Alveolar Bone Loss
Conditions
Brief summary
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.
Detailed description
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®.
Interventions
DEVICEEquimatrix®
Ridge preservation bone grafting after tooth extraction
DEVICEBio-Oss®
Ridge preservation bone grafting after tooth extraction
DEVICEEndobon®
Ridge preservation bone grafting after tooth extraction
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The surgeon and the subject will not be blinded. The evaluation of the core histology will be done by a blinded investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Non-restorable single rooted tooth in anterior or premolar region * Patient previously treatment planned for implant procedure and implant restoration. * \> 10 mm from maxillary sinus or inferior alveolar canal (IAC) * Intact buccal bone (only minor dehiscence or fenestrations (approximately \< 50% of socket depth) can be accepted * Non-smokers. * Patients treatment planned for extraction and ridge preservation at Tufts University School of Dental Medicine.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent New Bone Formation | 4-6 months after ridge preservation surgery | Histomorphometric determination of % new bone formation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Density | 4-6 months after ridge preservation surgery | Measured by Micro CT Scanning |
Countries
United States
Participant flow
Pre-assignment details
25 subjects were screened. However, only 21 subjects were enrolled. 4 patients didn't participate the study.
Participants by arm
| Arm | Count |
|---|---|
| Equimatrix® Equimatrix® + Mucograft or alternatives
Equimatrix®: Ridge preservation bone grafting after tooth extraction | 8 |
| Bio-Oss® Bio-Oss® + Mucograft or alternatives
Bio-Oss®: Ridge preservation bone grafting after tooth extraction | 6 |
| Endobon® Endobon® + Mucograft or alternatives
Endobon®: Ridge preservation bone grafting after tooth extraction | 7 |
| Total | 21 |
Baseline characteristics
| Characteristic | Bio-Oss® | Endobon® | Equimatrix® | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 5 Participants | 16 Participants |
| Age, Continuous | 55.2 years STANDARD_DEVIATION 12.6 | 53.5 years STANDARD_DEVIATION 7.1 | 60.3 years STANDARD_DEVIATION 8.7 | 56.7 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 6 participants | 7 participants | 8 participants | 21 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 7 |
Outcome results
Primary
Percent New Bone Formation
Histomorphometric determination of % new bone formation
Time frame: 4-6 months after ridge preservation surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Equimatrix® | Percent New Bone Formation | 41 percentage of new bone formation | Standard Deviation 30 |
| Bio-Oss® | Percent New Bone Formation | 25 percentage of new bone formation | Standard Deviation 18 |
| Endobon® | Percent New Bone Formation | 26 percentage of new bone formation | Standard Deviation 26 |
Secondary
Bone Density
Measured by Micro CT Scanning
Time frame: 4-6 months after ridge preservation surgery
Population: The micro-CT data was anaylzed as a preliminary outcome of the primary outcome. A total of 10 patient data was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Equimatrix® | Bone Density | 25.6 percentage of bone volume | Standard Deviation 18.7 |
| Bio-Oss® | Bone Density | 23.0 percentage of bone volume | Standard Deviation 7.9 |
| Endobon® | Bone Density | 12.9 percentage of bone volume | Standard Deviation 11.1 |