Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2014-08-31

Brief Summary

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To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.

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Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OsseoSpeed™ TX 3.0S (Dental implant)

OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm

Group Type EXPERIMENTAL

OsseoSpeed™ TX 3.0S

Intervention Type DEVICE

OsseoSpeed™ TX 3.0 mm diameter

Interventions

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OsseoSpeed™ TX 3.0S

OsseoSpeed™ TX 3.0 mm diameter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* Aged 18-70 years at enrolment
* History of edentulism in the study area of at least two months
* Presence of natural tooth roots adjacent to the study implant position
* Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
* Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria

* Unlikely to be able to comply with study procedures, as judged by the investigator
* Uncontrolled pathologic processes in the oral cavity
* Known or suspected current malignancy
* History of radiation therapy in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
* Uncontrolled diabetes mellitus
* Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
* Smoking more than 10 cigarettes per day
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
* Previous enrolment in the present study
* Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrolment

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No