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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoSpeed™ TX | Experimental | OsseoSpeed™ TX implants of lengths 8-17 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ TX | Device | OsseoSpeed™ TX implants of lengths 8-17 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured at implant loading and at the 3-year follow-up after implant loading. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Stable Implants | Implant stability evaluated clinically/manually (recorded as stable yes/no). | Measured at the 3-year follow-up after implant loading. |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deng Feilong, MD | Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University School of Stomatology, Centre of Oral Implantation | Beijing | 100050 | China | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed™ TX | OsseoSpeed™ TX implants of lengths 8-17 mm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population = Per Protocol Population. I.e. Protocol deviators excluded, a total of 10 subjects with 24 implants.
| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed™ TX | OsseoSpeed™ TX implants of lengths 8-17 mm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | Millimeter | Measured at implant loading and at the 3-year follow-up after implant loading. | Implants | Implants |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OsseoSpeed™ TX | OsseoSpeed™ TX implants of lengths 8-17 mm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paralytic stroke | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insufficient osseointegration of the implant during healing phase | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | ClinicalResearchMolndal@dentsplysirona.com |
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| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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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.
| Measured at the 3-year follow-up after implant loading. |
| Number of Survived Implants | Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function. | Measured at the 3-year follow-up after implant loading. |
| 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. | Measured at the 3-year follow-up after implant loading. |
| Guanghua School of Stomatology, Sun Yat-Sen University |
| Guangzhou |
| 510055 |
| China |
| Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University | Nanjing | 210008 | China |
| Implants |
|
| Years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
OsseoSpeed™ TX implants of lengths 8-17 mm
|
|
| Secondary | Number of Stable Implants | Implant stability evaluated clinically/manually (recorded as stable yes/no). | 36 subjects (86 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the all patients treated population. | Posted | Count of Units | Implants | Measured at the 3-year follow-up after implant loading. | Implants | Implants |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Millimeter | Measured at the 3-year follow-up after implant loading. | Implants | Implants |
|
|
|
| Secondary | Number of Survived Implants | Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function. | All participants treated with at least one study implant. | Posted | Count of Units | Implants | Measured at the 3-year follow-up after implant loading. | Implants | 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. | 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. | Posted | Count of Units | Implants | Measured at the 3-year follow-up after implant loading. | Implants | Implants |
|
|
|
| 3 |
| 42 |
| 7 |
| 42 |
| Adenocarcinoma of urinary bladder | Renal and urinary disorders | Systematic Assessment |
|
| Femur Neck Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |