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| ID | Type | Description | Link |
|---|---|---|---|
| 10551 | Other Identifier | Tufts University IRB |
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The purpose of the study is to compare one material called "Mucograft" with another material called "Dynamatrix." These materials are used as a type of a barrier (made from pig material also known as porcine material) in a preservation technique to increase the thickness and width of tissues at a tooth extraction site. The investigators want to see if one works better than the other or if they work equally as well. These materials are made up of collagens, which are naturally occurring proteins found in the skin, specifically connective tissue. Dynamatrix is made up of many types of collagens whereas Mucograft is only made of fewer collagens. These materials have been given something called a 510(k) status by the FDA. This means that the FDA determines them to be equivalent to another product that they have previously approved. You will be put into one of two groups at random, and will not know which one you are in. Like flipping a coin, you will have a 50/50 chance to be in either one of the two groups. You will either be in a group using Mucograft or in a group using Dynamatrix. Both of these materials are regularly used in the dental clinics.
A) Aim/Hypothesis/Objective The objective of this study is to compare two different membranes, Mucograft and Dynamatrix, clinically, radiographically, and histologically when used for the ridge preservation procedure in combination with bone allograft at the extraction site in terms of soft and hard tissue remodeling after 4 months healing period.
Hypothesis
Specific Aims
The secondary aims are to compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucograft | Active Comparator | Placement of randomized membrane on half of subjects Mucograft |
|
| Dynamatrix | Active Comparator | Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucograft | Device | Mucograft Collagen Matrix |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Barrier Membranes by Examining Keratinized Tissue | The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM. | 4-6 Months after surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar Bone Height | Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the alveolar bone height at the extraction site. | 4-6 Months after surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Hanley, DMD | TUSDM | Principal Investigator |
| Youngsoo Kim, DDS | TUSDM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available
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| ID | Title | Description |
|---|---|---|
| FG000 | Mucograft | Placement of randomized membrane on half of subjects Mucograft Mucograft: Mucograft Collagen Matrix |
| FG001 | Dynamatrix | Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement Dynamatrix: Dynamatrix |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mucograft | Placement of randomized membrane on half of subjects Mucograft Mucograft: Mucograft Collagen Matrix |
| BG001 | Dynamatrix | Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement Dynamatrix: Dynamatrix |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Compare Barrier Membranes by Examining Keratinized Tissue | The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM. | The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available. | Posted | 4-6 Months after surgical procedure |
|
The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available.
The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available.
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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 | Mucograft | Placement of randomized membrane on half of subjects Mucograft Mucograft: Mucograft Collagen Matrix |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Vice Provost for Research Administration & Development | Tufts University | 617-627-7000 | tss@tufts.edu |
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| Dynamatrix | Device | Dynamatrix |
|
|
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| Secondary | Alveolar Bone Height | Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the alveolar bone height at the extraction site. | The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available. | Posted | 4-6 Months after surgical procedure |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Dynamatrix | Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement Dynamatrix: Dynamatrix | 0 | 0 | 0 | 0 | 0 | 0 |
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