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This study will involve placing donor bone into the back of lower jaw then covering with a newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it will be removed. Implants will be placed in the newly formed bone.
The goal of this study is to test how well using a newly designed titanium mesh and bone particles can grow bone in the back of the lower jaw. The investigators are also checking if the newly formed bone will stay around implants that will have been in use for 12 months.
Inclusion Criteria
Exclusion Criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone/Mesh | Experimental | Allograft and Titanium mesh will be used to grow jaw bone vertically. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone/Mesh | Device | A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Height | Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsun-Liang Chan, DDS, MS | University of Michigan | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26133141 | Result | Chan HL, Benavides E, Tsai CY, Wang HL. A Titanium Mesh and Particulate Allograft for Vertical Ridge Augmentation in the Posterior Mandible: A Pilot Study. Int J Periodontics Restorative Dent. 2015 Jul-Aug;35(4):515-22. doi: 10.11607/prd.1980. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone/Mesh | Allograft and Titanium mesh will be used to grow jaw bone vertically. Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone/Mesh | Allograft and Titanium mesh will be used to grow jaw bone vertically. Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Height | Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images. | Posted | Mean | Full Range | millimeters | 5 months |
|
|
2 years 6 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 | Bone/Mesh | Allograft and Titanium mesh will be used to grow jaw bone vertically. Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Failure | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hsun-Liang Chan | University of Michigan | 734-763-3325 | hlchan@umich.edu |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| Implant Failure |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bone height | Mean | Full Range | millimeters |
|
|
| 0 |
| 10 |
| 7 |
| 10 |
| Mesh Exposure/Removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Hypoxic Tissue | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lack of Bone Growth | Surgical and medical procedures | Non-systematic Assessment |
|
| Wound Opening at Mesh site | Surgical and medical procedures | Non-systematic Assessment |
|
| Soft Tissue Dehiscence | Surgical and medical procedures | Non-systematic Assessment |
|
| Soreness on Tongue | General disorders | Non-systematic Assessment |
|
| Throbbing Pain | General disorders | Non-systematic Assessment |
|
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| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |