Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

Dentsply

Status: Completed

Conditions: Edentulism Nos; Partial Edentulism

Treatments: Device: OsseoSpeed; Device: OsseoSpeed TX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324778

YA-OTX-0001

Details and patient eligibility

About

To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. In need for implant(s) replacing missing tooth/teeth in the maxilla
5. Deemed by the investigator to be suitable for one stage surgery
6. Deemed by the investigator to be suitable for loading after 10-12 weeks
7. Deemed by the investigator as likely to present an initially stable implant situation.
8. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

A

Experimental group

Treatment:

Device: OsseoSpeed TX

B

Active Comparator group

Treatment:

Device: OsseoSpeed