Jaw, Edentulous, Partially
Conditions
Brief summary
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.
Interventions
DEVICEOsseoSpeed™ TX 3.0S
OsseoSpeed™ TX 3.0 mm diameter
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | Evaluated at implant placement and at the 5 years follow-up after implant placement | Overall implant survival rate evaluated clinically and radiographically |
Countries
Denmark, Germany, Italy, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsseoSpeed™ TX 3.0S OsseoSpeed™ TX 3.0 mm diameter | 69 |
| OsseoSpeed™ TX 3.0S OsseoSpeed™ TX 3.0 mm diameter | 97 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | OsseoSpeed™ TX 3.0S |
|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 15.11 |
| Region of Enrollment Denmark | 14 participants |
| Region of Enrollment Germany | 4 participants |
| Region of Enrollment Italy | 10 participants |
| Region of Enrollment Spain | 14 participants |
| Region of Enrollment Sweden | 15 participants |
| Region of Enrollment United Kingdom | 12 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
Primary
Implant Survival Rate
Overall implant survival rate evaluated clinically and radiographically
Time frame: Evaluated at implant placement and at the 5 years follow-up after implant placement
Population: A total of 69 subjects were enrolled in the study and received a total of 97 implants.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ | Implant Survival Rate | 93 Implants |