Edentulism Nos, Partial Edentulism
Conditions
Keywords
Edentulism in the Upper Jaw
Brief summary
To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX
Interventions
DEVICEOsseoSpeed TX
OsseoSpeedTM TX implants of lengths 6-17 mm
DEVICEOsseoSpeed
OsseoSpeedTM implants of lengths 6-17 mm
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level | One year after loading | Marginal Bone Level will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability | At implant placement (inclusion) (day 1) | Implant stability will be evaluated clinically/manually (recorded as stable yes/no) |
| Implant survival | One year after loading | Implant survival rate will be evaluated by clinically and radiographically counting the number of remaining implants from implant placement to one year after loading. |
Countries
Sweden
Outcome results
None listed