Trial Outcomes & Findings for Controlled Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface (NCT NCT02159183)
NCT ID: NCT02159183
Last Updated: 2019-04-02
Results Overview
The primary endpoint is the difference of Sulcus Bleeding Index (according to Mombelli et al 1987) between baseline (final loading) and 12 months. The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
12 months
Results posted on
2019-04-02
Participant Flow
Participant milestones
| Measure |
Standard Plus ESTA STL Roxolid Implant
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Analysis After the 36 Months Follow-up
STARTED
|
22
|
21
|
|
Analysis After the 36 Months Follow-up
COMPLETED
|
19
|
19
|
|
Analysis After the 36 Months Follow-up
NOT COMPLETED
|
3
|
2
|
|
Analysis of Primary Endpoint (12 Mts)
STARTED
|
22
|
21
|
|
Analysis of Primary Endpoint (12 Mts)
COMPLETED
|
19
|
20
|
|
Analysis of Primary Endpoint (12 Mts)
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Standard Plus ESTA STL Roxolid Implant
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Analysis After the 36 Months Follow-up
Protocol Violation
|
2
|
1
|
|
Analysis After the 36 Months Follow-up
Adverse Event
|
1
|
0
|
|
Analysis After the 36 Months Follow-up
Death
|
0
|
1
|
|
Analysis of Primary Endpoint (12 Mts)
Adverse Event
|
1
|
0
|
|
Analysis of Primary Endpoint (12 Mts)
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Controlled Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface
Baseline characteristics by cohort
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 13 • n=5 Participants
|
56 years
STANDARD_DEVIATION 13 • n=7 Participants
|
57 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland · center "Bern/Switzerland"
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland · center "Langenthal/Switzerland"
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland · center "Geneva/Switzerland"
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland · center "Lausanne/Switzerland"
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Full Mouth Bleeding on Probing (FMBoP)
|
14.2 %
STANDARD_DEVIATION 6.0 • n=5 Participants
|
13.3 %
STANDARD_DEVIATION 6.2 • n=7 Participants
|
13.7 %
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Full Mouth Plaque Index (FMPI)
|
18.7 %
STANDARD_DEVIATION 3.8 • n=5 Participants
|
15.9 %
STANDARD_DEVIATION 5.5 • n=7 Participants
|
17.3 %
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: per protocol analysis
The primary endpoint is the difference of Sulcus Bleeding Index (according to Mombelli et al 1987) between baseline (final loading) and 12 months. The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=76 sites on teeth
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=80 sites on teeth
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
confluent bleeding -> isolated bleeding
|
1 sites on teeth
|
0 sites on teeth
|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
isolated bleeding --> no bleeding
|
5 sites on teeth
|
9 sites on teeth
|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
isolated bleeding --> isolated bleeding
|
2 sites on teeth
|
3 sites on teeth
|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
no bleeding -> no bleeding
|
51 sites on teeth
|
53 sites on teeth
|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
no bleeding -> isolated bleeding
|
16 sites on teeth
|
14 sites on teeth
|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
no bleeding -> confluent bleeding
|
1 sites on teeth
|
1 sites on teeth
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Per-Protocol Analysis
The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=76 Sites on teeth
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=76 Sites on teeth
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
No Bleeding
|
59 Sites on teeth
|
60 Sites on teeth
|
|
Sulcus Bleeding Index (According to Mombelli et al 1987)
Bleeding
|
17 Sites on teeth
|
16 Sites on teeth
|
SECONDARY outcome
Timeframe: 10 days and 12 weeksAssessment of the wound healing by classifying the implantation site (normal or compromised healing).
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Soft Tissue Healing Evaluation
normal healing, 10 days
|
22 participants
|
21 participants
|
|
Soft Tissue Healing Evaluation
normal healing, 12 weeks
|
22 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Screening, 6, 12, 36 monthsPopulation: Per-protocol analysis. Missing data on some patients
Full mouth plaque index (FMPI) and full mouth bleeding on probing index (FMBoP) will be recorded as an indicator for the Oral Hygiene. The indexes are given in percent \[%\] calculated as the total numbers of surfaces with plaque or bleeding divided by the total number of teeth surfaces x100.
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Oral Hygiene
FMBoP, screening
|
14 percentage of surfaces
Standard Deviation 6
|
15 percentage of surfaces
Standard Deviation 6
|
|
Oral Hygiene
FMBoP, 6 Months
|
13 percentage of surfaces
Standard Deviation 6
|
11 percentage of surfaces
Standard Deviation 6
|
|
Oral Hygiene
FMBoP, 1 year
|
14 percentage of surfaces
Standard Deviation 5
|
11 percentage of surfaces
Standard Deviation 5
|
|
Oral Hygiene
FMBoP, 3 years
|
16 percentage of surfaces
Standard Deviation 8
|
15 percentage of surfaces
Standard Deviation 7
|
|
Oral Hygiene
FMPI, screening
|
19 percentage of surfaces
Standard Deviation 4
|
16 percentage of surfaces
Standard Deviation 6
|
|
Oral Hygiene
FMPI, 6 Months
|
14 percentage of surfaces
Standard Deviation 6
|
14 percentage of surfaces
Standard Deviation 6
|
|
Oral Hygiene
FMPI, 1 year
|
16 percentage of surfaces
Standard Deviation 5
|
14 percentage of surfaces
Standard Deviation 4
|
|
Oral Hygiene
FMPI, 3 years
|
17 percentage of surfaces
Standard Deviation 8
|
18 percentage of surfaces
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 1 and 3 yearsPopulation: Per protocol Analysis. Missing data of some patients.
The recession of the gingival margin will be measured (distance from the gingival margin to the crown/implant margin) by using an UNC 15 periodontal probe. Changes in (averaged) recession at the follow-up visits 12+36 months compared to baseline visit ( final loading ) are displayed
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Recession of Gingival Margin Buccally and Lingually/Palatal
Difference in recession 1 yr to final loading
|
-0.5 mm
Standard Deviation 0.9
|
-0.6 mm
Standard Deviation 1.1
|
|
Recession of Gingival Margin Buccally and Lingually/Palatal
Difference in recession 3 yr to final loading
|
-0.5 mm
Standard Deviation 1.1
|
-0.7 mm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 6 months, 1 and 3 yearsPopulation: Per-Protocol Analysis. Missing data of some of the patients
The PPD will be measured from the mucosal margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Probing pocket depth (mm) - average over buccal, palatal, distal and mesial measurements.
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Probing Pocket Depth (PPD)
PPD average, 6 Months
|
3.0 mm
Standard Deviation 0.5
|
2.8 mm
Standard Deviation 0.4
|
|
Probing Pocket Depth (PPD)
PPD average, 1 year
|
3.1 mm
Standard Deviation 0.6
|
2.9 mm
Standard Deviation 0.6
|
|
Probing Pocket Depth (PPD)
PPD average, 3 years
|
3.2 mm
Standard Deviation 0.8
|
3.0 mm
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 6 months, 1 and 3 yearsPopulation: Per-Protocol Analysis. Missing data of some of the patients
The CAL will be measured from the crown margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Clinical attachment level (mm) - average over buccal, palatal, distal and mesial measurements
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Clinical Attachment Level (CAL)
CAL average, 6 months
|
1.9 mm
Standard Deviation 0.5
|
1.8 mm
Standard Deviation 0.7
|
|
Clinical Attachment Level (CAL)
CAL average, 1 year
|
2.0 mm
Standard Deviation 0.7
|
2.1 mm
Standard Deviation 0.7
|
|
Clinical Attachment Level (CAL)
CAL average, 3 years
|
1.9 mm
Standard Deviation 0.7
|
2.1 mm
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 1 and 3 yearsPopulation: Per-Protocol Analysis. Missing data of some of the patients
Periapical radiographs are used to measure changes in mesial and distal bone crest levels (of the implant) from baseline (final loading) to one (1) year and three (3) years, respectively. The parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements. 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 periapical x-rays using an image analysis computer programme. Bone levels are averaged over mesial+distal measurements. Since bone levels were measured from the implant shoulder, an increase in bone level over time corresponds to bone loss.
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
Bone level change from 1 year to baseline
|
0.24 mm
Standard Deviation 0.59
|
0.14 mm
Standard Deviation 0.3
|
|
Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
Bone level change from 3 years to baseline
|
0.33 mm
Standard Deviation 0.69
|
0.12 mm
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Intention to Treat (ITT) Analysis
The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Dental Implant Success and Implant Loss
Patient with implant loss, 3 years
|
1 Participants
|
0 Participants
|
|
Dental Implant Success and Implant Loss
Successful after 3 years
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: ITT Analysis.
All subjects are monitored continuously for adverse event.
Outcome measures
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 Participants
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Adverse Events
|
11 Participants
|
11 Participants
|
Adverse Events
Standard Plus ESTA STL Roxolid Implant
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Standard Plus STL Implant
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 participants at risk
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 participants at risk
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Kneeoperation
|
4.5%
1/22 • 36 months
|
0.00%
0/21 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ablation of a cyste in the femur
|
0.00%
0/22 • 36 months
|
4.8%
1/21 • 36 months
|
|
Cardiac disorders
Death
|
0.00%
0/22 • 36 months
|
4.8%
1/21 • 36 months
|
Other adverse events
| Measure |
Standard Plus ESTA STL Roxolid Implant
n=22 participants at risk
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
|
Standard Plus STL Implant
n=21 participants at risk
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
|
|---|---|---|
|
General disorders
Tooth related events
|
9.1%
2/22 • Number of events 4 • 36 months
|
19.0%
4/21 • Number of events 5 • 36 months
|
|
Surgical and medical procedures
Implant related events
|
18.2%
4/22 • Number of events 4 • 36 months
|
4.8%
1/21 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Prosthetic related events
|
13.6%
3/22 • Number of events 3 • 36 months
|
14.3%
3/21 • Number of events 4 • 36 months
|
|
General disorders
Non-related clinical conditions
|
4.5%
1/22 • Number of events 1 • 36 months
|
4.8%
1/21 • Number of events 1 • 36 months
|
Additional Information
Prof. Dr. med. dent., Dr. h.c., M.S. Anton Sculean
ZMK University of Bern, Clinic of Periodontology
Phone: 004131 632 25 72
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60