Partially Edentulous Jaw
Conditions
Brief summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.
Interventions
DEVICEOsseoSpeed™ TX implant (Ø 4.0 mm, length 6 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. Female and male aged 20-75 years at enrolment 3. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region) 4. History of edentulism in the study area of at least four months 5. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s) 6. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns 7. Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm 8. 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. Uncontrolled pathologic processes in the oral cavity 4. Known or suspected current malignancy 5. History of radiation therapy in the head and neck region 6. History of chemotherapy within 5 years prior to surgery 7. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration 8. Uncontrolled diabetes mellitus 9. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration 10. Smoking more than 10 cigarettes/day 11. Present alcohol and/or drug abuse 12. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 13. Previous enrolment in the present study 14. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months 15. Subjects that are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level Alteration | Evaluated from implant installation to 12 months 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival | Evaluated from implant installation to 36 months after implant loading. | Implant survival rate evaluated clinically and radiographically. |
| Implant Stability | Evaluated 36 months after implant loading. | Implant stability evaluated clinically/manually (recorded as stable yes/no). |
| Condition of the Periimplant Mucosa (PPD). | Evaluated from implant loading to 36 months after implant loading. | Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Negative value = increased pocket depth |
| Marginal Bone Level Alteration After 36 Months | Evaluated from implant loading to 36 months 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading. Positive value = bone gain, Negative values = bone loss. |
| Plaque | Evaluated 36 months after implant loading. | Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit. |
| Crown-to-implant Ratio | 12 months after implant loading | Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs |
| Condition of the Periimplant Mucosa (BoP). | Evaluated from implant loading to 36 months after implant loading. | Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP). Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsseoSpeed™ TX Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. | 45 |
| OsseoSpeed™ TX Implants OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. | 94 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | OsseoSpeed™ TX Implants |
|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 10.61 |
| Region of Enrollment China | 45 participants |
| Sex: Female, Male Female | 28 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 | 6 / 45 |
| serious Total, serious adverse events | 3 / 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss.
Time frame: Evaluated from implant installation to 12 months after implant loading
Population: 45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Six of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (69 implants) as basis for the 12 months analysis of MBL change.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX Implants | Marginal Bone Level Alteration | -0.06 millimeter | Standard Deviation 0.55 |
Secondary
Condition of the Periimplant Mucosa (BoP).
Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP). Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up.
Time frame: Evaluated from implant loading to 36 months after implant loading.
Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~The BoP measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of BoP.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX Implants | Condition of the Periimplant Mucosa (BoP). | 43 Implants |
Secondary
Condition of the Periimplant Mucosa (PPD).
Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Negative value = increased pocket depth
Time frame: Evaluated from implant loading to 36 months after implant loading.
Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Baseline and/or follow-up measurements not available for 3 implants, giving an overall number of 36 subjects (72 implants) as basis for the 36 months analysis of PPD change.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX Implants | Condition of the Periimplant Mucosa (PPD). | -0.63 millimeter | Standard Deviation 0.83 |
Secondary
Crown-to-implant Ratio
Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs
Time frame: 12 months after implant loading
Population: 45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~6 of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (68 implants) as basis for 12 months analysis of Crown-to-implant ratio.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX Implants | Crown-to-implant Ratio | 1.70 Ratio | Standard Deviation 0.32 |
Secondary
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time frame: Evaluated 36 months after implant loading.
Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX Implants | Implant Stability | 75 Implants |
Secondary
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Time frame: Evaluated from implant installation to 36 months after implant loading.
Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX Implants | Implant Survival | 75 Implants |
Secondary
Marginal Bone Level Alteration After 36 Months
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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading. Positive value = bone gain, Negative values = bone loss.
Time frame: Evaluated from implant loading to 36 months after implant loading.
Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Four of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (71 implants) as basis for the 36 months analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX Implants | Marginal Bone Level Alteration After 36 Months | 0.07 millimeter | Standard Deviation 0.49 |
Secondary
Plaque
Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.
Time frame: Evaluated 36 months after implant loading.
Population: 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Plaque measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of Plaque.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX Implants | Plaque | 29 Implants |