Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible 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 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 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 at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). | Evaluated 3 years after implant loading |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival | Implant survival rate evaluated clinically and radiographically. | From implant placement to the follow-up 36 months after loading. |
| Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no) |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yongsheng Zhou, Prof | Department of Prosthodontics, School of Stomatology, Beijing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Prosthodontics, School of Stomatology, Beijing University | Beijing | 100081 | China | |||
| Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26790007 | Result | Zhou J, Huang Q, Wang X, Peng D, Li Y, Zhang L, Liu J, Zhang S, Zhao K, Jiang X, Zhou Y. Early loading of splinted implants in the posterior mandible: a prospective multicentre case series. J Clin Periodontol. 2016 Mar;43(3):298-304. doi: 10.1111/jcpe.12513. Epub 2016 Mar 1. |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed TX | OsseoSpeed TX implants of lengths 8-17 mm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| 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 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 at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). | Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants). In addition a total of 2 subjects (4 implants) had radiographs were not possible measure. Giving an analysis population of 38 subjects (88 implants) for the primary outcome measure. | Posted | Mean | Standard Deviation | millimeter | Evaluated 3 years after implant loading | Implants | Implants |
|
3 years
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 implants of lengths 8-17 mm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Infections and infestations | Systematic Assessment |
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 from loading of implants to the follow-up 36 months after loading. |
| Soft Tissue Status (PPD). | Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed. A negative value = increased pocket depth. | Measured from loading of implants to the follow-up 36 months after loading. |
| Soft Tissue Status (BoP) | Soft tissue status measured by assessment of bleeding on probing (BoP). | Measured from loading of implants to the follow-up 36 months after loading. |
| Guangzhou |
| 510055 |
| China |
| Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University | Shanghai | 200011 | China |
| Implants |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
|
| Secondary | Implant Survival | Implant survival rate evaluated clinically and radiographically. | Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants). | Posted | Count of Units | Implants | From implant placement to the follow-up 36 months after loading. | Implants | Implants |
|
|
|
| Secondary | Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no) | Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants). | Posted | Count of Units | Implants | Measured from loading of implants to the follow-up 36 months after loading. | Implants | Implants |
|
|
|
| Secondary | Soft Tissue Status (PPD). | Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed. A negative value = increased pocket depth. | Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants). | Posted | Mean | Standard Deviation | millimeter | Measured from loading of implants to the follow-up 36 months after loading. | Implants | Implants |
|
|
|
| Secondary | Soft Tissue Status (BoP) | Soft tissue status measured by assessment of bleeding on probing (BoP). | Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants). | Posted | Count of Units | Implants | Measured from loading of implants to the follow-up 36 months after loading. | Implants | Implants |
|
|
|
| 1 |
| 45 |
| 3 |
| 45 |
Not provided
| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |