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Controlled Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface

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ClinicalTrials.gov Identifier: NCT02159183
Recruitment Status : Terminated (5-Y FUP will not result in new perception, no diff. between groups at 1+3y FUP)
First Posted : June 9, 2014
Results First Posted : March 7, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Teeth Loss
Interventions Device: Standard Plus ESTA STL Roxolid implant
Device: Standard Plus STL implant
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description

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.

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.

Period Title: Analysis After the 36 Months Follow-up
Started 22 21
Completed 19 19
Not Completed 3 2
Reason Not Completed
Protocol Violation             2             1
Adverse Event             1             0
Death             0             1
Period Title: Analysis of Primary Endpoint (12 Mts)
Started 22 21
Completed 19 20
Not Completed 3 1
Reason Not Completed
Adverse Event             1             0
Protocol Violation             2             1
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
Number of participants randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
59  (13) 56  (13) 57  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
11
  50.0%
13
  61.9%
24
  55.8%
Male
11
  50.0%
8
  38.1%
19
  44.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Switzerland Number Analyzed 22 participants 21 participants 43 participants
center „Bern/Switzerland“
7
  31.8%
7
  33.3%
14
  32.6%
center „Langenthal/Switzerland“
7
  31.8%
6
  28.6%
13
  30.2%
center „Geneva/Switzerland“
5
  22.7%
5
  23.8%
10
  23.3%
center „Lausanne/Switzerland“
3
  13.6%
3
  14.3%
6
  14.0%
Full Mouth Bleeding on Probing (FMBoP)   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 22 participants 21 participants 43 participants
14.2  (6.0) 13.3  (6.2) 13.7  (6.0)
[1]
Measure Description:

Full mouth bleeding index on probing is an indicator for Oral Hygiene and is measured in percent [%].

Percentage of total surfaces with bleeding = Number of surfaces with bleeding divided by the total number of tooth surfaces x 100

Full Mouth Plaque Index (FMPI)   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 22 participants 21 participants 43 participants
18.7  (3.8) 15.9  (5.5) 17.3  (4.9)
[1]
Measure Description:

Full mouth plaque index (FMPI) is an indicator for Oral Hygiene and is measured in percent [%].

Percentage of total surfaces with plaque = number of surfaces with plaque divided by the total number of tooth surfaces x 100.

1.Primary Outcome
Title Sulcus Bleeding Index (According to Mombelli et al 1987)
Hide Description

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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 20
Overall Number of Units Analyzed
Type of Units Analyzed: Sites on teeth
76 80
Count of Units
Unit of Measure: sites on teeth
confluent bleeding -> isolated bleeding
1
   1.3%
0
   0.0%
isolated bleeding --> no bleeding
5
   6.6%
9
  11.3%
isolated bleeding --> isolated bleeding
2
   2.6%
3
   3.8%
no bleeding -> no bleeding
51
  67.1%
53
  66.3%
no bleeding -> isolated bleeding
16
  21.1%
14
  17.5%
no bleeding -> confluent bleeding
1
   1.3%
1
   1.3%
2.Secondary Outcome
Title Sulcus Bleeding Index (According to Mombelli et al 1987)
Hide Description

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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 19
Overall Number of Units Analyzed
Type of Units Analyzed: Sites on teeth
76 76
Measure Type: Number
Unit of Measure: Sites on teeth
No Bleeding 59 60
Bleeding 17 16
3.Secondary Outcome
Title Soft Tissue Healing Evaluation
Hide Description Assessment of the wound healing by classifying the implantation site (normal or compromised healing).
Time Frame 10 days and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: participants
normal healing, 10 days 22 21
normal healing, 12 weeks 22 21
4.Secondary Outcome
Title Oral Hygiene
Hide Description 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.
Time Frame Screening, 6, 12, 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis. Missing data on some patients
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: percentage of surfaces
FMBoP, screening Number Analyzed 19 participants 19 participants
14  (6) 15  (6)
FMBoP, 6 Months Number Analyzed 19 participants 18 participants
13  (6) 11  (6)
FMBoP, 1 year Number Analyzed 19 participants 19 participants
14  (5) 11  (5)
FMBoP, 3 years Number Analyzed 19 participants 19 participants
16  (8) 15  (7)
FMPI, screening Number Analyzed 19 participants 19 participants
19  (4) 16  (6)
FMPI, 6 Months Number Analyzed 19 participants 17 participants
14  (6) 14  (6)
FMPI, 1 year Number Analyzed 19 participants 19 participants
16  (5) 14  (4)
FMPI, 3 years Number Analyzed 19 participants 19 participants
17  (8) 18  (8)
5.Secondary Outcome
Title Recession of Gingival Margin Buccally and Lingually/Palatal
Hide Description 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
Time Frame 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol Analysis. Missing data of some patients.
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: mm
Difference in recession 1 yr to final loading Number Analyzed 19 participants 19 participants
-0.5  (0.9) -0.6  (1.1)
Difference in recession 3 yr to final loading Number Analyzed 19 participants 19 participants
-0.5  (1.1) -0.7  (1.1)
6.Secondary Outcome
Title Probing Pocket Depth (PPD)
Hide Description

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.

Time Frame 6 months, 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis. Missing data of some of the patients
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: mm
PPD average, 6 Months Number Analyzed 19 participants 18 participants
3.0  (0.5) 2.8  (0.4)
PPD average, 1 year Number Analyzed 19 participants 19 participants
3.1  (0.6) 2.9  (0.6)
PPD average, 3 years Number Analyzed 19 participants 19 participants
3.2  (0.8) 3.0  (0.6)
7.Secondary Outcome
Title Clinical Attachment Level (CAL)
Hide Description

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

Time Frame 6 months, 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis. Missing data of some of the patients
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: mm
CAL average, 6 months Number Analyzed 19 participants 18 participants
1.9  (0.5) 1.8  (0.7)
CAL average, 1 year Number Analyzed 19 participants 19 participants
2.0  (0.7) 2.1  (0.7)
CAL average, 3 years Number Analyzed 19 participants 19 participants
1.9  (0.7) 2.1  (0.7)
8.Secondary Outcome
Title Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
Hide Description

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.

Time Frame 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis. Missing data of some of the patients
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: mm
Bone level change from 1 year to baseline Number Analyzed 18 participants 19 participants
0.24  (0.59) 0.14  (0.3)
Bone level change from 3 years to baseline Number Analyzed 18 participants 19 participants
0.33  (0.69) 0.12  (0.3)
9.Secondary Outcome
Title Dental Implant Success and Implant Loss
Hide Description The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) Analysis
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
Patient with implant loss, 3 years
1
   4.5%
0
   0.0%
Successful after 3 years
19
  86.4%
18
  85.7%
10.Secondary Outcome
Title Adverse Events
Hide Description All subjects are monitored continuously for adverse event.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis.
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
11
  50.0%
11
  52.4%
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      1/21 (4.76%)    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      2/21 (9.52%)    
Cardiac disorders     
Death * [1]  0/22 (0.00%)  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders     
Kneeoperation *  1/22 (4.55%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ablation of a cyste in the femur *  0/22 (0.00%)  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
[1]
Patient died of heart attack
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Plus ESTA STL Roxolid Implant Standard Plus STL Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/22 (45.45%)      9/21 (42.86%)    
General disorders     
Tooth related events   2/22 (9.09%)  4 4/21 (19.05%)  5
Non-related clinical conditions *  1/22 (4.55%)  1 1/21 (4.76%)  1
Surgical and medical procedures     
Implant related events   4/22 (18.18%)  4 1/21 (4.76%)  1
Prosthetic related events   3/22 (13.64%)  3 3/21 (14.29%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Prof. Dr. med. dent., Dr. h.c., M.S. Anton Sculean
Organization: ZMK University of Bern, Clinic of Periodontology
Phone: 004131 632 25 72 ext 77
Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT02159183     History of Changes
Other Study ID Numbers: CR 01/11
First Submitted: June 3, 2014
First Posted: June 9, 2014
Results First Submitted: March 6, 2018
Results First Posted: March 7, 2019
Last Update Posted: April 2, 2019