Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoSpeed™ TX | Experimental | OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 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 |
|---|---|---|
| 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. |
| 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). |
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ping Gong, Prof | Sichuan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Stomatology, JiLin University, Hospital of Stomatology | Changchun | China | ||||
| Sichuan University |
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed™ TX | OsseoSpeed™ TX narrow implant (diameter 3 mm) in lengths of 11-15 mm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed™ TX | OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 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 | 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 |
|
|
3 year
Not provided
Not provided
| 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) in lengths of 11-15 mm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture left leg | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | ClinicalResearchMolndal@dentsplysirona.com |
Not provided
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measured at the 3 year follow-up after implant loading. |
| 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 | 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. |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of 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 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 years follow-up visit after implant loading. | Measured at the 3 year follow-up after implant loading. |
| Chengdu |
| 610041 |
| China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| Implants |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Implants |
|
|
| Secondary | 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). | 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants). Three of the radiographs were not possible to evaluate, giving an overall number of 32 subjects (57 implants) as basis for the Marginal Bone Level analysis. | Posted | Mean | Standard Deviation | millimeter | Measured at the 3 year follow-up after implant loading. | Implants | Implants |
|
|
|
| Secondary | Number of Stable Implants | Implant stability evaluated clinically/manually (recorded as stable yes/no). | 39 subjects (65 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. | 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the PPD analysis. | Posted | Mean | Standard Deviation | millimeter | Measured at the 3 year follow-up after implant loading. | Implants | Implants |
|
|
|
| Secondary | Evaluation of the Periimplant Mucosa Condition - By Assessment of 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. | 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the BoP analysis. | 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 years follow-up visit after implant loading. | 39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the plaque analysis. | Posted | Count of Units | Implants | Measured at the 3 year follow-up after implant loading. | Implants | Implants |
|
|
|
| 2 |
| 45 |
| 0 |
| 45 |
| Possible ablepsia of right eye | Eye disorders | Non-systematic Assessment |
|
Not provided
| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |