Trial Outcomes & Findings for The Role of Immediate Provisional Restorations on Bone Level Implants (NCT NCT00906165)
NCT ID: NCT00906165
Last Updated: 2019-03-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
between baseline and one year post treatment
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1- Immediately Provisionalized
n=14 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
27 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=28 Participants
|
|
Age, Continuous
|
42.1 years
n=14 Participants
|
47.9 years
n=14 Participants
|
45.3 years
n=28 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
18 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=14 Participants
|
5 Participants
n=14 Participants
|
10 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: between baseline and one year post treatmentThe 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.
Outcome measures
| Measure |
1- Immediately Provisionalized
n=10 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
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
|
0.22 mm
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 1 year and 2 years after implant placementPopulation: Survival rate of the implants at 12 months
The survival rate of the implants is presented as a cumulative survival rate at 1 year and 2 years post-implant placement.
Outcome measures
| Measure |
1- Immediately Provisionalized
n=14 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
Number of Participants With Survival Rate of the Implants at 12 and 24 Months
No. of participants w. implant survival of 12mts
|
14 Participants
|
14 Participants
|
|
Number of Participants With Survival Rate of the Implants at 12 and 24 Months
No. of participants w. implant survival of 24mts
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 2 years after implant placementNo of participants with prosthetic related complications and with implant failures are described after 24 months
Outcome measures
| Measure |
1- Immediately Provisionalized
n=14 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months
Number of prosthetic related complications
|
1 participants
|
1 participants
|
|
No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months
Number of implant failures
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Recorded at 16 weeks, 6, 12, and 24 months after implant placementPopulation: Difference of Probing Pocket Depth (PPD) between 16 weeks (loading) and 6 months, 12 months and 24 months
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)
Outcome measures
| Measure |
1- Immediately Provisionalized
n=10 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
Probing Pocket Depth
PPD difference 16weeks-6months
|
-0.3 mm
Standard Deviation 0.5
|
-0.5 mm
Standard Deviation 0.7
|
|
Probing Pocket Depth
PPD difference 16weeks-12 months
|
-0.4 mm
Standard Deviation 0.8
|
-0.7 mm
Standard Deviation 0.9
|
|
Probing Pocket Depth
PPD difference 16weeks-24 months
|
-0.1 mm
Standard Deviation 0.7
|
-0.8 mm
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Recorded at 16 weeks, 6, 12 and 24 months after implant placementPopulation: Patient 218 discontinued the study after 12 months
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)
Outcome measures
| Measure |
1- Immediately Provisionalized
n=10 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
Gingival Recessions (REC)
REC difference 16weeks-6months
|
0.1 mm
Standard Deviation 0.2
|
0.4 mm
Standard Deviation 0.3
|
|
Gingival Recessions (REC)
REC difference 16weeks-12months
|
0.2 mm
Standard Deviation 0.3
|
0.5 mm
Standard Deviation 0.4
|
|
Gingival Recessions (REC)
Recession at 24 months
|
0.2 mm
Standard Deviation 0.4
|
0.5 mm
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Recorded at 12 and 24 months after implant placementPopulation: Patient 218 discontinued the study after 12 months
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.
Outcome measures
| Measure |
1- Immediately Provisionalized
n=10 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 12m: 1=incomplete Papilla 1/3 of full
|
2 Participants
|
2 Participants
|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 12m: 0=absent papilla
|
0 Participants
|
0 Participants
|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 12m: 2=incomplete papilla 2/3 of full
|
6 Participants
|
6 Participants
|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 12m: 3=complete papilla
|
2 Participants
|
6 Participants
|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 24m: 0=absent papilla
|
0 Participants
|
0 Participants
|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 24m: 1=incomplete Papilla 1/3 of full
|
1 Participants
|
0 Participants
|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 24m: 2=incomplete papille 2/3 of full
|
5 Participants
|
7 Participants
|
|
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
PFI 24m: 3=complete papilla
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From randomization to 2 years after implant placementPopulation: Patient 218 discontinued the study after 12 months
Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration
Outcome measures
| Measure |
1- Immediately Provisionalized
n=14 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
Adverse Events
AE at 12 months
|
15 events
|
22 events
|
|
Adverse Events
AE 12 - 24 months
|
7 events
|
6 events
|
SECONDARY outcome
Timeframe: Recorded at 12 and 24 months after implant placementPopulation: Patient 218 discontinued the study after 12 months
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.
Outcome measures
| Measure |
1- Immediately Provisionalized
n=14 Participants
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)
|
2- Delayed Loading
n=14 Participants
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)
|
|---|---|---|
|
Soft Tissue Changes, Pink Aesthetic Score
PES at 12 months
|
11.4 score on a scale
Standard Deviation 1.2
|
11.6 score on a scale
Standard Deviation 1.0
|
|
Soft Tissue Changes, Pink Aesthetic Score
PES at 24 months
|
11.6 score on a scale
Standard Deviation 1.3
|
11.6 score on a scale
Standard Deviation 0.7
|
Adverse Events
1- Immediately Provisionalized
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
2- Delayed Loading
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1- Immediately Provisionalized
n=14 participants at risk
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)
|
2- Delayed Loading
n=14 participants at risk
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)
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/14
|
7.1%
1/14
|
|
Cardiac disorders
Cardiac ablation
|
0.00%
0/14
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/14
|
7.1%
1/14
|
Other adverse events
| Measure |
1- Immediately Provisionalized
n=14 participants at risk
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)
|
2- Delayed Loading
n=14 participants at risk
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)
|
|---|---|---|
|
Product Issues
Implant or procedure related complications
|
21.4%
3/14
|
7.1%
1/14
|
|
Product Issues
Prosthetic related complication
|
14.3%
2/14
|
50.0%
7/14
|
|
General disorders
clinical conditions
|
28.6%
4/14
|
28.6%
4/14
|
Additional Information
Professor N Donos
UCL Eastman Dental lnstitute University College London
Phone: +4420 3456 1075
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60