Inclined Atrophy of the Distal MandibleGASTNCT01400321
PEERS Multicenter Osseospeed TM TX Profile Implant: German Astra Soft Tissue (GAST) Maintenance Study
An observational study of Inclined Atrophy of the Distal Mandible and Socket Like Atrophy of the Aesthetic Zone, run by Johannes Gutenberg University Mainz at 28 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inclined Atrophy of the Distal Mandible, Socket Like Atrophy of the Aesthetic Zone
- How many people
- 300 participants
- Where
- 28 sitesGermany
- Study dates
- Jul 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- < 18 years
- Tumour or irradiation
- bisphosphonate or cortisone intake
- Diabetes mellitus
- Mental illness or disorder with affection of compliance
- Consumption of > 20 cigarettes/day
Show all 10Show fewer
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Germany28 sites, 28 recruiting
- Recruiting
MSc. E. Trilck
Berlin, D-10117
- Recruiting
Dr.Dr. U. Schwarzott
Berlin, D-10969
- Recruiting
Dr. M. Loeck
Berlin, D-14199
- Recruiting
Dr. G. Körner
Bielefeld, D-33602
- Recruiting
PD.Dr.Dr. E. Keese
Braunschweig, D-38126
- Recruiting
Klinik für MKG Chirurgie Dortmund
Dortmund, D-44145
Stefan Haßfeld, MD, DMD, PHD
- Recruiting
Dr.Dr. V. Michalczik
Essen, D-45259
- Recruiting
Dr. M.Sc. Gau
Euskirchen, D-53879
- Recruiting
Dr. M. Schlee
Forchheim, D-91301
- Recruiting
Dr. Borrmann
Freiberg, D-09599
- Recruiting
Dr. H. Steveling
Gernsbach, D-76593
- Recruiting
Dr. Dr. St. Kahnel
Hamburg, D-20095
- Recruiting
Dr. U. Konter
Hamburg, Hamburg
- Recruiting
K. Bothe
Hanover, D-30169
- Recruiting
Klinik für MKG Chirurgie MH Hannover
Hanover, D-30625
Nils-Claudius Gellrich, MD, DMD, PHD
Jan-Thomas Krause
- Recruiting
Dr. Ch. Mertens
Heidelberg, 69120
- Recruiting
Dr. W. Knöfler
Leipzig, D-04177
- Recruiting
Dr. R. Noelken
Lindau, 88131
Robert Noelken, DMD
Bettina Anna Neffe
- Recruiting
Dr.Dr. R. Wörtche
Lorsch, D-64653
- Not yet recruiting
Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
Mainz, Rhineland-Palatinate, 55131
Wilfried Wagner, MD, DMD, PHD, 00496131177334 ext. q, wilfried.wagner@unimedizin-mainz.de
Maximilian Moergel, MD, DMD, 00496131175459, maximilian.moergel@unimedizin-mainz.de
- Recruiting
Dr. Dr. Barth
Mannheim, D-68183
Tilo J Barth, MD, DMD
- Recruiting
Dr. P. Rauch
Melsungen, D-34212
- Recruiting
Dr. MMsc Dirlewanger
Nagold, 72202
- Recruiting
Prof. Dr. H. Visser
Oldenburg, 26122
- Recruiting
Dr.Dr. M. Kestel
Rückersdorf, D-90607
- Recruiting
Dr. J. U. Wiegner
Saalfeld, D-07318
- Recruiting
Dr. M. Riedl
Stein, D-90547
- Recruiting
Tagesklinik für Kiefer- und Plastische Gesichtschirurgie
Wiesbaden, 65183
Rainer SR Buch, MD, DMD
Christian Küttner, MD, DMD
About this 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
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.
Read the 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.
- Keywords
- dental implant, soft tissue maintenance, bone remodelling, inclined atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 24 months
Secondary outcomes (4)
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).
Measured: after 24 months
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.
Measured: after 24 months
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.
Measured: after 24 months
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
Measured: over the study period (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inclined Atrophy of the Distal MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz
- Investigators
- Wilfried Wagner, MD, DMD, PHD, Principal investigator, Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400321
- Sponsor's protocol ID
- GAST
- Acronym
- GAST
- Status last verified
- Nov 2012
- First submitted
- 7 Jun 2011
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27172991
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01400321
- Acronym / sponsor ID
- GAST / GAST
- Keywords
- dental implant, soft tissue maintenance, bone remodelling, inclined atrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- < 18 years
- Tumour or irradiation
- bisphosphonate or cortisone intake
- Diabetes mellitus
- Mental illness or disorder with affection of compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Marginal bone adaption
Time frame: after 24 months
Pinc aesthetic parameter
Time frame: after 24 months
periodontal parameter
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
- Derived from this study: PubMed 27172991Schiegnitz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried Wagner, MD, DMD, PHD principal investigator
Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inclined Atrophy of the Distal Mandible and Socket Like Atrophy of the Aesthetic Zone, run by Johannes Gutenberg University Mainz at 28 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilfried Wagner, MD, DMD, PHD (00496131177334, wilfried.wagner@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: after 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012.