Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Partial Edentulism in the Maxilla or in the Mandible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OsseoSpeed EV

OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm

Group Type EXPERIMENTAL

OsseoSpeed EV

Intervention Type DEVICE

OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm

OsseoSpeed TX

OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

Group Type ACTIVE_COMPARATOR

OsseoSpeed TX

Intervention Type DEVICE

OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

Interventions

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OsseoSpeed EV

OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm

Intervention Type DEVICE

OsseoSpeed TX

OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No