Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-12-31

Brief Summary

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To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX

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Detailed Description

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Conditions

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Partial Edentulism Edentulism Nos

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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A

Group Type EXPERIMENTAL

OsseoSpeed TX

Intervention Type DEVICE

OsseoSpeedTM TX implants of lengths 6-17 mm

B

Group Type ACTIVE_COMPARATOR

OsseoSpeed

Intervention Type DEVICE

OsseoSpeedTM implants of lengths 6-17 mm

Interventions

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OsseoSpeed TX

OsseoSpeedTM TX implants of lengths 6-17 mm

Intervention Type DEVICE

OsseoSpeed

OsseoSpeedTM implants of lengths 6-17 mm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Provision of informed consent
2. Female/male aged 18 years and over
3. History of edentulism in the study area of at least 3 months
4. In need for implant(s) replacing missing tooth/teeth in the maxilla
5. Deemed by the investigator to be suitable for one stage surgery
6. Deemed by the investigator to be suitable for loading after 10-12 weeks
7. Deemed by the investigator as likely to present an initially stable implant situation.
8. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

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. Known or suspected current malignancy
4. History of radiation therapy in the head and neck region
5. History of chemotherapy within 5 years prior to surgery
6. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
9. Present alcohol and/or drug abuse
10. Current need for bone grafting and/or augmentation in the planned implant area
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrolment in the present study.
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No