Clinical trial NCT01528215: Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
Official title: An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism in the Maxilla or in the Mandible
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.


Eligibility criteria: Inclusion Criteria:

1. Provision of Informed Consent.
2. 18 -75 years at enrollment.
3. In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
4. History of edentulism in the planned implant area of at least 3 months (at Visit 2).
5. At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
6. Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
7. Deemed by the investigator to be suitable for loading after 6-8 weeks.
8. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator.
2. Uncontrolled pathological processes in the oral cavity.
3. Untreated, uncontrolled caries and/or periodontal disease.
4. Known or suspected current malignancy.
5. History of radiation therapy in the head and neck region.
6. History of chemotherapy within 5 years prior to surgery.
7. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration, as deemed by the investigator.
8. Uncontrolled diabetes mellitus.
9. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration.
10. Smoking more than 10 cigarettes per day.
11. Present alcohol and/or drug abuse.
12. Current need for bone grafting and/or augmentation in the planned implant area. Local, minor soft tissue grafting will be allowed.
13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site).
14. Previous enrollment in the present study.
15. Simultaneous participation in other clinical studies at enrollment (Visit 1) and during the subject's first year of this study.

Primary outcomes:
measure: Marginal Bone Level Change After 1 Year in Use.
timeFrame: Evaluated at implant loading and at the 1 year follow-up after implant loading.
Secondary outcomes:
measure: Marginal Bone Level Change After 5 Years in Use.
timeFrame: Evaluated from implant loading to the 5 years follow-up after implant loading.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Dows Institute for Dental Research, University of Iowa, College of Dentistry
state: Iowa
city: Ghent
country: Belgium
facility: University Hospital Ghent, Dental School Department Periodontology
city: Frankfurt am Main
country: Germany
facility: Dep. of Prosthodontics, Goethe University
city: Padova
country: Italy
facility: Dental private practice, Denis Cecchinato
Study officials:
affiliation: University of Illinois at Chicago, College of Dentistry
name: Clark M Stanford, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869.