A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading

Dentsply

Status: Completed

Conditions: Edentulism

Treatments: Device: OsseoSpeed TX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340170

YA-OTX-0002

Details and patient eligibility

About

This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.

Full description

This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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. At least 4 months healing after last grafting procedure in the study area
5. In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47
6. The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.
7. Deemed by the investigator to be suitable for one stage surgery
8. Deemed by the investigator to be suitable for immediate loading
9. Deemed by the investigator as likely to present an initially stable implant situation.
10. 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Soft bone drilling protocol

Experimental group

Description:

A soft bone drilling protocol will be used in bone quality 3 and 4

Treatment:

Device: OsseoSpeed TX

Standard drilling protocol

Active Comparator group

Description:

A standard drilling protocol will be used in bone quality 1 and 2

Treatment:

Device: OsseoSpeed TX