Partially Edentulous Jaw
Conditions
Brief summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant 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 3 mm implant is a safe and predictable procedure.
Interventions
DEVICEOsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 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 study area of at least two months 4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s) 5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns 6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant 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. Uncontrolled pathologic 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 could compromise post-operative healing and/or osseointegration, as deemed by the investigator 7. Uncontrolled diabetes mellitus 8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration 9. Smoking more than 10 cigarettes per day 10. Present alcohol and/or drug abuse 11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 12. Previous enrollment in the present study 13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival | Measured at the 3-year follow-up visit after implant loading. | Implant survival rate evaluated clinically and radiographically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level Alteration | Measured at the 3-year follow-up visit after implant loading. | Marginal Bone Level (mm) determined from radiographs and expressed as a 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 obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline). |
| Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD). | Measured at implant loading and at the 3-year follow-up visit after loading. | Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
| Implant Stability | Measured at the 3-year follow-up visit after implant loading. | Implant stability evaluated clinically/manually (recorded as stable yes/no). |
| Presence of Plaque | Measured at the 3-year follow-up visit after implant loading. | Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit. |
| Gingival Zenith Score | Measured at implant loading and at the 3-year follow-up visit after loading. | Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm. Presented as change from loading of permanent restoration to time of the 3-year follow-up visit. |
| Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP). | Measured at implant loading and at the 3-year follow-up visit after loading. | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsseoSpeed™ TX OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | OsseoSpeed™ TX |
|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment China | 45 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Time frame: Measured at the 3-year follow-up visit after implant loading.
Population: Intention to treat (ITT), including all participants that received at least one implant, a total of 45 subjects (47 implants).~A total of 5 subjects (5 implants) had been lost to follow-up at time of the 3-year follow-up visit, giving an overall number of 40 subjects (42 implants) as basis for the analysis of three year survival rate.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX | Implant Survival | 42 Implants |
Secondary
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Time frame: Measured at implant loading and at the 3-year follow-up visit after loading.
Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX | Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP). | 2 implants |
Secondary
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
Change in pocket depth expressed in millimeters at time of the 3 years 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 implant loading and at the 3-year follow-up visit after loading.
Population: 40 subjects (42 implants) completed the 3 years follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX | Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD). | -0.26 millimeter | Standard Deviation 0.73 |
Secondary
Gingival Zenith Score
Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm. Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.
Time frame: Measured at implant loading and at the 3-year follow-up visit after loading.
Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX | Gingival Zenith Score | -0.03 millimeter | Standard Deviation 0.74 |
Secondary
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time frame: Measured at the 3-year follow-up visit after implant loading.
Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the All Patients Treated (APT) population.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX | Implant Stability | 42 implants |
Secondary
Marginal Bone Level Alteration
Marginal Bone Level (mm) determined from radiographs and expressed as a 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 obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).
Time frame: Measured at the 3-year follow-up visit after implant loading.
Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsseoSpeed™ TX | Marginal Bone Level Alteration | 0.52 millimeter | Standard Deviation 0.84 |
Secondary
Presence of Plaque
Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.
Time frame: Measured at the 3-year follow-up visit after implant loading.
Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsseoSpeed™ TX | Presence of Plaque | 2 implants |