A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-12-31

Brief Summary

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This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.

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Detailed Description

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This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.

Conditions

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Edentulism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Soft bone drilling protocol

A soft bone drilling protocol will be used in bone quality 3 and 4

Group Type EXPERIMENTAL

OsseoSpeed TX

Intervention Type DEVICE

OsseoSpeed TX dental implants, 6-17 mm

Standard drilling protocol

A standard drilling protocol will be used in bone quality 1 and 2

Group Type ACTIVE_COMPARATOR

OsseoSpeed TX

Intervention Type DEVICE

OsseoSpeed TX dental implants, 6-17 mm

Interventions

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OsseoSpeed TX

OsseoSpeed TX dental implants, 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. At least 4 months healing after last grafting procedure in the study area
5. In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47
6. The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.
7. Deemed by the investigator to be suitable for one stage surgery
8. Deemed by the investigator to be suitable for immediate loading
9. Deemed by the investigator as likely to present an initially stable implant situation.
10. 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