Alveolar Bone Loss
Conditions
Keywords
dental, tooth, implant, extraction, Oral, Surgical, Procedures
Brief summary
The purpose of this research is to determine if a subject's own bone marrow tissue can help regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair Cell (TRC) Therapy.
Detailed description
A sample of the subject's bone marrow tissue will be collected and sent to a laboratory where it will be processed to form cells. The new cells are transplanted into the tooth socket after the tooth has been removed. The researchers are testing to see if these cells (TRC) will help form bone. The research will also determine if the implant the subject receives will be more stable in the area with new bone growth.
Interventions
BIOLOGICALTissue Repair Cells (TRC)
30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket.
DEVICEControl
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Sponsors
Vericel Corporation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age range: 20 to 70 years * Gender: Male and female * Patients must be able and willing to follow study procedures and instructions * Patients must have read, understood and signed an informed consent form * Patients must require tooth extraction as a result of caries, periodontal disease, or tooth fracture
Exclusion criteria
* Allergies or hypersensitivities to study related medications: amoxicillin, dexamethasone, chlorhexidine, ibuprofen, ranitidine * Hematologic disorders/ blood dyscrasias * Active infectious disease * Liver or kidney dysfunction/failure- Patients will have blood drawn for serum laboratory tests, including creatinine, blood urea nitrogen (BUN), aspartate aminotransferase (AST), alanine aminotransferase test (ALT), and bilirubin. All of these must be within normal limits for a patient to be included in the study. Current University of Michigan Health System normal lab values are as follows: Creatinine (male 0.7-1.3 mg/dl; female 0.5-1.0 mg/dl); BUN (8-20 mg/dl); AST (8-30 IU/L); ALT (7-35 IU/L); Bilirubin (0.2-1.2 mg/dl). * Endocrine disorders/dysfunctions (i.e Type I and II diabetes) * Cancer - The explicit definition of cancer used to exclude patients is consistent with that described by the National Cancer Institute (NCI), National Institutes of Health. According to NCI, cancer is any disease in which abnormal cells divide without control and invade nearby tissues (invasive disease). These include carcinomas, sarcomas, leukemias, and lymphomas. Any patient with a history of these invasive diseases will be excluded from the study. * Patients who currently use bisphosphonates or have a history of bisphosphonate use will be excluded from the trial. * HIV+ * Metabolic Bone Diseases-Patients with metabolic bone diseases such as Paget's disease, hypercalcemia, moderate to severe vitamin D3 abnormalities or any other metabolic bone disease including osteoporosis and osteoporotic fractures will be excluded. The following scale will be used to determine osteoporosis in patients who have had a bone mass density (BMD) determination: Normal = T score at or above -1.0 SD; Osteopenia = T score between -1.0 and -2.5 SD; Osteoporosis = T score at or below -2.5 standard deviation (SD). Although a dexa scan will not be required, all post-menopausal women receiving osteoporosis/osteopenia related therapy will receive a dexa scan as part of their standard medical care. * Additionally, individuals who have a medical history significant for diabetes will not be included in the study. * Laboratory values that will define normal renal and hepatic function, as well as criteria for exclusion of metabolic bone disease are consistent with those established by the University of Michigan Health System (UMHS). Normal clinical values will be used to help assure the health of all subjects in this trial. * Individuals who have a BMI outside normal limits or a BMI that deems them overweight (BMI \>25) will be excluded due to potential difficulties in locating appropriate surgical entry of the iliac crest during bone marrow aspiration procedure. * The following additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Regeneration | 12 months after tooth extraction | The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction. * Safety was assessed through adverse event reporting * Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Successfully Received Dental Implant Fixtures | 12 months after tooth extraction | The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier | 12 |
| Control Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 11 | 53 years STANDARD_DEVIATION 14 | 50 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 3 / 12 |
Outcome results
Primary
Bone Regeneration
The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction. * Safety was assessed through adverse event reporting * Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)
Time frame: 12 months after tooth extraction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Repair Cells (TRC) | Bone Regeneration | 79 % bone height | Standard Deviation 10 |
| Control | Bone Regeneration | 63 % bone height | Standard Deviation 16 |
Secondary
Number of Participants Who Successfully Received Dental Implant Fixtures
The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures
Time frame: 12 months after tooth extraction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tissue Repair Cells (TRC) | Number of Participants Who Successfully Received Dental Implant Fixtures | 12 participants |
| Control | Number of Participants Who Successfully Received Dental Implant Fixtures | 12 participants |