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

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Unknown status

CT.gov ID

NCT01400321

Collaborator

Dentsply Sirona Implants (Industry)

300

Enrollment

Locations

Duration (Months)

10.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inclined Atrophy of the Distal Mandible Socket Like Atrophy of the Aesthetic Zone

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

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Implant survival [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.

Secondary Outcome Measures

Marginal bone adaption [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center	Mainz	Rheinland-Pfalz	Germany	55131
2	MSc. E. Trilck	Berlin		Germany	D-10117
3	Dr.Dr. U. Schwarzott	Berlin		Germany	D-10969
4	Dr. M. Loeck	Berlin		Germany	D-14199
5	Dr. G. Körner	Bielefeld		Germany	D-33602
6	PD.Dr.Dr. E. Keese	Braunschweig		Germany	D-38126
7	Klinik für MKG Chirurgie Dortmund	Dortmund		Germany	D-44145
8	Dr.Dr. V. Michalczik	Essen		Germany	D-45259
9	Dr. M.Sc. Gau	Euskirchen		Germany	D-53879
10	Dr. M. Schlee	Forchheim		Germany	D-91301
11	Dr. Borrmann	Freiberg		Germany	D-09599
12	Dr. H. Steveling	Gernsbach		Germany	D-76593
13	Dr. Dr. St. Kahnel	Hamburg		Germany	D-20095
14	Dr. U. Konter	Hamburg		Germany	Hamburg
15	K. Bothe	Hannover		Germany	D-30169
16	Klinik für MKG Chirurgie MH Hannover	Hannover		Germany	D-30625
17	Dr. Ch. Mertens	Heidelberg		Germany	69120
18	Dr. W. Knöfler	Leipzig		Germany	D-04177
19	Dr. R. Noelken	Lindau		Germany	88131
20	Dr.Dr. R. Wörtche	Lorsch		Germany	D-64653
21	Dr. Dr. Barth	Mannheim		Germany	D-68183
22	Dr. P. Rauch	Melsungen		Germany	D-34212
23	Dr. MMsc Dirlewanger	Nagold		Germany	72202
24	Prof. Dr. H. Visser	Oldenburg		Germany	26122
25	Dr.Dr. M. Kestel	Rückersdorf		Germany	D-90607
26	Dr. J. U. Wiegner	Saalfeld		Germany	D-07318
27	Dr. M. Riedl	Stein		Germany	D-90547
28	Tagesklinik für Kiefer- und Plastische Gesichtschirurgie	Wiesbaden		Germany	65183