Tooth Loss
Conditions
Keywords
Small diameter implant
Brief summary
The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow treatment of patients with single tooth gaps of small dimensions in the lateral and central incisor positions in the mandible and in the lateral incisor positions in the maxilla. These positions are reduced-load-bearing compared to more posterior positions. During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.
Detailed description
This is a multi-center, prospective, single cohort, post-market clinical follow-up (PMCF) study. The total study duration for each patient should be 12 ± 1 months. Straumann BLT implants Ø 2.9 mm will be placed in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement, followed by provisional prosthetic loading after 6 ± 2 weeks and by final prosthetic loading 4 ± 1 months after implant placements. In total 7 visits per patient are scheduled in this study. Implant survival, PES, implant success, bone level changes and adverse events (AEs) will be assessed. The investigational device is a CE-(Conformité Européenne, meaning European Conformity) marked product. Straumann BLT implants Ø 2.9 mm Roxolid SLActive (sand blasted, large grit, acid etched surface) are available in lengths of 10, 12 and 14 mm. Four centers in Germany will participate. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.
Interventions
DEVICEBLT Implant Ø 2.9 mm
Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Sponsors
Institut Straumann AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed. * Patients must be males or females who are a minimum of 18 years of age. * Patients with a minimum of 4 weeks history of edentulism in the study area, minimal interdental space and in need of a single tooth replacement with a dental implant central and lateral incisors in the mandible and lateral incisors in the maxilla (Federation Dentaire Internationale (FDI) positions 12, 22, 31, 32, 41 or 42). * Presence of natural tooth or implants adjacent to the study implant position (single tooth gap). * Patients with complete soft tissue coverage of the socket at implant placement.
Exclusion criteria
* Patients with inadequate bone volume and / or quality or metabolic bone disorder. * Patients with local root remnants. * Patients with inadequate wound healing capacity. * Patients with not completed maxillary and mandibular growth. * Patients with serious internal medical problems, uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders. * Patients with poor general state of health. * Patients with drug or alcohol abuse. * Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy. * Patients 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. * A woman who is pregnant or planning to become pregnant at any point during the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate at 12 Months After Implant Placement | 12 months after implant placement | A surviving implant is an implant stably inserted in the subject's jaw bone at the time of assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pink Esthetic Score (PES) at 6 Months After Implant Placement | 6 months after implant placement | The Pink esthetic score allows an objective evaluation of peri-implant soft tissue of single tooth implants based on 7 variables and is highly reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. The minimum achievable PES is 0 and the maximum score is 14. The higher the value, the better the outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implant Success Rate at 12 Months After Implant Placement | 12 months after implant placement | A successful implant is an implant where all of the following success criteria (according to Buser et al., 1992) apply: 1. Absence of persisting subjective discomfort such as pain, foreign body perception and/or dysesthesia (painful sensation); 2. Absence of recurrent peri-implant infection with suppuration; 3. Absence of tactile implant mobility; 4. Absence of a continuous peri-implant radiolucency. |
| Marginal Bone Level Changes at 12 Months After Implant Placement | Baseline and 12 months after implant placement | An independent expert is contracted to perform the bone level measurements from the X-rays. The vertical bone level is evaluated by measuring the distance from the implant shoulder to the first visible bone contact on the implant. Measurements are taken at the mesial and distal aspects of the implant, and an average value is calculated. Mean bone level changes are computed by subtracting the average bone level at 12 months after implant placement from the average bone level at baseline (implant placement). Hence, negative bone level changes are representing bone loss; vice versa positive changes representing bone gain. Measurements take into account distortion based on changes on the radiograph from the true dimension of the implant. |
| Incidence of Adverse Events and Adverse Device Effects | Screening, Baseline, 7-14 days after implant placement, 6 weeks after implant placement, 4 months after implant placement, 6 months after implant placement and 12 months after implant placement | At each visit the Investigator should determine if any adverse events occurred since the last study visit by speaking with the patient and reviewing any dental and medical records. These AEs, along with any AEs from the current study visit, should be documented and reported as described in Section 8 of the protocol. In addition the Investigator should evaluate the status of any ongoing AEs throughout the study. |
Countries
Germany
Participant flow
Recruitment details
First site was initiated on 11th DEC 2015 (Mainz University). The first patient was included on 12 FEB 2016 and the last patient out was on 07 JUN 2019 (last 1-year follow-up). The last centre was closed on 10 DEC 2019 (Münster).
Pre-assignment details
This was a non-randomized study (N/A).
Participants by arm
| Arm | Count |
|---|---|
| BLT Implant Ø 2.9 mm The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.
BLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | BLT Implant Ø 2.9 mm |
|---|---|
| Age, Continuous | 44.53 years STANDARD_DEVIATION 18.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Germany | 41 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 10 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Implant Survival Rate at 12 Months After Implant Placement
A surviving implant is an implant stably inserted in the subject's jaw bone at the time of assessment.
Time frame: 12 months after implant placement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BLT Implant Ø 2.9 mm | Implant Survival Rate at 12 Months After Implant Placement | 92.68 percentage of participants |
Secondary
Pink Esthetic Score (PES) at 6 Months After Implant Placement
The Pink esthetic score allows an objective evaluation of peri-implant soft tissue of single tooth implants based on 7 variables and is highly reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. The minimum achievable PES is 0 and the maximum score is 14. The higher the value, the better the outcome.
Time frame: 6 months after implant placement
Population: 11 missing values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BLT Implant Ø 2.9 mm | Pink Esthetic Score (PES) at 6 Months After Implant Placement | 11.2 score on a scale |
Other Pre-specified
Implant Success Rate at 12 Months After Implant Placement
A successful implant is an implant where all of the following success criteria (according to Buser et al., 1992) apply: 1. Absence of persisting subjective discomfort such as pain, foreign body perception and/or dysesthesia (painful sensation); 2. Absence of recurrent peri-implant infection with suppuration; 3. Absence of tactile implant mobility; 4. Absence of a continuous peri-implant radiolucency.
Time frame: 12 months after implant placement
Population: 2 missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BLT Implant Ø 2.9 mm | Implant Success Rate at 12 Months After Implant Placement | 89.7 percentage of participants |
Other Pre-specified
Incidence of Adverse Events and Adverse Device Effects
At each visit the Investigator should determine if any adverse events occurred since the last study visit by speaking with the patient and reviewing any dental and medical records. These AEs, along with any AEs from the current study visit, should be documented and reported as described in Section 8 of the protocol. In addition the Investigator should evaluate the status of any ongoing AEs throughout the study.
Time frame: Screening, Baseline, 7-14 days after implant placement, 6 weeks after implant placement, 4 months after implant placement, 6 months after implant placement and 12 months after implant placement
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLT Implant Ø 2.9 mm | Incidence of Adverse Events and Adverse Device Effects | Adverse Events (AE) | 10 Participants |
| BLT Implant Ø 2.9 mm | Incidence of Adverse Events and Adverse Device Effects | Adverse Device Effects (ADE) | 6 Participants |
| BLT Implant Ø 2.9 mm | Incidence of Adverse Events and Adverse Device Effects | Serious Adverse Events | 0 Participants |
| BLT Implant Ø 2.9 mm | Incidence of Adverse Events and Adverse Device Effects | Serious Adverse Device Effects | 0 Participants |
| BLT Implant Ø 2.9 mm | Incidence of Adverse Events and Adverse Device Effects | Unanticipated Serious Adv. Device Effect (USADE) | 0 Participants |
| BLT Implant Ø 2.9 mm | Incidence of Adverse Events and Adverse Device Effects | No AEs | 25 Participants |
Other Pre-specified
Marginal Bone Level Changes at 12 Months After Implant Placement
An independent expert is contracted to perform the bone level measurements from the X-rays. The vertical bone level is evaluated by measuring the distance from the implant shoulder to the first visible bone contact on the implant. Measurements are taken at the mesial and distal aspects of the implant, and an average value is calculated. Mean bone level changes are computed by subtracting the average bone level at 12 months after implant placement from the average bone level at baseline (implant placement). Hence, negative bone level changes are representing bone loss; vice versa positive changes representing bone gain. Measurements take into account distortion based on changes on the radiograph from the true dimension of the implant.
Time frame: Baseline and 12 months after implant placement
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BLT Implant Ø 2.9 mm | Marginal Bone Level Changes at 12 Months After Implant Placement | -0.3 mm |