Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population

Dentsply

Status: Completed

Conditions: Partially Edentulous Jaw

Treatments: Device: OsseoSpeed™ TX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473355

CHN-0003

Details and patient eligibility

About

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.

Enrollment: 45 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent
2. Aged 20-75 years at enrolment
3. History of edentulism in the study area of at least two months
4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
6. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Uncontrolled pathologic 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 could compromise post-operative healing and/or osseointegration, as deemed by the investigator
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
9. Smoking more than 10 cigarettes per day
10. Present alcohol and/or drug abuse
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrollment in the present study
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

OsseoSpeed™ TX

Experimental group

Description:

OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm

Treatment:

Device: OsseoSpeed™ TX