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5-Y FUP will not result in new perception, no diff. between groups at 1+3y FUP
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This study will investigate the effect on the soft tissue that is in contact with a dental implant with a modified surface of the neck (the part of the implant that is above the bone and in contact with the soft gum tissue).
This is a prospective, controlled, randomised clinical pilot study with parallel groups and blinded subject.
The design has been chosen to obtain data to base a sample size calculation for future studies on by comparing the degree of mucosal inflammation of the mucosa in conjunction with the modified surface of the top of the test implant and the machined surface on the top of the control implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Plus ESTA STL Roxolid implant | Experimental | 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 STL implant | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Plus ESTA STL Roxolid implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sulcus Bleeding Index (According to Mombelli et al 1987) | 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
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sulcus Bleeding Index (According to Mombelli et al 1987) | 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
| 3 years |
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Inclusion Criteria:
Exclusion Criteria:
Secondary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Sculean, Prof. Dr. | Universität Bern, Klinik für Parodontologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern | Bern | 3010 | Switzerland | |||
| University of Geneva |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Analysis After the 36 Months Follow-up |
|
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| Standard Plus STL implant | Device | 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 | Assessment of the wound healing by classifying the implantation site (normal or compromised healing). | 10 days and 12 weeks |
| Oral Hygiene | 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. | Screening, 6, 12, 36 months |
| Recession of Gingival Margin Buccally and Lingually/Palatal | 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 | 1 and 3 years |
| Probing Pocket Depth (PPD) | 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. | 6 months, 1 and 3 years |
| Clinical Attachment Level (CAL) | 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 | 6 months, 1 and 3 years |
| Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements | 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. | 1 and 3 years |
| Dental Implant Success and Implant Loss | The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success. | 3 years |
| Adverse Events | All subjects are monitored continuously for adverse event. | up to 3 years |
| Geneva |
| 1211 |
| Switzerland |
| Private Practice | Langenthal | 4900 | Switzerland |
| Ardentis Clinique Dentaire | Lausanne | 1300 | Switzerland |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Analysis of Primary Endpoint (12 Mts) |
|
|
Number of participants randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Full Mouth Bleeding on Probing (FMBoP) | 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 | Mean | Standard Deviation | % |
| ||||||||||||||
| Full Mouth Plaque Index (FMPI) | 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. | Mean | Standard Deviation | % |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sulcus Bleeding Index (According to Mombelli et al 1987) | 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
| per protocol analysis | Posted | Count of Units | sites on teeth | 12 months | sites on teeth | sites on teeth |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Sulcus Bleeding Index (According to Mombelli et al 1987) | 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
| Per-Protocol Analysis | Posted | Number | Sites on teeth | 3 years | Sites on teeth | Sites on teeth |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Soft Tissue Healing Evaluation | Assessment of the wound healing by classifying the implantation site (normal or compromised healing). | Posted | Number | participants | 10 days and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Oral Hygiene | 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. | Per-protocol analysis. Missing data on some patients | Posted | Mean | Standard Deviation | percentage of surfaces | Screening, 6, 12, 36 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Recession of Gingival Margin Buccally and Lingually/Palatal | 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 | Per protocol Analysis. Missing data of some patients. | Posted | Mean | Standard Deviation | mm | 1 and 3 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Probing Pocket Depth (PPD) | 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. | Per-Protocol Analysis. Missing data of some of the patients | Posted | Mean | Standard Deviation | mm | 6 months, 1 and 3 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Attachment Level (CAL) | 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 | Per-Protocol Analysis. Missing data of some of the patients | Posted | Mean | Standard Deviation | mm | 6 months, 1 and 3 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements | 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. | Per-Protocol Analysis. Missing data of some of the patients | Posted | Mean | Standard Deviation | mm | 1 and 3 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Dental Implant Success and Implant Loss | The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success. | Intention to Treat (ITT) Analysis | Posted | Count of Participants | Participants | 3 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events | All subjects are monitored continuously for adverse event. | ITT Analysis. | Posted | Count of Participants | Participants | up to 3 years |
|
|
36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 22 | 1 | 22 | 10 | 22 |
| EG001 | 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. | 1 | 21 | 2 | 21 | 9 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kneeoperation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Ablation of a cyste in the femur | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Death | Cardiac disorders | Non-systematic Assessment | Patient died of heart attack |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth related events | General disorders | Systematic Assessment |
| ||
| Implant related events | Surgical and medical procedures | Systematic Assessment |
| ||
| Prosthetic related events | Surgical and medical procedures | Systematic Assessment |
| ||
| Non-related clinical conditions | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. dent., Dr. h.c., M.S. Anton Sculean | ZMK University of Bern, Clinic of Periodontology | 004131 632 25 72 | 77 | anton.sculean@zmk.unibe.ch |
| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Male |
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| center "Langenthal/Switzerland" |
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| center "Geneva/Switzerland" |
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| center "Lausanne/Switzerland" |
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| isolated bleeding --> isolated bleeding |
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| no bleeding -> no bleeding |
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| no bleeding -> isolated bleeding |
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| no bleeding -> confluent bleeding |
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| Sites on teeth |
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| Units | Counts |
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| Units | Counts |
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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.
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| Participants |
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