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The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and immediately provisionalised versus the same type of implants placed in healed alveolar ridge but not provisionalised. In both cases the implants will be loaded at 16 weeks (final restorations). The outcomes will be evaluated over a 2-year period.
This is a prospective, randomised, controlled, single blind, and single center study. The total study duration for each patient should be 24 months.
Straumann Bone Level Ø 4.1 mm SLActive implants will be placed for single tooth replacement, followed by either immediate provisional prosthetic loading or no provisionalised. The final prosthetic loading is made at 16 weeks after implant loading. The implant length will be selected according to the clinical indication of the site based on previous radiographic evaluation.
In total 11 visits per patient are scheduled in this study. Bone level changes, implant success and survival rate, soft tissue changes, aesthetic outcome and adverse events (AEs) will be assessed.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products.
One center in the United Kingdom will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- Immediately provisionalized | Active Comparator | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. |
|
| 2- Delayed Loading | Active Comparator | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straumann® Bone Level SLActive Implant (4.1mm diameter) | Device | Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment | The primary parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements at baseline and one year after implant placement. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants, on digitized standardized peri-apical x-rays using an image analysis computer program. | between baseline and one year post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Survival Rate of the Implants at 12 and 24 Months | The survival rate of the implants is presented as a cumulative survival rate at 1 year and 2 years post-implant placement. | 1 year and 2 years after implant placement |
| No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months |
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Inclusion Criteria:
General inclusion criteria
Local inclusion criteria
Exclusion Criteria:
General exclusion criteria
Local exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nikos Donos, Prof. Dr. | Eastman Dental Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastman Dental Institute, University College London | London | WC1X8LD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1- Immediately Provisionalized | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) |
| FG001 | 2- Delayed Loading | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1- Immediately Provisionalized | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) |
| 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 | Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment | The primary parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements at baseline and one year after implant placement. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants, on digitized standardized peri-apical x-rays using an image analysis computer program. | Posted | Mean | Standard Deviation | mm | between baseline and one year post treatment |
|
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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 | 1- Immediately Provisionalized | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | Non-systematic Assessment | Hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant or procedure related complications | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor N Donos | UCL Eastman Dental lnstitute University College London | +4420 3456 1075 | n.donos@eastman.ucl.ac.uk |
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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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|
No of participants with prosthetic related complications and with implant failures are described after 24 months |
| 2 years after implant placement |
| Probing Pocket Depth | The Probing Pocket Depth around the implants will be measured using a UNC-15 probe with light probing force (0.2N) at the post-implant time-points specified. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants) | Recorded at 16 weeks, 6, 12, and 24 months after implant placement |
| Gingival Recessions (REC) | The gingival recessions around the implants are recorded at the above-specified timepoints after implant placement, using a UNC-15 probe. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants) | Recorded at 16 weeks, 6, 12 and 24 months after implant placement |
| Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | Soft tissue changes: mesial and distal gingival papilla dimensions assessed by Papilla Fill Index (PFI, Jemt 1997) and the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above. | Recorded at 12 and 24 months after implant placement |
| Adverse Events | Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration | From randomization to 2 years after implant placement |
| Soft Tissue Changes, Pink Aesthetic Score | Soft tissue changes: the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above. The PES index includes assessment of seven variables and each variable is measured with a 2, 1, or 0 score with 2 being the best and 0 being the poorest score. Based on its definition the PES is a cumulative score with 14 being the best and 0 the worst. | Recorded at 12 and 24 months after implant placement |
| BG001 | 2- Delayed Loading | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 2- Delayed Loading | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) |
|
|
| Secondary | Number of Participants With Survival Rate of the Implants at 12 and 24 Months | The survival rate of the implants is presented as a cumulative survival rate at 1 year and 2 years post-implant placement. | Survival rate of the implants at 12 months | Posted | Count of Participants | Participants | 1 year and 2 years after implant placement |
|
|
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| Secondary | No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months | No of participants with prosthetic related complications and with implant failures are described after 24 months | Posted | Number | participants | 2 years after implant placement |
|
|
|
| Secondary | Probing Pocket Depth | The Probing Pocket Depth around the implants will be measured using a UNC-15 probe with light probing force (0.2N) at the post-implant time-points specified. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants) | Difference of Probing Pocket Depth (PPD) between 16 weeks (loading) and 6 months, 12 months and 24 months | Posted | Mean | Standard Deviation | mm | Recorded at 16 weeks, 6, 12, and 24 months after implant placement |
|
|
|
| Secondary | Gingival Recessions (REC) | The gingival recessions around the implants are recorded at the above-specified timepoints after implant placement, using a UNC-15 probe. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants) | Patient 218 discontinued the study after 12 months | Posted | Mean | Standard Deviation | mm | Recorded at 16 weeks, 6, 12 and 24 months after implant placement |
|
|
|
| Secondary | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | Soft tissue changes: mesial and distal gingival papilla dimensions assessed by Papilla Fill Index (PFI, Jemt 1997) and the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above. | Patient 218 discontinued the study after 12 months | Posted | Count of Participants | Participants | Recorded at 12 and 24 months after implant placement |
|
|
|
| Secondary | Adverse Events | Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration | Patient 218 discontinued the study after 12 months | Posted | Number | events | From randomization to 2 years after implant placement |
|
|
|
| Secondary | Soft Tissue Changes, Pink Aesthetic Score | Soft tissue changes: the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above. The PES index includes assessment of seven variables and each variable is measured with a 2, 1, or 0 score with 2 being the best and 0 being the poorest score. Based on its definition the PES is a cumulative score with 14 being the best and 0 the worst. | Patient 218 discontinued the study after 12 months | Posted | Mean | Standard Deviation | score on a scale | Recorded at 12 and 24 months after implant placement |
|
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|
| 0 |
| 14 |
| 9 |
| 14 |
| EG001 | 2- Delayed Loading | The Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration. Straumann® Bone Level SLActive Implant (4.1mm diameter): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration) | 2 | 14 | 12 | 14 |
| Cardiac ablation | Cardiac disorders | Non-systematic Assessment | Hospitalization |
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| Lung infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization |
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| Prosthetic related complication | Product Issues | Systematic Assessment | any Event related to the prosthetic procedures |
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| clinical conditions | General disorders | Non-systematic Assessment | Condition found during visit. Events not related to device or procedure |
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| PPD difference 16weeks-12 months |
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| PPD difference 16weeks-24 months |
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| REC difference 16weeks-12months |
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| Recession at 24 months |
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| PFI 12m: 1=incomplete Papilla 1/3 of full |
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| PFI 12m: 2=incomplete papilla 2/3 of full |
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| PFI 12m: 3=complete papilla |
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| PFI 24m: 0=absent papilla |
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| PFI 24m: 1=incomplete Papilla 1/3 of full |
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| PFI 24m: 2=incomplete papille 2/3 of full |
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| PFI 24m: 3=complete papilla |
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| AE 12 - 24 months |
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| PES at 24 months |
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