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The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implants placed at sub-crestal position. | Experimental | Ankylos dental endosseous implants-Sub-crestal |
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| Epi-crestal implants. | Active Comparator | Ankylos dental endosseous implants-Epi-crestal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankylos dental endosseous implants-Sub-crestal | Device | Implants placed subcrestally |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Marginal Bone Level (MBL) | Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30. | Implant placement, and 18 months and 30 months after implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mid-Buccal Soft Tissue Height | Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position. | From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart J Froum, DDS | Bluestone Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bluestone Center for Clinical Research | New York | New York | 10010-4086 | United States |
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| Label | URL |
|---|---|
| Bluestone Clinic at NYU | View source |
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Of the 1022 participants who were assessed for eligibility, 974 were excluded as they did not meet the inclusion criteria, did not show for evaluation, or for other reasons. Forty-eight (48) met inclusion criteria and were randomized to treatment.
Subjects who fulfilled the inclusion criteria and required two bilateral implants in the pre-molar (first or second) or molar (first or second) region of the maxilla or mandible, ages 18 through 70 years old were eligible to participate in this study. Patient screenings, enrollment, study procedures, and data collection was conducted at the Bluestone Center for Clinical Research (BCCR), New York University (NYU) College of Dentistry, from April 2012 to April 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | Implants Placed at Sub-crestal Position | Ankylos dental endosseous implants placed at sub-crestal position |
| FG001 | Implants Placed at Epi-crestal Position | Ankylos dental endosseous implants placed at epi-crestal position |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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This was a split mouth study design in which the same patient was used for both arms.
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| Ankylos dental endosseous implants-Epi-crestal | Device | Implants placed Epi-crestally |
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| Change of Interproximal Levels After Final Restoration | Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published "papilla Jemt index". Measurements will be assessed by reviewing the clinical photographs. Reference: Jemt, T. (1997) "Regeneration of gingival papillae after single-implant treatment". International Journal of Periodontics and Restorative Dentistry 17: 326-333. | From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement |
| Change in Marginal Bone Level (MBL) | Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66. | Implant placement, and 66 months after implant placement |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Implants Placed at Sub-crestal Position and Epi-crestal Position | Ankylos dental endosseous implants-sub-crestal and epi-crestal Ankylos dental endosseous implants-sub-crestal and epi-crestal: Implants placed subcrestally and epi-crestally |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Change in Marginal Bone Level (MBL) | Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30. | All subjects available at each time point are included in the analysis. | Posted | Mean | Standard Deviation | mm | Implant placement, and 18 months and 30 months after implant placement | implants | implants |
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| Secondary | Change in Mid-Buccal Soft Tissue Height | Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position. | All subjects available at each time point are included in the analysis. | Posted | Mean | Standard Deviation | mm | From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement | implants | implants |
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| Secondary | Change of Interproximal Levels After Final Restoration | Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published "papilla Jemt index". Measurements will be assessed by reviewing the clinical photographs. Reference: Jemt, T. (1997) "Regeneration of gingival papillae after single-implant treatment". International Journal of Periodontics and Restorative Dentistry 17: 326-333. | All subjects available at each time point are included in the analysis. | Posted | Mean | Standard Deviation | mm | From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement | implants | implants |
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| Secondary | Change in Marginal Bone Level (MBL) | Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66. | Posted | Mean | Standard Deviation | mm | Implant placement, and 66 months after implant placement | implants | implants |
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Adverse event data was collected from initial implant to 60 months after final restoration
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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 | Implants Placed at Sub-crestal Position | Ankylos dental endosseous implants placed at sub-crestal position | 1 | 48 | 2 | 48 | 17 | 48 |
| EG001 | Implants Placed at Epi-crestal Position | Ankylos dental endosseous implants placed at epi-crestal position | 1 | 48 | 2 | 48 | 11 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Note: Cause of death is unknown and therefore "General disorders" was selected. |
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| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | An accident involving a fractured upper and lower jaw (trauma adjacent to a study implant) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Healing abutment lost | Product Issues | Systematic Assessment |
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| Provisional crown loosened/lost | Product Issues | Systematic Assessment |
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| Provisional crown chipped/fractured | Product Issues | Systematic Assessment |
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| Final crown loosened/lost | Product Issues | Systematic Assessment |
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| Final crown chipped/fractured | Product Issues | Systematic Assessment |
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Several limitations within the present study should be noted with regard to: 1) CT scan performance, 2) intraoral radiograph outcomes, 3) soft tissue level outcomes, 4) periodontal and peri-implant status, and 5) restorative procedures.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ismael Khouly | NYU College of Dentistry | 212-998-9800 | iek3@nyu.edu |
| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Mean MBL (Lingual) at 18 months after implant placement |
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| Mean MBL (Buccal) at 30 months after implant placement |
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| Mean MBL (Lingual) at 30 months after implant placement |
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