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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoSpeed™ TX | Experimental | OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ TX | Device | OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival | Implant survival rate evaluated clinically and radiographically. | Measured at the 3-year follow-up visit after implant loading. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no). | Measured at the 3-year follow-up visit after implant loading. |
| 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). |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Dehua, Prof | Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tong Ji University, Oral Implants Department | Shanghai | China | ||||
| School of Stomatology Wuhan University |
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| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed™ TX | OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed™ TX | OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 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 | Implant Survival | Implant survival rate evaluated clinically and radiographically. | 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. | Posted | Count of Units | Implants | Measured at the 3-year follow-up visit 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 narrow implants (diameter 3 mm) of lengths 11-15 mm |
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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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| Measured at the 3-year follow-up visit after implant loading. |
| 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. | 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). | 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. | Measured at implant loading and at the 3-year follow-up visit after loading. |
| 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. | Measured at the 3-year follow-up visit after implant loading. |
| 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. | Measured at implant loading and at the 3-year follow-up visit after loading. |
| Wuhan |
| 430079 |
| China |
| Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University | Xi'an | 710032 | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
| Implants |
|
|
| Secondary | Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no). | 40 subjects (42 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the All Patients Treated (APT) population. | Posted | Count of Units | implants | Measured at the 3-year follow-up visit after implant loading. | implants | 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). | 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). | Posted | Mean | Standard Deviation | millimeter | Measured at the 3-year follow-up visit after implant loading. | Implants | 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. | 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). | Posted | Mean | Standard Deviation | millimeter | Measured at implant loading and at the 3-year follow-up visit after loading. | Implants | 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. | 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). | Posted | Count of Units | implants | Measured at implant loading and at the 3-year follow-up visit after loading. | implants | implants |
|
|
|
| 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. | 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). | Posted | Count of Units | implants | Measured at the 3-year follow-up visit after implant loading. | implants | implants |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | millimeter | Measured at implant loading and at the 3-year follow-up visit after loading. | implants | implants |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |