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The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery and 12 months post-implant placement. The secondary objectives will assess differences in clinical outcomes between the test and control implants, including implant success and survival, gingival recession, subject satisfaction and additional early bone level measurements.
This is a randomized, controlled, multi-center clinical study. The total study duration for each patient should be 12 ± 1 months.
Straumann Bone Level implants will be placed in the pre-molar or anterior region of the mandible or maxilla for single tooth replacement, followed by provisional prosthetic loading after 25 ± 4 days and by final prosthetic loading 6 ± 1 months after implant loading.
In total 6 visits per patient are scheduled in this study. Bone level changes, implant success and survival, gingival recession, subject satisfaction and adverse events (AEs) will be assessed.
The study devices are CE-(Conformité Européenne, meaning European Conformity) marked products. Straumann Bone Level implants Ø 3.3 mm NC SLActive Roxolid and Straumann Bone Level Ø 4.1 mm RC SLActive implants.
Five centers in USA will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4.1 mm implant diameter | Active Comparator | Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region |
|
| 3.3 mm implant diameter | Experimental | Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straumann Bone Level Implants, 4.1 mm implant diameter | Device | Straumann Bone Level Implants, 4.1 mm implant diameter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Crestal Bone Level Change | Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla. | Baseline (implant placement) and 12 months post loading |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Mean Crestal Bone Level Changes | Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post post implant placement, 6 months post loading, and 12 months post loading | Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L. Cochran, DDS, MS, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Dentistry | Los Angeles | California | 90095-1668 | United States | ||
| Boston University, School of Dental Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3.3 mm Implant Diameter | Placement of a Straumann Bone Level Implant, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region |
| FG001 | 4.1 mm Implant Diameter | Placement of a Straumann Bone Level Implant, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population. One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3.3 mm Implant Diameter | Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region |
| BG001 | 4.1 mm Implant Diameter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics. |
| 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 | Mean Crestal Bone Level Change | Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla. | modified Intent-to-Treat population | Posted | Mean | Standard Deviation | mm | Baseline (implant placement) and 12 months post loading |
|
Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
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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 | 3.3 mm Implant Diameter | Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prosthetic related complication | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Jork | Straumann USA, LLC | 978-747-2533 | kelly.jork@straumann.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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| Straumann Bone Level Implants, 3.3 mm implant diameter | Device | Straumann Bone Level Implants, 3.3 mm implant diameter |
|
| Implant Success Rate | Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant) | 25 days, 6 months post loading, and 12 months post loading |
| Implant Survival Rate | Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up) | 7 days, 25 days, 6 months post loading, and 12 months post loading |
| Gingival Recession | Soft tissue measurements include: CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters. | 6 months to 12 months post loading |
| Number of Participants With Adverse Events and Adverse Device Effects | Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading. The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes "possibly related", "probably related" and "related"). | Duration of the study from surgical visit to the 12 months post-loading visit |
| Subject Satisfaction | Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain. General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain) | 12 months post loading |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| New York University College of Dentistry | New York | New York | 10019-5404 | United States |
| Univeristy of Texas Health Science Center San Antonio | San Antonio | Texas | 78229 | United States |
| University of Washington | Seattle | Washington | 98195-7444 | United States |
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics. | Count of Participants | Participants |
|
| Race (NIH/OMB) | One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics. | Count of Participants | Participants |
|
| Region of Enrollment | One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics. | Count of Participants | Participants |
|
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region |
|
|
|
| Secondary | Additional Mean Crestal Bone Level Changes | Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post post implant placement, 6 months post loading, and 12 months post loading | modified Intent-to-Treat population | Posted | Mean | Standard Deviation | mm | Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading |
|
|
|
| Secondary | Implant Success Rate | Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant) | modified Intent-to-Treat population | Posted | Count of Participants | Participants | 25 days, 6 months post loading, and 12 months post loading |
|
|
|
| Secondary | Implant Survival Rate | Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up) | modified Intent-to-Treat population | Posted | Count of Participants | Participants | 7 days, 25 days, 6 months post loading, and 12 months post loading |
|
|
|
| Secondary | Gingival Recession | Soft tissue measurements include: CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters. | Modified Intent-to-Treat population. Data was not available from 4 subjects in the 3.3 mm arm and 3 subjects in the 4.1 arm | Posted | Mean | Standard Deviation | mm | 6 months to 12 months post loading |
|
|
|
| Secondary | Number of Participants With Adverse Events and Adverse Device Effects | Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading. The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes "possibly related", "probably related" and "related"). | Safety population. One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the safety population. | Posted | Count of Participants | Participants | Duration of the study from surgical visit to the 12 months post-loading visit |
|
|
|
| Secondary | Subject Satisfaction | Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain. General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain) | Modified Intent-to-Treat population. Data was not available for 3 subjects in 3.3 mm implant arm and for 2 subjects in the 4.1 mm implant arm. | Posted | Mean | Standard Deviation | units on a scale | 12 months post loading |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | 4.1 mm Implant Diameter | Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region | 0 | 25 | 1 | 25 | 13 | 25 |
| Pain at implant site | Surgical and medical procedures | Systematic Assessment |
|
| Implant hit root of adjacent tooth | Surgical and medical procedures | Systematic Assessment |
|
| Minimal bone loss around implant | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Implant mobility | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Radiolucency around implant | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Oral ulcer | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain due to bruxism | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tooth caries | General disorders | Systematic Assessment |
|
| Adjacent tooth fracutre | General disorders | Systematic Assessment |
|
| Vaginal yeast infection | Infections and infestations | Systematic Assessment |
|
| Adaptor broke in implant | Product Issues | Systematic Assessment |
|
| Burning sensation on labial mucosa | Nervous system disorders | Systematic Assessment |
|
| Post op paraesthesia lower left labial mucosa | Nervous system disorders | Systematic Assessment |
|
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| change surgery to 12 months |
|
| Not available for evaluation |
|
| 6 months post loading |
|
| 12 months post loading |
|
| Not available for evaluation |
|
| 25 days (implant loading) |
|
| 6 months post implant loading |
|
| 12 months post implant loading |
|
| IPm |
|
|
| IPd |
|
|
| CLTm |
|
|
| CLTd |
|
|
| subjects with adverse events related to device |
|
| Subjects with adverse events related to procedure |
|