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

Dentsply

Status: Completed

Conditions: Jaw, Edentulous, Partially

Treatments: Device: OsseoSpeed™ TX 3.0S

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646113

YA-NAR-0001

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

OsseoSpeed™ TX 3.0S (Dental implant)

Experimental group

Description:

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

Treatment:

Device: OsseoSpeed™ TX 3.0S