, DMD
        • Contact:
          • Bettina Anna Neffe
      • Lorsch, Germany, D-64653
        • Recruiting
        • Dr.Dr. R. Wörtche
      • Mannheim, Germany, D-68183
        • Recruiting
        • Dr. Dr. Barth
        • Contact:
          • Tilo J Barth, MD, DMD
      • Melsungen, Germany, D-34212
        • Recruiting
        • Dr. P. Rauch
      • Nagold, Germany, 72202
        • Recruiting
        • Dr. MMsc Dirlewanger
      • Oldenburg, Germany, 26122
        • Recruiting
        • Prof. Dr. H. Visser
      • Rückersdorf, Germany, D-90607
        • Recruiting
        • Dr.Dr. M. Kestel
      • Saalfeld, Germany, D-07318
        • Recruiting
        • Dr. J. U. Wiegner
      • Stein, Germany, D-90547
        • Recruiting
        • Dr. M. Riedl
      • Wiesbaden, Germany, 65183
        • Recruiting
        • Tagesklinik für Kiefer- und Plastische Gesichtschirurgie
        • Contact:
          • Rainer SR Buch, MD, DMD
        • Contact:
          • Christian Küttner, MD, DMD
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Not yet recruiting
        • Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wilfried Wagner, MD, DMD, PHD
        • Sub-Investigator:
          • Maximilian Moergel, MD, DMD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
after 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
after 24 months
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.
after 24 months
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.
after 24 months
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
over the study period (24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johannes Gutenberg University Mainz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dentsply Sirona Implants

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wilfried Wagner, MD, DMD, PHD, Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GAST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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