Jaw, Edentulous, Partially
Conditions
Brief summary
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.
Interventions
DEVICEAstra Tech Fixture ST
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 75 * Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid * Willing to give informed consent
Exclusion criteria
* Bone height \< 5 mm, in the planned implant area * Bone width \< 5 mm, in the planned implant area * Previous bone augmentation procedure in the planned implant area * Previous failures of endosseous implants * Untreated caries and/or periodontal disease of residual dentition * History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Current alcohol or drug abuse * Unable or unwilling to return for follow-up visits for 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | At follow-up visit: 6 months after implants have been loaded | An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Failure | 3 years after implant placement | Total number of implants reported as failure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Astra Tech Fixture ST Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Implant failure | 1 |
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Astra Tech Fixture ST |
|---|---|
| Age Continuous | 61.0 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 2 / 19 |
Outcome results
Primary
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time frame: At follow-up visit: 6 months after implants have been loaded
Population: Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Astra Tech Fixture ST | Implant Survival Rate | 89.9 Percentage of implants |
Primary
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time frame: At follow-up visit: 1 year after implants have been loaded
Population: Population includes subjects who completed 12 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Astra Tech Fixture ST | Implant Survival Rate | 89.9 Percentage of implants |
Primary
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time frame: At follow-up visit: 2 years after implants have been loaded
Population: Population includes subjects who completed 24 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Astra Tech Fixture ST | Implant Survival Rate | 89.9 Percentage of implants |
Primary
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time frame: At follow-up visit: 3 years after implants have been loaded
Population: Population includes subjects who completed 36 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Astra Tech Fixture ST | Implant Survival Rate | 89.9 Percentage of implants |
Secondary
Implant Failure
Total number of implants reported as failure.
Time frame: 3 years after implant placement
Population: Number of failed implants based on total number of patients enrolled and total number of placed implants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Astra Tech Fixture ST | Implant Failure | 7 Number of implants |