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The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.
The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTRA TECH Implant System, OsseoSpeed™ | Device | ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement | Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone. | At baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal. | 21 weeks, 12 months, 24 months and 36 months post implant placement. |
| Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tord Berglundh, Prof. | Department of Periodontology, Sahlgrenska Academy at University of Gothenburg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, College of Dental Medicine, Nova Southeastern University | Fort Lauderdale | Florida | 33328-2018 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23210667 | Result | Noelken R, Donati M, Fiorellini J, Gellrich NC, Parker W, Wada K, Berglundh T. Soft and hard tissue alterations around implants placed in an alveolar ridge with a sloped configuration. Clin Oral Implants Res. 2014 Jan;25(1):3-9. doi: 10.1111/clr.12079. Epub 2012 Dec 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Treated With OsseoSpeed™ Profile Implant | ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Treated With ASTRA TECH Implant System, OsseoSpeed™ Profile Implant | ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement | Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone. | Per-protocol analysis set | Posted | Mean | Standard Deviation | mm | At baseline and 16 weeks | Implants | Implants |
|
Up to 3 years post implant placement
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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 | ASTRA TECH Implant System, OsseoSpeed™ Profile | ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip surgery | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Affairs | DENTSPLY Implants | +46313763500 | ClinicalResearchMolndal@dentsplysirona.com |
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MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis. |
| Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement |
| Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) | BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site. | 21 weeks, 12 months, 24 months, and 36 months post implant placement |
| Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level. | Baseline and 12 months, 24 months, and 36 months post implant placement |
| Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration | CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level. | Baseline and 12 months, 24 months, and 36 months post implant placement |
| Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Praxis Dr Robert Nölken | Lindau | D-88131 | Germany |
| Studio Dentistico Donati | Perugia | IT-06121 | Italy |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Implant Survival Rate | The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal. | Per-protocol analysis set | Posted | Count of Units | Implants | 21 weeks, 12 months, 24 months and 36 months post implant placement. | Implants | Implants |
|
|
|
| Secondary | Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level | MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis. | Per-protocol analysis set. All subjects/implants available for each visit are included in below analyses. | Posted | Mean | Standard Deviation | mm | Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement | Implants | Implants |
|
|
|
| Secondary | Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP) | BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site. | Per-protocol analysis set. All subjects available for each visit are included in below analyses. | Posted | Number | Implants with BoP | 21 weeks, 12 months, 24 months, and 36 months post implant placement | Implants | Implants |
|
|
|
| Secondary | Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration | PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level. | Per-protocol analysis set. All subjects available for each visit are included in below analyses. | Posted | Mean | Standard Deviation | PPD in mm | Baseline and 12 months, 24 months, and 36 months post implant placement | Implants | Implants |
|
|
|
| Secondary | Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration | CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level. | Per-protocol analysis set. All subjects available for each visit are included in below analyses. | Posted | Mean | Standard Deviation | CAL in mm | Baseline and 12 months, 24 months, and 36 months post implant placement | Implants | Implants |
|
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| 0 |
| 65 |
| 2 |
| 65 |
| 0 |
| 65 |
| Melanoma | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin cancer left ring finger |
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| Implants |
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| Implant placement to permanent restoration (implant placement + 21 weeks) |
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| Implant placement to implant placement + 12 months |
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| Implant placement to implant placement + 36 months |
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| 12 months after implant placement |
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| 24 months after implant placement |
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| 36 months after implant placement |
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| Permanent restoration to 24 months post implant placement |
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| Permanent restoration to 36 months post implant placement |
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| Permanent restoration to 24 months post implant placement |
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| Permanent restoration to 36 months post implant placement |
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