Jaw, Edentulous, Partially
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStraumann® 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)
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* General inclusion criteria * Males and females, age 18 to 75 years of age (the subjects should be legally able to give informed consent to the procedure; age limitation is also present to avoid inclusion of subjects with incomplete cranio-facial growth). * Absence of relevant medical conditions. Patients with contributing medical history in which any elective oral surgical intervention would be contraindicated should be excluded. In particular patients with uncontrolled or poorly controlled diabetes, or unstable or life threatening conditions should be excluded. * Absence of uncontrolled or untreated periodontal disease. * Absence of untreated caries lesions. * Patient in good medical and psychological health as documented by self assessment * Patient's availability for follow-up according to the protocol. * Local inclusion criteria * A single tooth replacement is required in the incisor, canine, pre-molar and first molar region. Multiple-implant restorations (non adjacent to the test implant) can be performed during the study (not to be included as test implants). * at least 8 weeks post extraction where the soft tissues of the socket have healed * Presence of at least one adjacent tooth * Presence of adequate native bone to achieve primary stability
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months | 2 years after implant placement | No of participants with prosthetic related complications and with implant failures are described after 24 months |
| Probing Pocket Depth | Recorded at 16 weeks, 6, 12, and 24 months after implant placement | 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) |
| Gingival Recessions (REC) | Recorded at 16 weeks, 6, 12 and 24 months after implant placement | 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) |
| Number of Participants With Survival Rate of the Implants at 12 and 24 Months | 1 year and 2 years after implant placement | The survival rate of the implants is presented as a cumulative survival rate at 1 year and 2 years post-implant placement. |
| Adverse Events | From randomization to 2 years after implant placement | Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration |
| Soft Tissue Changes, Pink Aesthetic Score | Recorded at 12 and 24 months after implant placement | 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. |
| Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | Recorded at 12 and 24 months after implant placement | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 14 |
| 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) | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | 2- Delayed Loading | Total | 1- Immediately Provisionalized |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 27 Participants | 13 Participants |
| Age, Continuous | 47.9 years | 45.3 years | 42.1 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Female | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 14 | 12 / 14 |
| serious Total, serious adverse events | 0 / 14 | 2 / 14 |
Outcome results
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.
Time frame: between baseline and one year post treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1- Immediately Provisionalized | Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment | 0.73 mm | Standard Deviation 0.83 |
| 2- Delayed Loading | Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment | 0.22 mm | Standard Deviation 0.46 |
Secondary
Adverse Events
Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration
Time frame: From randomization to 2 years after implant placement
Population: Patient 218 discontinued the study after 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1- Immediately Provisionalized | Adverse Events | AE at 12 months | 15 events |
| 1- Immediately Provisionalized | Adverse Events | AE 12 - 24 months | 7 events |
| 2- Delayed Loading | Adverse Events | AE at 12 months | 22 events |
| 2- Delayed Loading | Adverse Events | AE 12 - 24 months | 6 events |
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)
Time frame: Recorded at 16 weeks, 6, 12 and 24 months after implant placement
Population: Patient 218 discontinued the study after 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1- Immediately Provisionalized | Gingival Recessions (REC) | REC difference 16weeks-6months | 0.1 mm | Standard Deviation 0.2 |
| 1- Immediately Provisionalized | Gingival Recessions (REC) | REC difference 16weeks-12months | 0.2 mm | Standard Deviation 0.3 |
| 1- Immediately Provisionalized | Gingival Recessions (REC) | Recession at 24 months | 0.2 mm | Standard Deviation 0.4 |
| 2- Delayed Loading | Gingival Recessions (REC) | REC difference 16weeks-6months | 0.4 mm | Standard Deviation 0.3 |
| 2- Delayed Loading | Gingival Recessions (REC) | REC difference 16weeks-12months | 0.5 mm | Standard Deviation 0.4 |
| 2- Delayed Loading | Gingival Recessions (REC) | Recession at 24 months | 0.5 mm | Standard Deviation 0.3 |
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
Time frame: 2 years after implant placement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1- Immediately Provisionalized | No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months | Number of prosthetic related complications | 1 participants |
| 1- Immediately Provisionalized | No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months | Number of implant failures | 0 participants |
| 2- Delayed Loading | No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months | Number of implant failures | 0 participants |
| 2- Delayed Loading | No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months | Number of prosthetic related complications | 1 participants |
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.
Time frame: Recorded at 12 and 24 months after implant placement
Population: Patient 218 discontinued the study after 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 0=absent papilla | 0 Participants |
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 1=incomplete Papilla 1/3 of full | 2 Participants |
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 2=incomplete papilla 2/3 of full | 6 Participants |
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 3=complete papilla | 2 Participants |
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 0=absent papilla | 0 Participants |
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 1=incomplete Papilla 1/3 of full | 1 Participants |
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 2=incomplete papille 2/3 of full | 5 Participants |
| 1- Immediately Provisionalized | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 3=complete papilla | 4 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 3=complete papilla | 6 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 0=absent papilla | 0 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 0=absent papilla | 0 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 1=incomplete Papilla 1/3 of full | 2 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 2=incomplete papille 2/3 of full | 7 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 2=incomplete papilla 2/3 of full | 6 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 24m: 1=incomplete Papilla 1/3 of full | 0 Participants |
| 2- Delayed Loading | Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index | PFI 12m: 3=complete papilla | 6 Participants |
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.
Time frame: 1 year and 2 years after implant placement
Population: Survival rate of the implants at 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1- Immediately Provisionalized | Number of Participants With Survival Rate of the Implants at 12 and 24 Months | No. of participants w. implant survival of 12mts | 14 Participants |
| 1- Immediately Provisionalized | Number of Participants With Survival Rate of the Implants at 12 and 24 Months | No. of participants w. implant survival of 24mts | 14 Participants |
| 2- Delayed Loading | Number of Participants With Survival Rate of the Implants at 12 and 24 Months | No. of participants w. implant survival of 12mts | 14 Participants |
| 2- Delayed Loading | Number of Participants With Survival Rate of the Implants at 12 and 24 Months | No. of participants w. implant survival of 24mts | 14 Participants |
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)
Time frame: Recorded at 16 weeks, 6, 12, and 24 months after implant placement
Population: Difference of Probing Pocket Depth (PPD) between 16 weeks (loading) and 6 months, 12 months and 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1- Immediately Provisionalized | Probing Pocket Depth | PPD difference 16weeks-6months | -0.3 mm | Standard Deviation 0.5 |
| 1- Immediately Provisionalized | Probing Pocket Depth | PPD difference 16weeks-12 months | -0.4 mm | Standard Deviation 0.8 |
| 1- Immediately Provisionalized | Probing Pocket Depth | PPD difference 16weeks-24 months | -0.1 mm | Standard Deviation 0.7 |
| 2- Delayed Loading | Probing Pocket Depth | PPD difference 16weeks-6months | -0.5 mm | Standard Deviation 0.7 |
| 2- Delayed Loading | Probing Pocket Depth | PPD difference 16weeks-12 months | -0.7 mm | Standard Deviation 0.9 |
| 2- Delayed Loading | Probing Pocket Depth | PPD difference 16weeks-24 months | -0.8 mm | Standard Deviation 1 |
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.
Time frame: Recorded at 12 and 24 months after implant placement
Population: Patient 218 discontinued the study after 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1- Immediately Provisionalized | Soft Tissue Changes, Pink Aesthetic Score | PES at 12 months | 11.4 score on a scale | Standard Deviation 1.2 |
| 1- Immediately Provisionalized | Soft Tissue Changes, Pink Aesthetic Score | PES at 24 months | 11.6 score on a scale | Standard Deviation 1.3 |
| 2- Delayed Loading | Soft Tissue Changes, Pink Aesthetic Score | PES at 12 months | 11.6 score on a scale | Standard Deviation 1 |
| 2- Delayed Loading | Soft Tissue Changes, Pink Aesthetic Score | PES at 24 months | 11.6 score on a scale | Standard Deviation 0.7 |