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The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix® (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and Equimatrix®, when placed in extraction sockets.
Participants will be recruited from patients in the TUSDM clinics that require extraction of single rooted non-molar tooth and are treatment planned to receive dental implants in the future. Participants will be randomized to receive one of the three xenograft materials after tooth extraction. The percentage of newly formed bone and bone density will be compared between the three materials 4-6 months after ridge preservation.
This is a pilot prospective clinical trial in which histological and micro CT analysis will be utilized to compare between Endobon®, Equimatrix®, and Bio-Oss®.
Primary aim: Compare the percentage of newly formed bone between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the mean percentage of newly formed bone from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
Secondary aim: Compare the bone density between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the bone density from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Equimatrix® | Experimental | Equimatrix® + Mucograft or alternatives |
|
| Bio-Oss® | Experimental | Bio-Oss® + Mucograft or alternatives |
|
| Endobon® | Experimental | Endobon® + Mucograft or alternatives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equimatrix® | Device | Ridge preservation bone grafting after tooth extraction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent New Bone Formation | Histomorphometric determination of % new bone formation | 4-6 months after ridge preservation surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density | Measured by Micro CT Scanning | 4-6 months after ridge preservation surgery |
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Inclusion Criteria:
Exclusion Criteria:
Poor oral hygiene (plaque index>30%).
Systemic diseases that affect bone metabolism:
i. Osteoporosis ii. Osteomalacia iii. Hyperthyroidism iv. Hyperparathyroidism v. Paget's disease
Inflammatory and autoimmune diseases of the oral cavity (severe bone loss) (self-report):
i. Severe chronic periodontitis ii. Aggressive periodontitis iii. Necrotizing ulcerative periodontitis iv. Crohn's disease v. Multiple sclerosis vi. Rheumatoid arthritis vii. Systemic lupus erythematosus
History of radiation to the head and neck, and /or chemotherapy.
Current corticosteroid therapy.
History of IV Bisphosphonates therapy or >3 years of oral intake.
Infectious diseases such as HIV, tuberculosis, Hepatitis (self-report).
Known allergy to research related materials.
Self-reported pregnancy or lactation
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| Name | Affiliation | Role |
|---|---|---|
| Yong Hur, DDS, DMD, MS | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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25 subjects were screened. However, only 21 subjects were enrolled. 4 patients didn't participate the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Equimatrix® | Equimatrix® + Mucograft or alternatives Equimatrix®: Ridge preservation bone grafting after tooth extraction |
| FG001 | Bio-Oss® | Bio-Oss® + Mucograft or alternatives Bio-Oss®: Ridge preservation bone grafting after tooth extraction |
| FG002 | Endobon® | Endobon® + Mucograft or alternatives Endobon®: Ridge preservation bone grafting after tooth extraction |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Equimatrix® | Equimatrix® + Mucograft or alternatives Equimatrix®: Ridge preservation bone grafting after tooth extraction |
| BG001 | Bio-Oss® | Bio-Oss® + Mucograft or alternatives Bio-Oss®: Ridge preservation bone grafting after tooth extraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent New Bone Formation | Histomorphometric determination of % new bone formation | Posted | Mean | Standard Deviation | percentage of new bone formation | 4-6 months after ridge preservation surgery |
|
1 year
Adverse events were recorded in source documents and on case report forms. All adverse events were recorded, monitored, and reported to the IRB at time of continuing review or at the study's termination. None of the participants had adverse events to report during the study period.
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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 | Equimatrix® | Equimatrix® + Mucograft or alternatives Equimatrix®: Ridge preservation bone grafting after tooth extraction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yong Hur | Tufts University | 6176366531 | Yong.Hur@tufts.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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The surgeon and the subject will not be blinded. The evaluation of the core histology will be done by a blinded investigator.
| Bio-Oss® |
| Device |
Ridge preservation bone grafting after tooth extraction |
|
| Endobon® | Device | Ridge preservation bone grafting after tooth extraction |
|
| BG002 | Endobon® | Endobon® + Mucograft or alternatives Endobon®: Ridge preservation bone grafting after tooth extraction |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Endobon® + Mucograft or alternatives
Endobon®: Ridge preservation bone grafting after tooth extraction
|
|
| Secondary | Bone Density | Measured by Micro CT Scanning | The micro-CT data was anaylzed as a preliminary outcome of the primary outcome. A total of 10 patient data was used. | Posted | Mean | Standard Deviation | percentage of bone volume | 4-6 months after ridge preservation surgery |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Bio-Oss® | Bio-Oss® + Mucograft or alternatives Bio-Oss®: Ridge preservation bone grafting after tooth extraction | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Endobon® | Endobon® + Mucograft or alternatives Endobon®: Ridge preservation bone grafting after tooth extraction | 0 | 7 | 0 | 7 | 0 | 7 |
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| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |