Study on OsseoSpeed™ TX Short Implants in a Chinese Population

Dentsply

Status: Completed

Conditions: Partially Edentulous Jaw

Treatments: Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01346696

CHN-0005

Details and patient eligibility

About

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.

Enrollment: 45 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent
2. Female and male aged 20-75 years at enrolment
3. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
4. History of edentulism in the study area of at least four months
5. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
6. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
7. Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
8. 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. Earlier graft procedures in the study area
3. Uncontrolled pathologic processes in the oral cavity
4. Known or suspected current malignancy
5. History of radiation therapy in the head and neck region
6. History of chemotherapy within 5 years prior to surgery
7. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
8. Uncontrolled diabetes mellitus
9. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
10. Smoking more than 10 cigarettes/day
11. Present alcohol and/or drug abuse
12. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
13. Previous enrolment in the present study
14. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
15. Subjects that are unable to give informed consent

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 implants

Experimental group

Description:

OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.

Treatment:

Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)