Partially Edentulous Jaw
Conditions
Brief summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the posterior maxilla is a safe and predictable procedure.
Interventions
DEVICEOsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 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
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent 2. Aged 20-75 years at enrollment 3. History of edentulism in the posterior maxilla, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid. 4. Neighboring tooth to the planned bridge must have natural root. 5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge. 6. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm. 7. Deemed by the investigator as likely to present an initially stable implant situation
Exclusion criteria
1. Unlikely to be able to comply with study procedures, as judged by the investigator 2. Earlier graft procedures in the study area 3. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area. 4. Uncontrolled pathologic processes in the oral cavity 5. Known or suspected current malignancy 6. History of radiation therapy in the head and neck region 7. History of chemotherapy within 5 years prior to surgery 8. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration 9. Uncontrolled diabetes mellitus 10. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration 11. Smoking more than 10 cigarettes/day 12. Present alcohol and/or drug abuse 13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 14. Previous enrollment in the present study. 15. Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months. 16. Subjects that are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level Alteration | Measured at implant loading and at the 3-year follow-up after implant loading. | Marginal bone level determined from radiographs and expressed as the distance 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 3-year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Stable Implants | Measured at the 3-year follow-up after implant loading. | Implant stability evaluated clinically/manually (recorded as stable yes/no). |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | Measured at the 3-year follow-up after implant loading. | Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
| Number of Survived Implants | Measured at the 3-year follow-up after implant loading. | Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function. |
| Presence of Plaque | Measured at the 3-year follow-up after implant loading. | Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3-year follow-up visit after implant loading. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsseoSpeed™ TX OsseoSpeed™ TX implants of lengths 8-17 mm | 32 |
| OsseoSpeed™ TX OsseoSpeed™ TX implants of lengths 8-17 mm | 86 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 10 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | OsseoSpeed™ TX |
|---|---|
| Age, Continuous | 56.0 Years STANDARD_DEVIATION 11.3 |
| Region of Enrollment China | 32 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 42 |
| serious Total, serious adverse events | 3 / 42 |
Outcome results
Primary
Marginal Bone Level Alteration
Marginal bone level determined from radiographs and expressed as the distance 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 3-year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Time frame: Measured at implant loading and at the 3-year follow-up after implant loading.
Population: 36 subjects (86 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 27 subjects (66 implants). Eighteen of the radiographs were not possible to evaluate, giving an overall number of 19 subjects (48 implants) as basis for the 3-year Marginal Bone Level alteration analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX | Marginal Bone Level Alteration | -0.09 Millimeter | Standard Deviation 0.83 |
Secondary
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.
Time frame: Measured at the 3-year follow-up after implant loading.
Population: 36 subjects (86 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 27 subjects (66 implants). For two of those implants evaluation of PPD was not performed, giving 25 subjects (64 implants) as basis for the PPD analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX | Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | -0.23 Millimeter | Standard Deviation 0.9 |
Secondary
Number of Stable Implants
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time frame: Measured at the 3-year follow-up after implant loading.
Population: 36 subjects (86 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the all patients treated population.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX | Number of Stable Implants | 86 Implants |
Secondary
Number of Survived Implants
Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function.
Time frame: Measured at the 3-year follow-up after implant loading.
Population: All participants treated with at least one study implant.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX | Number of Survived Implants | 103 Implants |
Secondary
Presence of Plaque
Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3-year follow-up visit after implant loading.
Time frame: Measured at the 3-year follow-up after implant loading.
Population: 36 subjects (86 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 27 subjects (66 implants). Evaluation of plaque was not performed on two of those subjects, giving an overall number of 25 subjects (64 implants) as basis for the 3-year presence of plaque analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX | Presence of Plaque | 9 Implants |