Jaw, Edentulous
Conditions
Keywords
Jaw, Edentulous (maxilla, with poor bone quality and quantity)
Brief summary
The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24 hours. The primary objective is to investigate implant survival rate.
Interventions
DEVICEASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Aged 20 years and over * History of totally edentulous maxilla of at least three months * Radiographic finding indicating bone quality class 3 or 4 (Lekholm and Zarb) in the maxilla * Radiographic finding indicating bone quantity class C, D or E (Lekholm and Zarb) in the maxilla * Presence of natural teeth, partial prosthesis and/or implants in the mandible, within positions 35-45 (according to the FDI digit system) * Deemed by the investigator as likely to present an initially stable implant situation suitable for immediate loading.
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 in the head and neck region * History of chemotherapy within 5 years prior to surgery * Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * Uncontrolled Diabetes Mellitus * Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * History of bone augmentation in the maxilla within 6 months prior to surgery * Known pregnancy at time of enrolment * Present alcohol and/or drug abuse * Current use of tobacco or history of tobacco use within 6 months prior to surgery * Need for interpreter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | At 5-year follow-up | An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. |
Countries
Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsseoSpeed ASTRA TECH Implant System, OsseoSpeed™, all dimensions. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | OsseoSpeed |
|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 5 / 51 |
Outcome results
Primary
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Time frame: At 5-year follow-up
Population: Per protocol analysis presented, this includes implants loaded within 24 hours from implant placement (306 implants in 51 subjects), of these 20 implants failed during the 5 year follow-up period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OsseoSpeed | Implant Survival Rate | 93.10 percentage of implants |