Partially Edentulous Jaw
Conditions
Brief summary
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 mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible 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 enrolment 3. History of edentulism in the posterior mandible, 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 enrolment 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 | Evaluated 3 years after implant loading | Marginal Bone Level 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 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival | From implant placement to the follow-up 36 months after loading. | Implant survival rate evaluated clinically and radiographically. |
| Implant Stability | Measured from loading of implants to the follow-up 36 months after loading. | Implant stability evaluated clinically/manually (recorded as stable yes/no) |
| Soft Tissue Status (PPD). | Measured from loading of implants to the follow-up 36 months after loading. | Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed. A negative value = increased pocket depth. |
| Soft Tissue Status (BoP) | Measured from loading of implants to the follow-up 36 months after loading. | Soft tissue status measured by assessment of bleeding on probing (BoP). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsseoSpeed TX OsseoSpeed TX implants of lengths 8-17 mm | 45 |
| OsseoSpeed TX OsseoSpeed TX implants of lengths 8-17 mm | 107 |
| Total | 152 |
Baseline characteristics
| Characteristic | OsseoSpeed TX |
|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 10.21 |
| Region of Enrollment China | 45 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 45 |
| serious Total, serious adverse events | 1 / 45 |
Outcome results
Primary
Marginal Bone Level Alteration
Marginal Bone Level 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 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Time frame: Evaluated 3 years after implant loading
Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).~In addition a total of 2 subjects (4 implants) had radiographs were not possible measure. Giving an analysis population of 38 subjects (88 implants) for the primary outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed TX | Marginal Bone Level Alteration | 0.10 millimeter | Standard Deviation 0.61 |
Secondary
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no)
Time frame: Measured from loading of implants to the follow-up 36 months after loading.
Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed TX | Implant Stability | 92 Implants |
Secondary
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Time frame: From implant placement to the follow-up 36 months after loading.
Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed TX | Implant Survival | 92 Implants |
Secondary
Soft Tissue Status (BoP)
Soft tissue status measured by assessment of bleeding on probing (BoP).
Time frame: Measured from loading of implants to the follow-up 36 months after loading.
Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed TX | Soft Tissue Status (BoP) | 30 Implants |
Secondary
Soft Tissue Status (PPD).
Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed. A negative value = increased pocket depth.
Time frame: Measured from loading of implants to the follow-up 36 months after loading.
Population: Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed TX | Soft Tissue Status (PPD). | -0.77 millimeter | Standard Deviation 0.95 |