An interventional study of Straumann Bone Level Implants, 4.1 mm implant diameter and Straumann Bone Level Implants, 3.3 mm implant diameter in Jaw, Edentulous, Partially, sponsored by Institut Straumann AG. Completed at 5 sites in United States. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-15.
Sponsored by Institut Straumann AG · Not applicable, Interventional, and Treatment
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.
171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.
This study's enrollment of 50 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →Institut Straumann AG is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
Device: Straumann Bone Level Implants, 4.1 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
Device: Straumann Bone Level Implants, 3.3 mm implant diameter
Straumann Bone Level Implants, 4.1 mm implant diameter
Straumann Bone Level Implants, 3.3 mm implant diameter
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.
Time frame: Baseline (implant placement) and 12 months post loading
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
Time frame: Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading
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)
Time frame: 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)
Time frame: 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.
Time frame: 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").
Time frame: 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)
Time frame: 12 months post loading
| Milestone | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| Started | 25 | 25 |
| Randomized | 25 | 25 |
| Completed | 24 | 24 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
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.
| mm | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| Mean Crestal Bone Level Change | 0.27 ± 0.34 | 0.48 ± 0.67 |
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
| mm | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| Change surgery to loading | 0.08 ± 0.15 | 0.34 ± 0.38 |
| change surgery to 6 months | 0.52 ± 0.53 | 0.73 ± 0.52 |
| change surgery to 12 months | 0.35 ± 0.33 | 0.83 ± 0.66 |
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)
| Participants | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| 25 days (implant loading) — Successful implant | 25 | 23 |
| 25 days (implant loading) — Non successful implant | 1 | 1 |
| 25 days (implant loading) — Not available for evaluation | 0 | 0 |
| 6 months post loading — Successful implant | 26 | 23 |
| 6 months post loading — Non successful implant | 0 | 0 |
| 6 months post loading — Not available for evaluation | 0 | 1 |
| 12 months post loading — Successful implant | 24 | 24 |
| 12 months post loading — Non successful implant | 0 | 0 |
| 12 months post loading — Not available for evaluation | 2 | 0 |
Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
| Participants | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| 7 days (post-op) — Surviving implant | 26 | 24 |
| 7 days (post-op) — Non-surviving implant | 0 | 0 |
| 7 days (post-op) — Not available for evaluation | 0 | 0 |
| 25 days (implant loading) — Surviving implant | 26 | 24 |
| 25 days (implant loading) — Non-surviving implant | 0 | 0 |
| 25 days (implant loading) — Not available for evaluation | 0 | 0 |
| 6 months post implant loading — Surviving implant | 26 | 23 |
| 6 months post implant loading — Non-surviving implant | 0 | 0 |
| 6 months post implant loading — Not available for evaluation | 0 | 1 |
| 12 months post implant loading — Surviving implant | 24 | 24 |
| 12 months post implant loading — Non-surviving implant | 0 | 0 |
| 12 months post implant loading — Not available for evaluation | 2 | 0 |
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.
| mm | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| CLI | 0.1 ± 1.04 | 0.2 ± 2.14 |
| IPm | -0.9 ± 1.4 | -0.9 ± 1.96 |
| IPd | -0.5 ± 1.54 | -0.9 ± 1.90 |
| CLTm | 0.7 ± 2.59 | 0.1 ± 2.76 |
| CLTd | 0.8 ± 1.99 | -0.1 ± 2.53 |
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").
| Participants | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| Subjects without adverse events | 18 | 12 |
| Subjects with one or more adverse events | 7 | 13 |
| subjects with adverse events related to device | 1 | 5 |
| Subjects with adverse events related to procedure | 3 | 5 |
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)
| units on a scale | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| General Satisfaction | 97.7 ± 3.03 | 98.2 ± 3.54 |
| Pain | 6.0 ± 19.75 | 2.7 ± 8.05 |
Collected over Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3.3 mm Implant Diameter | 0/25 (0%) | 0/25 (0%) | 7/25 (28%) |
| 4.1 mm Implant Diameter | 0/25 (0%) | 1/25 (4%) | 13/25 (52%) |
| Event | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| SeizureNervous system disorders | 0/25 | 1/25 |
| Event | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter |
|---|---|---|
| Prosthetic related complicationSurgical and medical procedures | 5/25 | 4/25 |
| Pain at implant siteSurgical and medical procedures | 0/25 | 1/25 |
| Implant hit root of adjacent toothSurgical and medical procedures | 0/25 | 1/25 |
| Minimal bone loss around implantMusculoskeletal and connective tissue disorders | 0/25 | 1/25 |
| Implant mobilityMusculoskeletal and connective tissue disorders | 1/25 | 1/25 |
| Radiolucency around implantMusculoskeletal and connective tissue disorders | 0/25 | 1/25 |
| Oral ulcerMusculoskeletal and connective tissue disorders | 1/25 | 1/25 |
| Pain due to bruxismMusculoskeletal and connective tissue disorders | 1/25 | 0/25 |
| Tooth cariesGeneral disorders | 0/25 | 1/25 |
| Adjacent tooth fracutreGeneral disorders | 1/25 | 0/25 |
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.
| Age, Continuous(years) | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter | Total |
|---|---|---|---|
| Mean | 52.9 ± 13.96 | 49.6 ± 14.20 | 51.2 ± 14.04 |
| Sex: Female, Male(Participants) | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 10 | 8 | 18 |
| Ethnicity (NIH/OMB)(Participants) | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 7 |
| Not Hispanic or Latino | 22 | 21 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 7 | 5 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 16 | 19 | 35 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | 3.3 mm Implant Diameter | 4.1 mm Implant Diameter | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
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Institut Straumann AG