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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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This study will be a randomized clinical trial involving a total of 24 subjects. The investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All subjects recruited will have already been approved and treatment planned for extraction + implant placement by non-study personnel to avoid any potential conflict of interest. All subjects will have radiographs that show the tooth planned for extraction. Each subject will be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth extraction, subjects will receive a standard site preservation therapy consisted with xenograft bone substitute + collagen dressing or the alternative site preservation therapy consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month healing period, subjects will receive a dental implant in the previous extracted site. During the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be obtained from the implant site. Biopsy samples will be stored for future histological and histochemical analysis. After dental implant placement, all subjects will receive a healing abutment for soft tissue healing prior to implant restoration.
During the 6-month healing time after tooth extraction and site preservation therapy, subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate extraction planning and at 6-month post-extraction for volumetric measurement and appropriate implant treatment planning.
Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs. 6-month healing). CBCT images will be analyzed by non-contact reverse engineering system. Soft tissue volumetric analysis will be performed to compare the soft tissue healing between BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). |
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| Control | Active Comparator | Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenograft bone substitute | Device | Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Buccal Plate Thickness From Baseline to Month 6 | The thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography. | 6 months |
| Change in Buccal Soft Tissue Volume Between Baseline and 6 Months | The soft tissue volume change between baseline and 6 months based on 3D images captured with intra-oral digital scanner. | 6 months |
| Change in Buccal Bone Volume Between Baseline and 6 Months | The buccal bone volume change between baseline and 6 months will be calculated from cone-beam computed tomography data. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Marchesan, DDS, PhD | Assistant Professor Periodontology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General & Oral Health Center | Chapel Hill | North Carolina | 27599-7450 | United States |
Deidentified individual data that supports the results will be shared beginning 9-36 months following publication.
9-36 months following publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site. 3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jul 20, 2016 |
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| Collagen dressing | Device | Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site. |
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| 3D-collagen matrix | Device | Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site. |
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| FG001 | Control | Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®). Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site. Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site. 3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site. |
| BG001 | Control | Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®). Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site. Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Full Range | years |
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| Sex: Female, Male | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Buccal Plate Thickness From Baseline to Month 6 | The thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography. | Posted | Mean | Standard Deviation | mm | 6 months |
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| Primary | Change in Buccal Soft Tissue Volume Between Baseline and 6 Months | The soft tissue volume change between baseline and 6 months based on 3D images captured with intra-oral digital scanner. | Posted | Mean | Standard Deviation | mm^3 | 6 months |
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| Primary | Change in Buccal Bone Volume Between Baseline and 6 Months | The buccal bone volume change between baseline and 6 months will be calculated from cone-beam computed tomography data. | Posted | Mean | Standard Deviation | mm^3 | 6 months |
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From time of extraction through 7 months after extraction
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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 | Test | Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site. 3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | Control | Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®). Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site. Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thiago Morelli | University of North Carolina at Chapel Hill | 919-537-3727 | thiago_morelli@unc.edu |
| Jan 14, 2019 |
| Prot_SAP_000.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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