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The aim of the present study is to evaluate the 1-year and 3-year survival and success of MIS® C1 implants with a length of 10-15mm.
Specific Aims
10 implants will be allocated to each of the twelve dentists, for a total of 120 implants. One test implant per patient will be allowed into the study for a total of 120 patients.
The following data will be collected for each patient/implant:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental Implants | Experimental | Rehabilitation of missing teeth with Dental Implant (MIS Technologies) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implant (MIS Technologies) | Device | MIS Technologies Ltd. C1 Dental implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | 1 year survival rate | 1 year post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 1 Year Implant Bone Level Changes | bone change in millimeters after 1 year | 1 year post implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Horwitz, DMD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 31096 | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dental Implants | Patients with missing teeth that are indicated for rehabilitation with Dental Implants (MIS Technologies) will be recruited. All the implants needed in the surgical area of the recruited patients will be allowed into the study Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dental Implants | Rehabilitation of missing teeth with Dental Implant (MIS Technologies) Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Survival Rate | 1 year survival rate | Fifteen patients (25%) received 1 implant and 45 patients (75%) received 2 or more implants. | Posted | Count of Units | dental implants | 1 year post implantation | dental implants | dental implants |
|
|
1 year
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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 | Dental Implants | Rehabilitation of missing teeth with Dental Implant (MIS Technologies) Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Trial | Rambam Health Care Campus | +97247772983 | j_horwitz@rambam.health.gov.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2013 | Mar 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| implants |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
| dental implants |
|
|
| Secondary | 1 Year Implant Bone Level Changes | bone change in millimeters after 1 year | 117 implants in 60 patients | Posted | Mean | Standard Deviation | millimeters | 1 year post implantation | dental implants | dental implants |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |