Jaw, Edentulous, Partially
Conditions
Keywords
Dental Implant
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStraumann Bone Level Implants, 4.1 mm implant diameter
Straumann Bone Level Implants, 4.1 mm implant diameter
DEVICEStraumann Bone Level Implants, 3.3 mm implant diameter
Straumann Bone Level Implants, 3.3 mm implant diameter
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have voluntarily signed the informed consent form * Subjects must be males or females who are a minimum of 20 years of age * Subjects must have a single tooth gap in the pre-molar or anterior region of the mandible or maxilla (ADA tooth positions 4-13 and 20-29; FDI tooth positions 11-15, 21-25, 31-35, and 41-45) * Subjects must have opposing dentition (natural teeth, fixed or removable restorations) * Subjects must have a full mouth plaque score ≤ 25%, according to O'Leary, at the time of screening * Subjects must have adequate bone to encapsulate the implant and allow placement of an Ø 4.1 mm Bone Level Implant. * Adequate bone height of at least 1 mm longer than the length of the study implant * Subjects must have substantially healed (at least 16 weeks after tooth extraction) extraction sockets * Subjects must be committed to the study and the required follow-up visits * Subjects must be in good general health as assessed by the Investigator
Exclusion criteria
* Subjects with a systemic disease that would preclude dental implant surgery (e.g. serious internal medical problems, disorders of bone metabolism, uncontrolled bleeding disorders, weakened immune system, illness requiring periodic use of steroids, uncontrollable endocrine disorders, uncontrolled diabetes) * Subjects with any contraindications for oral surgical procedures (e.g. inadequate wound healing capacity, poor oral hygiene, maxillary and mandibular growth not completed, xerostomia) * Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site * Subjects with a history of local irradiation therapy in the head/neck area * Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site * Subjects receiving, or having a history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates * Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction * Subjects with existing implants in the adjacent positions to the planned implant site * Subjects requiring bone augmentation or socket grafting within 6 months prior to surgery * Subjects requiring more than minimal simultaneous augmentation for minimal buccal dehiscence defects (defect cannot be greater than 3mm in height) * Subjects with inadequate oral hygiene or who are unmotivated for adequate home care * Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene * Subjects who are pregnant or intending to become pregnant during the duration of the study * Subjects who are heavy smokers (defined as \>10 cigarettes per day or \>1 cigar per day) or chew tobacco * Subjects who abuse alcohol or drugs * Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study * Subjects with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Crestal Bone Level Change | Baseline (implant placement) and 12 months post loading | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Success Rate | 25 days, 6 months post loading, and 12 months post loading | 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) |
| Implant Survival Rate | 7 days, 25 days, 6 months post loading, and 12 months post loading | Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up) |
| Additional Mean Crestal Bone Level Changes | Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading | 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 |
| Number of Participants With Adverse Events and Adverse Device Effects | Duration of the study from surgical visit to the 12 months post-loading visit | 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). |
| Subject Satisfaction | 12 months post loading | 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) |
| Gingival Recession | 6 months to 12 months post loading | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | 3.3 mm Implant Diameter | Total | 4.1 mm Implant Diameter |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 13.96 | 51.2 years STANDARD_DEVIATION 14.04 | 49.6 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 43 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 35 Participants | 19 Participants |
| Region of Enrollment United States | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 15 Participants | 32 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 18 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 7 / 25 | 13 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 |
Outcome results
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.
Time frame: Baseline (implant placement) and 12 months post loading
Population: modified Intent-to-Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3.3 mm Implant Diameter | Mean Crestal Bone Level Change | 0.27 mm | Standard Deviation 0.34 |
| 4.1 mm Implant Diameter | Mean Crestal Bone Level Change | 0.48 mm | Standard Deviation 0.67 |
Comparison: The primary efficacy endpoint is change in crestal bone level from loading to 12 months post-loading. The primary analysis is a test for non-inferiority of the test implant to the control implant at the one-sided 5% significance level. The null hypothesis is that µ3.3 ≥ µ4.1 + δ, where µ3.3 is the mean change in crestal bone level for the test implants, µ4.1 is the mean change in crestal bone level for control implants, and δ is a pre-specified clinically significant difference.p-value: 0.02ANCOVA
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
Time frame: Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading
Population: modified Intent-to-Treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.3 mm Implant Diameter | Additional Mean Crestal Bone Level Changes | Change surgery to loading | 0.08 mm | Standard Deviation 0.15 |
| 3.3 mm Implant Diameter | Additional Mean Crestal Bone Level Changes | change surgery to 6 months | 0.52 mm | Standard Deviation 0.53 |
| 3.3 mm Implant Diameter | Additional Mean Crestal Bone Level Changes | change surgery to 12 months | 0.35 mm | Standard Deviation 0.33 |
| 4.1 mm Implant Diameter | Additional Mean Crestal Bone Level Changes | Change surgery to loading | 0.34 mm | Standard Deviation 0.38 |
| 4.1 mm Implant Diameter | Additional Mean Crestal Bone Level Changes | change surgery to 6 months | 0.73 mm | Standard Deviation 0.52 |
| 4.1 mm Implant Diameter | Additional Mean Crestal Bone Level Changes | change surgery to 12 months | 0.83 mm | Standard Deviation 0.66 |
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.
Time frame: 6 months to 12 months post loading
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.3 mm Implant Diameter | Gingival Recession | IPd | -0.5 mm | Standard Deviation 1.54 |
| 3.3 mm Implant Diameter | Gingival Recession | CLTm | 0.7 mm | Standard Deviation 2.59 |
| 3.3 mm Implant Diameter | Gingival Recession | IPm | -0.9 mm | Standard Deviation 1.4 |
| 3.3 mm Implant Diameter | Gingival Recession | CLTd | 0.8 mm | Standard Deviation 1.99 |
| 3.3 mm Implant Diameter | Gingival Recession | CLI | 0.1 mm | Standard Deviation 1.04 |
| 4.1 mm Implant Diameter | Gingival Recession | CLTd | -0.1 mm | Standard Deviation 2.53 |
| 4.1 mm Implant Diameter | Gingival Recession | CLI | 0.2 mm | Standard Deviation 2.14 |
| 4.1 mm Implant Diameter | Gingival Recession | IPm | -0.9 mm | Standard Deviation 1.96 |
| 4.1 mm Implant Diameter | Gingival Recession | CLTm | 0.1 mm | Standard Deviation 2.76 |
| 4.1 mm Implant Diameter | Gingival Recession | IPd | -0.9 mm | Standard Deviation 1.9 |
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)
Time frame: 25 days, 6 months post loading, and 12 months post loading
Population: modified Intent-to-Treat population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 3.3 mm Implant Diameter | Implant Success Rate | 25 days (implant loading) | Non successful implant | 1 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 6 months post loading | Not available for evaluation | 0 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 25 days (implant loading) | Successful implant | 25 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 12 months post loading | Successful implant | 24 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 25 days (implant loading) | Not available for evaluation | 0 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 12 months post loading | Non successful implant | 0 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 6 months post loading | Non successful implant | 0 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 12 months post loading | Not available for evaluation | 2 Participants |
| 3.3 mm Implant Diameter | Implant Success Rate | 6 months post loading | Successful implant | 26 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 12 months post loading | Not available for evaluation | 0 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 25 days (implant loading) | Successful implant | 23 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 25 days (implant loading) | Non successful implant | 1 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 25 days (implant loading) | Not available for evaluation | 0 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 6 months post loading | Non successful implant | 0 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 6 months post loading | Not available for evaluation | 1 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 12 months post loading | Successful implant | 24 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 12 months post loading | Non successful implant | 0 Participants |
| 4.1 mm Implant Diameter | Implant Success Rate | 6 months post loading | Successful implant | 23 Participants |
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)
Time frame: 7 days, 25 days, 6 months post loading, and 12 months post loading
Population: modified Intent-to-Treat population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 3.3 mm Implant Diameter | Implant Survival Rate | 12 months post implant loading | Surviving implant | 24 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 12 months post implant loading | Non-surviving implant | 0 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 12 months post implant loading | Not available for evaluation | 2 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 25 days (implant loading) | Non-surviving implant | 0 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 25 days (implant loading) | Not available for evaluation | 0 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 7 days (post-op) | Surviving implant | 26 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 7 days (post-op) | Non-surviving implant | 0 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 7 days (post-op) | Not available for evaluation | 0 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 25 days (implant loading) | Surviving implant | 26 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 6 months post implant loading | Surviving implant | 26 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 6 months post implant loading | Non-surviving implant | 0 Participants |
| 3.3 mm Implant Diameter | Implant Survival Rate | 6 months post implant loading | Not available for evaluation | 0 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 6 months post implant loading | Not available for evaluation | 1 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 7 days (post-op) | Not available for evaluation | 0 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 12 months post implant loading | Non-surviving implant | 0 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 6 months post implant loading | Non-surviving implant | 0 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 12 months post implant loading | Not available for evaluation | 0 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 25 days (implant loading) | Surviving implant | 24 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 25 days (implant loading) | Non-surviving implant | 0 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 25 days (implant loading) | Not available for evaluation | 0 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 12 months post implant loading | Surviving implant | 24 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 7 days (post-op) | Surviving implant | 24 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 6 months post implant loading | Surviving implant | 23 Participants |
| 4.1 mm Implant Diameter | Implant Survival Rate | 7 days (post-op) | Non-surviving implant | 0 Participants |
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).
Time frame: Duration of the study from surgical visit to the 12 months post-loading visit
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3.3 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | Subjects without adverse events | 18 Participants |
| 3.3 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | Subjects with adverse events related to procedure | 3 Participants |
| 3.3 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | Subjects with one or more adverse events | 7 Participants |
| 3.3 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | subjects with adverse events related to device | 1 Participants |
| 4.1 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | subjects with adverse events related to device | 5 Participants |
| 4.1 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | Subjects with adverse events related to procedure | 5 Participants |
| 4.1 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | Subjects without adverse events | 12 Participants |
| 4.1 mm Implant Diameter | Number of Participants With Adverse Events and Adverse Device Effects | Subjects with one or more adverse events | 13 Participants |
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)
Time frame: 12 months post loading
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3.3 mm Implant Diameter | Subject Satisfaction | General Satisfaction | 97.7 units on a scale | Standard Deviation 3.03 |
| 3.3 mm Implant Diameter | Subject Satisfaction | Pain | 6.0 units on a scale | Standard Deviation 19.75 |
| 4.1 mm Implant Diameter | Subject Satisfaction | General Satisfaction | 98.2 units on a scale | Standard Deviation 3.54 |
| 4.1 mm Implant Diameter | Subject Satisfaction | Pain | 2.7 units on a scale | Standard Deviation 8.05 |