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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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This study compares two ways of placing a dental implant on the day of tooth extraction. One method will place a additional bone graft (derived from bovine bone) and the other group will not have the graft placed. Both groups will be restored at the same time with an immediate crown.
The investigators will be researching and comparing the changes in gum level that occur after each surgical method, as well as changes in jaw width where the implant is placed.
The investigators will enroll 16 patients per group. The patients will be followed for 3, 6, and 12 months post-immediate implant placement to observe healing.
The purpose of the current study is to evaluate the soft tissue dimensional changes after extraction of teeth in the esthetic zone, when combined with the placement of implants into these fresh extraction sockets. In addition, the effect of placing a graft material, such as Bio-Oss Collagen® into the gap between implant and the labial plate of bone will be evaluated after an immediately loaded provisional restoration is placed. 32 subjects will have an immediate dental implant placed in the maxillary anterior region (#4-12) after extraction of a hopeless tooth. 16 subjects will be randomly selected to receive Bio-Oss Collagen® (Test group) and 16 subjects will have no graft (Control group) in the gap between the implant and the labial plate of bone. Hopeless maxillary anterior teeth will be extracted and implants will be placed in a flapless procedure. Implants will be immediately loaded with provisional restorations once determined that the implant is stable. Changes in vertical height and horizontal dimensional changes of the free gingival margins will be evaluated at 3, 6, and 12 months post-immediate implant placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioOss Collagen | Experimental | Intervention: BioOss Collagen at the time of implant placement |
|
| No Bone Graft | No Intervention | No placement of BioOss at the time of implant placement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioOss Collagen at the time of implant placement | Device | Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Bucco-Lingual Change at 3mm | The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured. | Baseline and 12 months |
| Mean Bucco-Lingual Change at 4mm | The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Baseline and 12 months |
| Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurit Bittner Fogel, DDS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University, College of Dental Medicine | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BioOss Collagen | Intervention: BioOss Collagen at the time of implant placement BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen |
| FG001 | No Bone Graft | No placement of BioOss at the time of implant placement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BioOss Collagen | Intervention: BioOss Collagen at the time of implant placement BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen |
| BG001 | No Bone Graft |
| 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 | Mean Bucco-Lingual Change at 3mm | The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured. | Posted | Mean | Standard Deviation | mm | Baseline and 12 months |
|
From baseline to 12 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 | BioOss Collagen | Intervention: BioOss Collagen at the time of implant placement BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen |
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The sample size for this study is limited, as well as the overall follow up of the patients. Further, studies with longer follow up times may be recommended to evaluate long term behavior of the tissues with immediately placed implants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nurit Bittner, DDS, MS, Dip.ABP | Columbia University | 212-342-2763 | nb2203@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2016 | May 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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The mean change was calculated from a tooth-supported stent to the free gingival margin.
| Baseline and 12 months |
| Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Baseline and 12 months |
| Periodontal Probing Depth | The periodontal probing depth will be measured in mm. | 12 months |
| Thickness of Keratinized Tissue at 3mm | Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | 12 months |
| Thickness of Keratinized Tissue at 4mm | Tissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | 12 months |
| Thickness of Keratinized Tissue at 8mm | Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | 12 months |
No placement of BioOss at the time of implant placement
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Smokers | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Mean Bucco-Lingual Change at 4mm | The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured. | Posted | Mean | Standard Deviation | mm | Baseline and 12 months |
|
|
|
| Secondary | Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Posted | Mean | Standard Deviation | mm | Baseline and 12 months |
|
|
|
| Secondary | Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Posted | Mean | Standard Deviation | mm | Baseline and 12 months |
|
|
|
| Secondary | Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Posted | Mean | Standard Deviation | mm | Baseline and 12 months |
|
|
|
| Secondary | Periodontal Probing Depth | The periodontal probing depth will be measured in mm. | Data for this outcome measure was not collected and analyzed since all the patients on the study were periodontally healthy and showed no signs of soft tissue inflammation. | Posted | 12 months |
|
|
| Secondary | Thickness of Keratinized Tissue at 3mm | Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
|
| Secondary | Thickness of Keratinized Tissue at 4mm | Tissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
|
| Secondary | Thickness of Keratinized Tissue at 8mm | Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | No Bone Graft | No placement of BioOss at the time of implant placement | 0 | 16 | 0 | 16 | 0 | 16 |
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